The post The IRT Landscape: Regulations, Challenges and Solutions – White Paper appeared first on ArisGlobal.

Pay-As-You-Grow Service Offering Delivers Competitive Edge to CROs looking for more Sponsors and Clinical Trials

CHICAGO, IL.  DECEMBER 14, 2016 — ArisGlobal, a leading provider of integrated, cloud-based software solutions for life sciences, has announced a one-of-a-kind Agile clinical research organization (CRO) solution platform that provides transformational clinical development solutions to CROs of all sizes to help them accelerate clinical trials and grow their business with their sponsors.

The first-to-market Agile CRO program responds to the classic Catch-22 problem facing smaller and even mid-sized CROs: how to protect their businesses and even extend their reach by enabling them to run more trials with more sponsors, without the resources to purchase expensive validated tools and systems needed to meet stringent regulatory requirements.

• Webinar Replay: Learn How CROs Can Boost Profits and Productivity
• Infographics: Overcoming the Clinical Disconnect |  Agile CRO Program
• Customer Story: Global CRO Chooses ArisGlobal to Manage Clinical and Pharmacovigilance
• Blog: Becoming an Agile CRO with the ArisGlobal Pay-As-You-Grow Partner Program

According to Gartner’s Hype Cycle for Life Sciences, 2016 report:  …“Controlling clinical resource costs will require a combination of tools and approaches, but this will evolve as demand for integrated solutions across all clinical trials and CRO partners seeks to create the holistic and integrated view of clinical studies that is required to optimize resources.”¹

Responding to this pressing business need, ArisGlobal has created an innovative pay-as-you-grow pricing plan that provides low cost of entry, allowing an organization to implement a technology solution where they may have thought it was not possible before. The solution is flexible enough to meet short-term needs and at the same time is functionally complete enough to serve as entire research platform.

“The solution enables CROs of all sizes to compete in the market place,” says David Laky, Vice President and General Manager, Clinical Solutions. “This is irrespective of whether a CRO is using traditional CTMS and CDMS/EDC capabilities or adding new capabilities and potentially new revenue streams by implementing eTMF, auto-encoding, SUSAR distribution and tracking, clinical trial transparency reporting, or one or more of our other data driven functional modules.”

ArisGlobal’s Agile CRO program provides out-of-the-box solutions, spanning both clinical operations and clinical data management, built on industry requirements that can be configured to each CRO’s specific needs. The cloud-based platform also comes with an enterprise transaction layer or clinical backend as-a-service layer that enables integration to third-party or homegrown applications.

“The cloud-based platform includes built in workflow, notifications and alerts that enable real-time visibility to critical tasks and provides the capability to generate to-do lists,” says Philip Strickland, ArisGlobal’s Strategic Account Manager, Clinical Solutions.

ArisGlobal’s transparent and innovative pricing is geared toward how CROs interact with their customers. Certain modules are priced at the study level, while other modules are priced at the transaction level, but all modules are geared toward pricing on an as-needed basis.

“The pay-as-you-grow approach is devised to ensure flexibility so that CROs can direct their resources toward activities that will help them grow their business,” Laky adds.

¹ Gartner, Hype Cycle for Life Sciences, 2016, July 2016

About ArisGlobal

ArisGlobal’s cloud-based solutions support the life sciences and healthcare industries across the entire product life cycle including clinical development, regulatory affairs, pharmacovigilance and medical communications. Hundreds of drug and device manufacturers, CROs and regulatory agencies leverage ArisGlobal’s advanced technology solutions spanning regulatory information management, pharmacovigilance regulatory reporting, medical information and clinical trial management software to make better and more informed decisions, facilitate compliance, reduce risk, and improve operational efficiency. Headquartered in the United States, ArisGlobal has regional offices in Europe, India and Japan. For more information, visit arisglobal.com or follow ArisGlobal on LinkedIn and Twitter.

The post ArisGlobal Announces First-To-Market Agile Clinical Research Organization Program appeared first on ArisGlobal.

Recent article demonstrates the pivotal role of medical affairs

Medical Affairs teams have long played a role in the life cycle of a drug going to market and staying in market.  But, is their role changing?  Are Medical Affairs teams becoming the lynchpin to Phase IV studies?  Are they finally getting the “respect” they deserve given the information they handle?  And, if they are stepping up in Phase IV studies – what does it mean to the information they gather, how they report it, and to whom they report it to?

The main objective of Phase IV post-marketing studies is to collate data on the drug’s effect in various populations and its efficacy during long-term use. A recent article in Outsourcing-Pharma.com highlighted the pivotal role medical affairs teams play in these studies.

The survey results showed:

• “93% of medical affairs teams are integral to the strategic planning process, with Compliance and Regulatory teams showing 73% and 63% involvement, respectively”
• “68% of medical affairs teams are involved directly with the study execution, with Clinical Development and Compliance teams showing 50% and 36% involvement, respectively”

In addition to the core objective, Phase IV studies can provide vital data which will shape the drug company’s commercial marketing strategy – and medical affairs teams are at the heart of this process.

With the likelihood of post-marketing studies becoming mandatory practice in the future, it seems fitting that medical affairs professionals, with their expertise in multi-channel communication (with Healthcare Professionals, Medical Science Liaisons, Sales, medical information groups) would drive Phase IV study strategy.  But, they can only do this if they are armed with the right insight tools and right processes, i.e. using continued insights from internal and external customers to refine and interpret the results.

With this in mind, medical affairs teams can plan now for future success: ensuring the capabilities are in place for handling increased multi-channel communication while efficiently handling reports from multiple internal and external sources.

Is your medical affairs team challenged with having to handle increasing channels of communication? Learn more about ArisGlobal’s medical communications software and find out how it can help provide insights, automate, integrate and streamline your medical affairs processes.

The post Medical affairs teams at the heart of Phase IV studies appeared first on ArisGlobal.

The post Regulatory Submissions Webinar appeared first on ArisGlobal.

CHICAGO, IL.  January 3, 2017 — ArisGlobal, a leading provider of cloud-based software solutions for the life sciences, has announced four new clients that are using its integrated safety intelligence, signal management and risk management platform agBalance.

Several factors are prompting organizations to adopt agBalance: ease of integration with existing safety systems, its ability to manage complex signal management process and regulatory requirements, the growing emphasis on risk management planning and effectiveness measurement, and a simpler, more intuitive user interface.

• VIDEO: ArisGlobal’s agBalance |  Learn More

“In today’s digital world, with continued focus on patient safety in an increasingly stringent regulatory environment, organizations need an intelligent platform that allows their safety departments to manage information in the most effective and efficient manner possible,” said Sharad Prakash, Vice President, Safety Analytics and Risk Management at ArisGlobal. “agBalance enables end-to-end safety signal life cycle management through systematic processes resulting in well executed risk minimization strategies.”

One top-tier European pharmaceutical company faced a myriad of challenges, including the integration of its drug safety system and signal detection platform, an inability to manage signals from sources to recommendations, and complexity in producing time-critical business and regulatory reports. After careful evaluation, the company found agBalance perfectly fit its current and future needs for signal detection and risk management.

A European National Competent Authority selected agBalance for its intuitive user interface and robust workflow engine to streamline signal detection and management activities. agBalance’s better signal detection, pharmacovigilance analytics, and advanced visualization capabilities were significant differentiators.

A mid-tier, U.S.-based pharmaceutical company found the solution fits its needs with regards to drug safety system integration, its ability to access comprehensive pharmacovigilance analytics across all safety sources, and for the integrated Risk Management Planning and Distribution module to support regional and country-level requirements.

In Japan, a leading pharmaceutical company sought integration with its existing drug safety systems for local and foreign adverse event reports, the ability to analyze data from multiple sources, all in a solution that could respond to the company’s complex signal management processes.

“The global interest in agBalance underscores the importance organizations are placing on proactive safety surveillance and structured risk management strategies,” added Prakash.

About ArisGlobal

ArisGlobal’s cloud-based solutions facilitate global drug development and regulatory compliance within the life sciences and healthcare industries. Its cloud platform supports the entire product life cycle including clinical development, regulatory affairs, safety and pharmacovigilance and medical communications. Hundreds of drug and device manufacturers, CROs and regulatory agencies leverage ArisGlobal’s advanced technology solutions spanning regulatory information management, risk evaluation and mitigation strategies, medical information and clinical trial management software to make better and more informed decisions, facilitate compliance, reduce risk, and improve operational efficiency. Headquartered in the United States, ArisGlobal has regional offices in Europe, India and Japan. Visit arisglobal.com, or follow ArisGlobal on LinkedIn and Twitter.

The post ArisGlobal Wins Growing Client Base for Drug Safety and Risk Management Platform agBalance appeared first on ArisGlobal.

Get help at upcoming Pharmacovigilance and Risk Management Strategies Conference

Just as 2017 looks to be another strong year for pharma, it will continue to pose challenges for safety and pharmacovigilance professionals worldwide. The quick-fix, “same as we did last year” simply won’t cut it as solving these complex challenges requires new, innovative and bold approaches.

When the stakes are this high and the challenges are this complex you need expertise from proven leaders with practical, real-world experience like Dr. Krishna Bahadursingh.

Dr. Bahadursingh’s is the Senior Vice President of Safety and Risk Management with ArisGlobal. His breadth of experience affords him a unique perspective and expertise in developing comprehensive solutions to life sciences organizations’ most pressing safety challenges. He joined the pharma industry from clinical practice, after which he spent over a decade in multi-disciplinary leadership roles central to ensuring patient safety and regulatory compliance at Eisai, Co., Ltd.’s Tokyo headquarters and Head of Safety and Risk Management at MSD Tokyo, Japan.

You can meet Dr. Bahadursingh at DIA’s upcoming Pharmacovigilance and Risk Management Strategies Conference January 23^rd-25^th in Washington, DC. He can provide insights into the challenges below and more:

• How you can support the demands of an increased workload with flat or reduced resources
• Ways you can automate case processing tasks so you can focus on proactive activities like signal detection
• The importance of eliminating risk, not just managing it
• Why you need a partner, not a vendor, to work with you to solve your business challenges

DIA’s Pharmacovigilance and Risk Management Strategies Conference will focus on cutting-edge innovation across the entire life cycle of biopharmaceutical products – new therapeutic approaches to diseases that change patients’ lives, enlightened evolution of regulatory science that speeds needed products to prescribers and patients, and, most importantly, engagement of patients in the product development and regulatory processes.

We look forward to seeing you at the upcoming conference and hope you can meet with Dr. Krishna and other leaders from ArisGlobal to discuss your challenges and how our market-leading safety platform can help you meet your goals!

Related: Webinar, “How Safety Departments Can Overcome Resource Challenges”

The post Need Help Solving Your Complex Safety Challenges? appeared first on ArisGlobal.

As the outsourcing trend continues to grow, many biopharmaceutical and pharmaceutical companies find themselves needing to partner with CROs (contract research organizations) that are seasoned and can provide broad areas of safety support. To meet these needs, CROs in turn have built capacities to ensure that they have a robust safety platform with a qualified team of safety experts and personnel to help manage clinical trials and flag potential cases via signal detection

Underscoring the trend is the fact that product safety forces industry leaders in CROs to better understand when to perform proper analysis of adverse events. Today, it’s more critical than ever to establish a risk/benefit profile, develop  risk mitigation and management plans, identify potential  signals and manage other safety concerns.

To meet these demands a global CRO needed a technology solution so they could service the needs of their clients quickly and inexpensively. This global CRO chose ArisGlobal’s world-class safety solution.

ArisGlobal’s solutions allowed them to triage all the cases quickly and accurately while identifying potential cases.

Read the success story to learn how a leading CRO joins with ArisGlobal’s to provide its clients with an agile solution that would help them remain current with continually evolving regulations.

Contact us to learn how ArisGlobal can help your team transform their PV and safety processes too.

The post If You’re a CRO, You’ll Want to Read This Success Story appeared first on ArisGlobal.

With declining R&D budgets, increased competition from larger CROs and patent expirations, emerging CROs have evolved from being non-core service providers to being integral partners in the earliest to the latest stages of the drug discovery and development process. According to a Grand View Research report, the global healthcare CRO market is expected to reach $45.2 billion by 2022 ( Source: Outsourcing-Pharma.com).

Thus, the large global players today dominate the Clinical CRO market.  Given this, outsourcing will continue to grow for the foreseeable future, and this holds the potential for huge business growth for the CRO who can capture a decent share of the available opportunities. For the large, well-known CROs, these opportunities will continue to come their way easily.

Emerging CROs face a harder, uphill battle to run more trials based on the sponsors’ requirements – in large part due to lack of technological expertise and legacy systems in place today. ArisGlobal has recently announced a first-to-market “Agile CRO Program” that empowers emerging CROs to expand its services offerings across the entire drug development and discovery process, i.e. from clinical trials to regulatory submissions and data management.

To remain competitive, emerging CROs need to position themselves as niche service providers. They have greater potential to meet the sponsors’ requirements and act as an integral part of the drug development process.  There is vast potential available for emerging CROs to adopt new technologies for improving their service offerings to obtain market share, garner new sponsors and drive more revenues.

In a nutshell, ArisGlobal’s Agile CRO program is a healthy technological proposition for emerging CROs to drive end-to-end clinical processes in today’s highly dynamic clinical world.

Feel free to drop by and visit ArisGlobal at Booth #405 at the upcoming SCOPE Summit 2017 conference this January 24-26 in Miami. Not going to the SCOPE Summit? Contact us at info@arisglobal.com or visit us at http://www.arisglobal.com/cro_pay_as_you_grow/.

The post A level playing field: Realizing the importance of emerging CROs appeared first on ArisGlobal.

Chicago, Illinois, January, 23 2017 — ArisGlobal, a leading provider of integrated, cloud-based software solutions for life sciences, announces agClinical 3.3, the latest version of its comprehensive clinical trial management software. This release further enables life science organizations to confidently and efficiently meet new compliance and submission requirements, improve risk-based monitoring and better manage the electronic trial master file so that compliance is assured and transparency is improved.

• Data Sheet: ArisGlobal’s agClinical
• Webinar Replays: How CRO’s Can Boost Profits and Productivity |  The Value of Unified CTMS/eTMF

“We benefit from a collaborative relationship with our customers, and we have taken their valued, best-practices input and added new functionality to our already comprehensive solution to position our customers for success,” said David Laky, ArisGlobal’s General Manager and VP, Clinical Development. “We are confident that agClinical 3.3 responds to their need for reducing the labor-intensive aspects of clinical trial management.”

agClinical 3.3 includes:

• Global Trial Submissions: Important new features that support global trial submissions irrespective of region, country or regulations in support of Clinical Trial Regulation (EU) No 536/2014.
• Enhanced Automation Leads to Increased Efficiency of Clinical Research Associates (CRAs): Enhanced capabilities to automate the monitoring process which will increase the efficiency of Clinical Research Associates (CRAs). Including remote monitoring enhancements, a new mobile monitoring module, Microsoft Outlook integration, e-signed confirmation letter, follow-up letter and workflow based monitoring that publish approved artifacts to eTMF that automates the entire monitoring process.
• RACT Tool: Risk Assessment Categorization Tool as defined by TransCelerate.  This tool enables organizations to develop and implement risk mitigation plans by identifying and entering information for key risk factors resulting in more efficient operations and the ability to monitor risk through key risk indicators.
• Improved Document Management: Advanced functionality and usability improvements to the integrated electronic trial master file (eTMF), unified within agClinical, driving companies to meet and exceed document management obligations.
• Portal with Advanced Functionalities: An advanced Investigator and Site portal that tracks, onboarding, Investigator scoring, key study metrics, enables document sharing, and tracks payment milestones and financial obligations.
• Robust Third-Party Integration: Further enhancements to our already robust third-party integration tools and APIs (application program interface). The enhanced middleware acts as a Clinical Backend as a Service (CBaaS) enabling organizations to integrate with their systems of choice.  Our library of connectors already includes a growing number of EDC (electronic data capture) and document management systems as well as the ability to connect to our own market leading products.

“Clinical trials are highly regulated, complex undertakings,” said Sonia Veluchamy, ArisGlobal Managing Director. “agClinical is recognized by customers and analysts as one of the most functionally-rich CTMS solutions on the market. This newest version further solidifies our position as the leader in this splintered market.”

 About ArisGlobal

ArisGlobal’s cloud-based solutions facilitate global drug development and regulatory compliance in the life sciences and healthcare industries across the entire product life cycle including clinical development, regulatory affairs, safety and pharmacovigilance and medical communications. Hundreds of drug and device manufacturers, CROs and regulatory agencies leverage ArisGlobal’s advanced technology solutions spanning regulatory information management, pharmacovigilance regulatory reporting, medical information and clinical trial management software to make better and more informed decisions, facilitate compliance, reduce risk, and improve operational efficiency. Headquartered in the United States, ArisGlobal has regional offices in Europe, India and Japan. For more information, visit arisglobal.com, or follow ArisGlobal on LinkedIn and Twitter.

The post ArisGlobal Releases agClinical 3.3 appeared first on ArisGlobal.

Data privacy and data retention seem to become more complicated by the day in the realm of medical affairs and pharmacovigilance. I am beginning to think that there really is no solution. With the GDPR (General Data Protection Regulation) coming in 2018 followed by Brexit I trust I am not alone in being a little confused.

In recent meetings with an international pharmaceutical company, I was asked about how our systems cover data privacy.  I thought I had a good and complete answer.  I reassured them that we had implemented country specific data privacy.  We could decide if data privacy was enabled and if it was, we would encrypt all personal data in the database.   We could then set a retention period and ensure that any responses would be essentially unrecoverable after the retention period had passed.  We discussed redaction of data and finally through role-based security we could ensure that users of one company unit could not see any contact data or inquiry history of another unit.

But then a small bombshell was dropped.

Could our medical information systems support product-specific data retention?  In other words, could we keep our data privacy retention period for some products, yet ensure all requests and responses for a specific product are retained indefinitely?

I had to ask why.

The response was actually quite enlightening and questions the notion of when data retention is required.   The response was that if certain products are under legal challenge then it would be required that all responses given for that product are retained as they may become part of ruling on that product.  In other words, we have to be able to retain all inquiries and responses for a particular product.

So in the event of a lawsuit how can we see what advice was given to a patient if we do not retain the data?  We decided there was nothing that could be done prior to the lawsuit but agreed to maintain all data post the law suit…hence the need to remove data privacy from individual products.

So data privacy is simply getting more and more complicated.  Good news for the lawyers!

Contact us to learn how ArisGlobal can help your teams succeed.

The post New Rules Challenging Data Privacy Rentention Processes appeared first on ArisGlobal.

Chicago, Illinois. January 25, 2017

Customers Turn to Cloud Platform for Security, Flexibility and Efficiency

ArisGlobal, a leading provider of integrated, cloud-based software solutions for life sciences companies, has achieved a significant new milestone with more than 70 clients selecting the TotalSafety solution suite for its unique blend of superior safety functionality and software as a service (SaaS) platform delivery.

ARISg is a best-in-class global safety database solution chosen for its robust feature set that reflects ArisGlobal’s more than 25 years of pharmacovigilance, device vigilance, vaccine vigilance and cosmetovigiliance expertise. Customers benefit from ArisGlobal’s vast SaaS experience and flexible deployment models, including a multi-tenant offering that enables seamless and automatic updates, and access to the latest technology capabilities, at no additional cost. Built on ArisGlobal’s cloud platform, ArisGlobal TotalSafety customers have the advantage of leveraging the only cloud-based solution to support critical stages of the drug development life cycle – clinical, safety, regulatory, and medical communications.

The ArisGlobal TotalSafety suite is the only solution that delivers:

• A state-of-the-art platform with a best-in-class user interface
• Compliance with E2B R3 PMDA/Regional variations and an IDMP-ready solution
• Efficiency gains through intelligent process automation and digital technologies (OCR)

“While ArisGlobal remains committed to providing choice and flexibility with our deployment models, today we have half of our ARISg customers on our multi-tenant platform and continue to migrate more customers to this platform so that they can achieve the highest level of efficiency and scale, and enjoy more frequent upgrades that are implemented faster, with minimal business impact, while reducing costly outlays,” says Dr. Krishna Bahadursingh, ArisGlobal’s SVP, Safety and Risk Management.

READ MORE:

• PRESS RELEASE: ArisGlobal Launches TotalSafety 7.3
• WHITEPAPER: agOnDemand Security Framework: Addressing Security Challenges on SaaS

Security and integrity of applications are primary requirements for business-critical applications provided by SaaS. ArisGlobal’s proven SaaS solution has earned a 100% success rate in the security audits performed by more than 200 companies, underscoring the trust in ArisGlobal. To ensure customers meet regulatory compliance and international standards, ArisGlobal’s cloud platform meets guidelines from international authorities such as Health Insurance Portability and Accountability Act (HIPAA) to secure medical information, electronic signature regulations (a component of 21CFR Part 11), ISO information security standard 27001, and nonfinancial reporting controls related to security and confidentiality such as SOC 2.

According to Gartner’s Predicts 2017: Life Science R&D — Digital R&D Gets Smart report: “By 2019, over 75% of life science R&D IT organizations will finally support ‘cloud first’ application strategies.”¹ ArisGlobal’s growing SaaS client base both supports this prediction and echoes its importance.

¹ Gartner Predicts 2017: Life Science R&D — Digital R&D Gets Smart, December 2016

About ArisGlobal

ArisGlobal’s cloud-based solutions support the life sciences and healthcare industries across the entire product life cycle including clinical development, regulatory affairs, pharmacovigilance and medical communications. Hundreds of drug and device manufacturers, CROs and regulatory agencies leverage ArisGlobal’s advanced technology solutions spanning regulatory information management, pharmacovigilance regulatory reporting, medical information and clinical trial management software to make better and more informed decisions, facilitate compliance, reduce risk, and improve operational efficiency. Headquartered in the United States, ArisGlobal has regional offices in Europe, India and Japan. For more information, visit arisglobal.com or follow ArisGlobal on LinkedIn and Twitter.

The post ArisGlobal Announces a Milestone of More Than 70 Top-Tier Life Sciences Customers on the TotalSafety, Cloud-Based Safety Solution Suite appeared first on ArisGlobal.

A preview of DIA’s upcoming Regulatory Conference, where ArisGlobal will unveil its revolutionary regulatory information management system software.

It’s no secret, the main role of any pharmaceutical company’s regulatory affairs (RA) department is to interact with the regulators of different countries throughout the development, registration and marketing phase of the product life cycle – all with the goal of meeting compliance and getting the approval needed so that clinical trials can be conducted and products can be manufactured and safely marketed. And, behind the scenes, RA must ensure that information is collated from different departments in the organization and that the required information is shared with the health authorities. But why do the regulations shifting have to cause such difficulty? Why do pharmaceutical companies end up with such a complicated, hornet’s nest of systems?

Do these challenges sound all-too familiar?

Given this reality, companies need to focus on being ahead of the audits and building internal mechanisms and procedures to ensure that compliance is achieved. Regulatory departments not only have to focus on collecting and sharing information with regulators, but also need to look at the needs of their internal customers.

Not a complete list by any means, but challenges in this area include:

1. An increasing stream of requests for publishing information which is approved
2. Proactive sharing of planned information on upcoming approvals and timelines
3. A more agile approach to sharing the approved information with other departments
4. Interactions with different authorities, requiring preparation for, and managing to, changing regulations such as IDMP
5. Finding an intelligent way to get the participation of affiliates in the regulatory information management process

This all may sound practical – but execution, we all know, is a different thing. But, at ArisGlobal, we have a different take on how to solve this problem.

If these challenges sound familiar, we encourage you to meet us at the DIA Regulatory, Submission, Information and Document Conference (Booth #102) where our regulatory experts will be there to share how our suite of solutions – regulatory information management system software (RIMS) and compliance management (xEVMPD, IDMP) software – integrates compliance with business processes over the entire product management lifecycle.

On February 6, we will be announcing an exciting, innovative regulatory information management solution at this show, so be sure to watch this space for more details.

The post Regulatory Information Management: Solving the Compliance Challenge with a New Approach appeared first on ArisGlobal.

Next-Generation, Cloud-Based Regulatory Information Management System Features Integrated Industry Standard Practices and Advanced IDMP Compliance

Chicago, Illinois, February 6, 2017 — ArisGlobal, a leading provider of integrated, cloud-based software solutions for life sciences, announces LifeSphere™ RIMS, a  multi-tenant cloud-based Regulatory Information Management System (RIMS) that heralds the era of Regulatory Information Management System (RIMS) modernization and innovation with a process and workflow-driven approach for handling all regulatory affairs business processes, using a fully IDMP-compliant data structure. Configurable, role-based workflows, security and other configuration options enable the intuitive user interface to be easily tailored for global, regional and affiliate participation, ensuring a successful enterprise-wide rollout. The Industry Standard Practices-based solution will enable clients to enjoy more frequent upgrades that are implemented faster, with minimal business impact, and reduced costly outlays, achieving global roll-outs in mere weeks.

LifeSphere™ RIMS Solution Overview

“LifeSphere™ RIMS comes with built-in Industry Standard Practices based on our 20 years of regulatory experience and the active participation and feedback from a well-established users community to solve real-life problems,” said Wim Cypers, Senior Vice President, Regulatory. “It’s a uniquely rich and flexible solution that handles all regulatory affairs processes and their variations.”

LifeSphere™ RIMS capabilities:

• The core Regulatory Affairs (RA) tracking modules: Product Registrations, Submission Processes and Agency Interactions provide a single solution for tracking all RA business processes and providing real-time visibility of ongoing submissions, authorizations, commitments, open agency correspondence and upcoming renewals for ensured compliance. Additional modules for Clinical Trial Application Tracking, Global Change Management and Dossier Planning and preparation are planned.
• Compliance module with ISO IDMP and EU extensions coverage provides end-to-end solution for not just submissions compliance but also business benefits of a central product dictionary.
• Comprehensive business process workflow automation enables demand forecasting, submission planning and performance tracking for improved decision making.
• Out-of-the-box interfaces with document management systems and configurable data exchange mechanisms result in improved cross-functional process efficiencies, collaboration, control and visibility of the single source of truth.
• SaaS-based, multi-tenant cloud platform shortens deployment cycle for functional upgrades for constantly evolving regulations, improving agility and responsiveness to changes and minimizing technology risks. On-premise deployment is available, if required.

About ArisGlobal

ArisGlobal’s cloud-based solutions facilitate global drug development and regulatory compliance within the life sciences and healthcare industries. Its cloud platform supports the entire product life cycle including clinical development, regulatory affairs, safety and pharmacovigilance and medical communications. Hundreds of drug and device manufacturers, CROs and regulatory agencies leverage ArisGlobal’s advanced technology solutions spanning regulatory information management, risk evaluation and mitigation strategies, medical information and clinical trial management software to make better and more informed decisions, facilitate compliance, reduce risk, and improve operational efficiency. Headquartered in the United States, ArisGlobal has regional offices in Europe, India and Japan. Visit arisglobal.com, or follow ArisGlobal on LinkedIn and Twitter.

The post ArisGlobal Introduces LifeSphere™ Regulatory Information Management System (RIMS) appeared first on ArisGlobal.

Every one of us at some point will take a medication and likely suffer some sort of adverse reaction. However, while some of us will actually read the product label and identify the possible adverse reactions, only a handful of us will ever report our experiences to the manufacturer. This lack of reporting handcuffs drug manufacturers from fully understanding the safety profile and potential risks of a drug.

As such, companies and regulators are looking for a new approach to solving the challenges of reporting, resulting in a number of initiatives around direct patient reporting that leverage the internet and other communication channels to provide an easy way of submitting adverse event reports.

Of course, while we try to make adverse event reporting software easier for the patient, every company representative, including sales representatives and Medical Science Liaisons (MSLs), also have an obligation to report adverse events in accordance with company SOPs; this requires training to identify and report any potential adverse drug reactions in a timely fashion. The regulatory clock starts ticking the moment the company is aware of an adverse event and is one of the key areas of an inspection and a common reason companies suffer from incomplete or under-reporting. A common reason for under-reporting is partly due to education, but also typical reporting processes have been cumbersome and time consuming, discouraging staff from going through the process. On the other hand, license partners, distributors and healthcare professionals who have an obligation to report are simply looking for solutions to make the reporting process easier and faster.

But there is hope. There are 2.32 billion people using smartphones¹ and 61% using smartphones for mobile banking² , so it is safe to assume that in today’s world, mobile technology is widely accepted. By providing tools based on technology that we are all familiar with, the assumption is that we can increase reporting, awareness and therefore public safety.

And mobile reporting can be made easy. How? By making it simple to report adverse events without the need to register, by providing simple and intuitive reporting on any device, by offering wizard-based entry based on your contact profile, and by giving registered/specialist users access to more information (product leaflets, FAQs, etc.). Clearly nowadays, access needs to be available via smartphones, tablets or PC’s, and should offer off-line support – particularly useful for those annoying times when internet access is not available.

Demand more from your adverse event reporting software today.

Learn more about how to simplify your adverse event reporting process with ArisGlobal’s agReporter™.

¹ https://www.statista.com/statistics/330695/number-of-smartphone-users-worldwide/

The post Adverse Event Reporting Software Gets a New Friend: Mobile appeared first on ArisGlobal.

Time and again you hear the same refrain: “It will be in the next release”. But in the meantime, you’re struggling to cope because you need certain features and functionalities for your clinical trials management system. And right now, the CTMS system that you paid a lot of money for, that was supposed to streamline processes and increase study management productivity, is just not doing what you require of it simply because it’s outdated.

At this point we’d like to dive into something we don’t typically do in our blogs and talk about ourselves. We know this is a little cheeky but sometimes it’s exactly what’s called for – especially when you can see the glaring problems companies face with inadequate CTMS functionality.

Over the last four years ArisGlobal has worked very closely with our clients to ensure that our CTMS platform agClinical meets today’s clinical research needs, with comprehensive and versatile functionalities that will take you seamlessly from study planning and set-up through study conduct and on to study close-out.  We don’t sit back and wait for clients to ask for new features and functionality, or wait for competitors to come out with new functionality first.  We seek continual input from our clients.

So how do we go about this?

Once a year, we organize a two-to-three-day ArisGlobal Client Advisory Board meeting, where we bring together our CTMS users to seek input and guidance on the product road map and future system versions.  We also hold one-on-one workshops with key clients to dive deeper into specific functionality that will help streamline processes and improve end-to-end management of clinical studies.  Our product releases go through months of planning and we validate our new features and functionality with our clients to ensure these updates fit current and future needs.

The latest version of agClinical (3.3) offers improvements around the monitoring process, investigator and site feasibility and selection process, quality management, document management and the investigator portal, on top of new features that cover risk based monitoring, risk assessment and categorization tools, among others. We are confident that agClinical 3.3 will be our most powerful release to date and make agClinical the most effective CTMS system on the market.

Don’t wait around for the “next release” from your current CTMS vendor. Visit our CTMS website for more details on agClinical, including product webinars, datasheets and white papers.  Contact us at info@arisglobal.com for more information on agClinical and to schedule your personalized demonstration of the industry’s most comprehensive Clinical Trial Management System.

The post Promises, promises: Finding a CTMS that gives you what you need – Now! appeared first on ArisGlobal.

We know from our customers that for many medical information teams, being tasked with meeting pharmacovigilance obligations ensuring global compliance, as well as providing up-to-date, consistent and accurate medical information globally, can be a daunting prospect.

While legally obliged to provide scientific services, medical information teams are often overlooked when it comes to the investment support required to deliver a high-performing service. This lack of investment can result in your services lagging in the adoption of the latest innovative technology available.

This means you are having to do more manually; or leverage in-house systems that come with their own set of challenges:

• Manual processes could mean you are spending up to 20 minutes turning around a single medical information request, which decreases productivity and potentially introduces errors in accurate data entry, while delayed response times could negatively impact patient health or run the risk of financial penalties. There is virtually no operational efficiency in the manual-realm and insights are nearly non-existent.
• Gaps in reporting with legacy systems often means it is impossible to produce the actionable intelligence required to demonstrate the contribution of the medical information This often means systems need to be augmented using expensive third party solutions.

What can you, as a medical information professional, demand of any new system?

• An improved user experience – a single system for all medical information functions, designed to support multi-channel communication with Healthcare Professionals, patients, MSLs and medical affairs
• The ability to deliver actionable insights – reporting of metrics, drill-down analytics and easily configured tagging and visualization.
• Enhanced operational efficiency – a uniform platform as well as mobile applications, eliminating navigation or customization of disparate systems.
• Innovation in technology – cognitive computing to automate detection of adverse events.
• The ability to satisfy international data privacy regulations including encryption of personal data and automated redaction.

Tomorrow’s tools are here today

Being able to achieve all this from one medical information system is not as far-fetched as you think: it can be reality. With today’s technological innovations it is possible to support all functions in a single integrated workspace, with many manual processes being automated, delivering value at the same time as controlling costs. Demand more from your systems today.

Connect with our experts and visit ArisGlobal at booth #12 at the upcoming DIA MASC Forum 2017 this March 13-15 in Tucson, Arizona.  Not going to the MASC Forum? Contact us at info@arisglobal.com to arrange an on-site demonstration.

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What Does It Mean to Use Technology Solutions to Solve Your Assessment?

To be clear, we aren’t talking about the “big bang,” long-term approach. We are talking about an immediate, get your organization some fast answers based on what you know – to inform a longer-term, more involved strategy. It’s an approach not often considered, which is why organizations get stuck in “analysis paralysis.” We like to think of it as your secret-weapon.

And the timing can’t be more immediate. EMA is going live with referentials and organizations part of IDMP this year. That has immediate impact on you for continuity on xEVMPD compliance. Delay in IDMP deadlines doubles up the challenge. How do you ensure you continue to submit xEVMPD data in compliance with EMA’s new systems – RMS and OMS, while also leveraging that investment to collect data in an IDMP-compliant fashion in readiness for the changeover and not having to implement changed processes and systems multiple times?

To address this challenge, you need to leverage a solution that enables you to:

• Boost productivity of your regulatory data team by using automation to quickly convert your existing xEVMPD compliant data into a central data hub that is xEVMPD + IDMP compliant
• Ensure compliance by leveraging integration with EMA’s RMS and OMS systems in a system that then help you align and re-code your product information to latest controlled vocabulary and organization information from EMA
• Improve data quality by validating your central product data dictionary against relevant current xEVMPD business rules to ensure all required data is in place
• Create a sustainable maintenance process by making electronic gateway-based submissions to the xEVMPD database in readiness for IDMP where web application-based method is no longer recommended due to sheer volumes and maintenance overhead
• Benefit from reduced rework by re-using the central product dictionary for implementing the IDMP assessment recommendations on an IDMP Pilot with showcase products – old historically approved ones, those with multiple-language labeling, combination kit products, approved using varied group procedures in EU
• Kickstart IDMP data collection with coverage against either iteration 1 or the full IDMP scope by testing central product dictionary against IDMP business rules from ISO and eventually from EMA, FDA, HealthCanada and other agencies
• Use quantitative metrics to benchmark current data quality and identify effort required to augment data to be fully IDMP compliant in order to plan for the resources and process optimization budget for upcoming years

Invest in a technology solution that enables you to clearly visualize the end state as recommended by your assessments, or enables you to effective conduct a pilot to actually assess and benchmark your current data quality and effort to reach To-be state.

Talk to ArisGlobal experts to understand more about this ‘Transformation Enablement via Technology Innovation’ approach and get a demonstration of ArisGlobal’s Global Data Standards Compliance Solution agIDMP that is available on its new LifeSphere™ cloud-based technology platform.

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CHICAGO, IL. APRIL 7, 2017— ArisGlobal, LLC, a global leader in providing cloud-based software solutions for the life sciences, has announced that Pratyusha Pallavi, Product Manager for Regulatory, will present at the eRegulatory Summit to be held in Madrid from April 25 to 27, 2017, on the topic “Regulatory 2020: Technology-Fueled Business Transformation.”

The presentation, scheduled for April 25, 12:00-12:30 p.m., will explore the implications that broader industry drivers – pricing wars, real-time metrics during audits, the digital supply chain, and disruptive technologies – have on regulatory affairs. Pratyusha will identify key success criteria and approaches to develop the 2020 regulatory information management solution landscape that can leverage the emerging business drivers to enable a successful transformation.

“While regulatory affairs might currently wonder why major technology changes taking place across R&D should affect them, the reality is any transformation is only successful if it is managed organization wide and is aligned to the overall business strategy,” Pratyusha says. “All cross-functional departments need to work more collaboratively to successfully navigate through this disruptive technology phase that the life sciences industry faces in the next 5 to 10 years.”

In addition to Pratyusha’s presentation, ArisGlobal will also be exhibiting at the eRegulatory Summit (Stand #20) and is a sponsor of the event. The event will bring together regulatory professionals to explore developments in RIM, Identification of Medicinal Products (IDMP), and the electronic Common Technical Document (eCTD). Attendees are invited to visit Pratyusha and attending ArisGlobal staff to learn about or request a demo of LifeSphere RIMS, the cloud-Based regulatory information management system (RIMS) with full IDMP compliance.

About ArisGlobal

ArisGlobal’s cloud-based solutions facilitate global drug development and regulatory compliance within the life sciences and healthcare industries. Its cloud platform supports the entire product life cycle including clinical development, regulatory affairs, pharmacovigilance and medical communications. Hundreds of drug and device manufacturers, CROs and regulatory agencies leverage ArisGlobal’s advanced technology solutions spanning regulatory information management, risk evaluation and mitigation strategies, medical information and clinical trial management software to make better and more informed decisions, facilitate compliance, reduce risk, and improve operational efficiency. Headquartered in the United States, ArisGlobal has regional offices in Europe, India and Japan. Visit arisglobal.com or follow us via Twitter, LinkedIn or Facebook.

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Regulatory affairs departments are accustomed – and even open — to change and adapting their technology and processes in response to compliance and business pressures. Typically, regulatory affairs leaders respond to such drivers as “how do we improve efficiency?,” “how do we speed the process to improve time to market?,” and “what do we need to do to get the right information from affiliates on time?”

But in an age of heightened collaboration combined with a push for greater harmonization around the way products are developed, manufactured, delivered, marketed, and reimbursed, regulatory affairs is having to consider wider business drivers.

That’s not to say that efficiency, time to approval, and affiliate management aren’t important, but rather that these are operational issues, whereas business drivers extend far beyond into strategic business matters.

Regulatory Affairs: Prepare for Disruption

It’s clear now that for the regulatory affairs industry to transform and respond to disruptive innovation, it must move away from point solutions and start to respond – from a process and technology point of view – to the larger drivers the entire company is facing. Those drivers have potentially huge ramifications for industry, including pricing pressures, audit expectations, managing the supply chain, and the transfer of documentation across the enterprise and beyond.

Equally, those drivers extend into new ways of doing business and interacting: the Internet of Things, social media, artificial intelligence, and blockchain technologies.

While regulatory affairs may well question how many of these issues affect them, the reality is in today’s more connected environment they soon will, and progressive organizations should prepare now by building the 2020 regulatory information management (RIM) technology landscape to successfully manage the transformation. Quite simply, regulatory – and indeed any department – can’t go it alone, they need to work collaboratively to tackle the disruption that can potentially advance innovation.

Over the next few weeks we’ll explore the themes of cross-functional business drivers and next-generation digital trends, how these are impacting regulatory affairs, and technology responses affecting the regulatory compliance management system that are needed to achieve future success.

Join Pratyusha Pallavi, Product Manager – Regulatory, at the eRegulatory Summit, April 25-27 in Madrid, where she’ll be presenting on the topic of Regulatory 2020: Technology-Fueled Business Transformation, and where ArisGlobal will be also exhibiting.

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CAMBRIDGE, MA. March 16, 2017— Clinical Research IO (CRIO), a Cambridge-based technology company that has developed the first eSource system built and marketed directly to clinical research sites, announced today that it will collaborate with ArisGlobal to streamline clinical research.

CRIO’s system replaces the paper forms used at many research sites with an interactive web and tablet-based application. Using the system, researchers are able to configure eSource templates, and capture data quickly and accurately. By digitizing the collection of source data by investigators and integrating with other solutions, the company offers sponsors improved data quality and streamlined workflows.

Under the collaboration effort between CRIO and ArisGlobal, data captured electronically in CRIO will integrate with ArisGlobal’s agCapture, an electronic data capture system, and its integrated CTMS solution, thus eliminating double data entry and source data verification, two activities that consume up to 20% of the total time spent on a clinical trial.

“This collaboration is an excellent example of the cross-vendor collaboration required to resolve challenges in clinical research,” said Phuc Truong, co-founder of CRIO. “With this integration, we can give principal investigators and their staff an extremely user-friendly interface to collect data in way that’s consistent with their workflows, and ArisGlobal can deliver their life science sponsors immediate access to accurate data that does not need source verification.”

“Integration with Clinical Research IO further ours mission of offering life sciences companies a full lifecycle solution to enhance data quality and streamline operations,” said David Laky, Vice President of ArisGlobal – Clinical Solutions. “Many of our clients are looking for a solution to take out cost and time while enhancing data quality, and through this collaboration, we can deliver exactly that solution.”

CRIO is the leading eSource solution for clinical research sites. Since its launch in September, 2016, it has signed up 50 research sites, and is now deployed on over 60 studies. For more information, visit www.clinicalresearch.io.

ArisGlobal’s cloud-based solutions facilitate global drug development and regulatory compliance within the life sciences and healthcare industries. Its cloud platform supports the entire product life cycle including clinical development, regulatory affairs, safety and pharmacovigilance and medical communications. Visit arisglobal.com, or follow ArisGlobal on LinkedIn and Twitter.

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