agEncoder is a central coding solution that seamlessly integrates with ARISg, other safety case handling systems including Oracle Argus™, and other third-party tools such as clinical data management/EDC systems. With standard APIs and webservices, it receives verbatim (reported) terms from any compatible source system and performs auto-coding against the specified dictionary using advanced coding algorithms and defined synonyms, returning the coded terms back to the source. agEncoder supports adverse event term dictionaries (MedDRA) and product dictionaries (WHO DDE, Japanese Drug Dictionary) facilitating the management of each dictionary including upgrade/impact analysis and recoding.
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REGULATORY COMPLIANCE, INCREASED PRODUCTIVITY, QUALITY MANAGEMENT, AND LOWER TOTAL COST OF OWNERSHIP HIGHLIGHT PLATFORM UPGRADES
Chicago, Illinois, October 4, 2016 — ArisGlobal announces the launch of TotalSafety 7.3, the latest enhancement to its comprehensive safety suite. Building upon industry-leading best practices, the fully cloud- and Single Application Instance (SAI)-based platform continues to meet the compliance requirements stipulated in the most recent pharmacovigilance and device vigilance regulations, while incorporating innovative technical and functional improvements.
READ MORE: The Big Picture in Safety, a Four-Part Blog Series: Part 1 | Part 2 | Part 3 | Part 4
“We actively listened to client feedback, with a specific focus on their customer experience,” said Dr. Krishna Bahadursingh, ArisGlobal’s SVP, Safety and Risk Management. “TotalSafety 7.3’s reliability and rich functionality is now accompanied by a streamlined view that we’re confident will immediately enhance our clients’ productivity and efficiency.”
Initial market results have shown productivity increases of up to 20% with the latest release. Features including a new interface empowering users to create custom views, improved follow-up data reconciliation, and workflows specifically tailored to their business needs help to fuel these gains.
TotalSafety 7.3 is also a leader in compliance – built to meet all current, published IDMP requirements, the solution is uniquely positioned and can be quickly adapted when final guidelines are announced in early-2017. With the PMDA having begun accepting E2B(R3) formatted files in 2016, the EMA requirement for Marketing Authorization Holders to be able to download and import E2B(R3) files in November 2017, and the mandatory cut-overs to the E2B(R3) formats in 2018, the newest release comes at an especially critical juncture. Having a comprehensive platform that can anticipate and navigate the regulatory changes ahead of time will be instrumental in providing operational acumen and agility for life sciences companies.
“Deploying the preeminent, end-to-end life sciences safety tool allows clients to leverage ArisGlobal’s 30+ years of regulatory compliance experience,” said Managing Director Sonia Veluchamy. “TotalSafety 7.3 helps ensure that our clients are prepared for, if not ahead of, the ever-changing industry requirements.”
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 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.
By Phillip Strickland, Strategic Account Manager, Clinical Solutions
In an article by Outsourcing Pharma earlier this year, it was reported that the global CRO market is expected to top $45 billion by the year 2022. That article attributes this growth to increased R&D spending, patent expirations, more CRO outsourcing and also government agencies turning to CRO organizations to conduct more clinical trials. A more recent article, also from Outsourcing Pharma, references research performed by KMPG that estimates that the top ten CROs represent more than half of the total CRO market. With estimates as high as 1,500 or more CROs worldwide, that doesn’t leave much for those CROs outside of the top 10 to share. With the trend of today’s CRO environment being one in which the large CROs continue to get larger while the smaller CROs get smaller, isn’t it time to level the playing field and give smaller CROs an equal opportunity at growth?
One primary area that can help small-to-medium sized CROs compete is with having access to the right set of eClinical technology tools. Long gone are the days of paper trials, and multiple eClinical technologies are often utilized in a trial today, across various devices from PCs and laptops, to mobile devices such as smartphones, tablets and wearables. Smaller CROs need access to validated technologies that are affordable and that can be employed when and where needed.
ArisGlobal is introducing our new “Pay-As-You-Grow Partner Program.” This program will give smaller CROs an affordable eClinical tool set needed to compete with the big CROs. Choose the software modules needed now, add more as you grow. With study-by-study pricing and the ability to configure the solutions to meet your processes, this cloud-based eClinical tool set will give smaller CROs the agility and technology of a top ten CRO, but at a much lower cost. Reduce time and cost-of-study deployments, and enjoy better visibility into real-time, quality data that will give the smaller CRO the operational improvements necessary to compete in today’s clinical research environment.
Register for our free webinar, “Learn How CROs Can Boost Profits and Productivity” this Tuesday, October 11, 2016 at 10:00 AM EDT. During this webinar, our panelists will review the key challenges faced by small-to-medium sized CROs today, discuss ArisGlobal’s eClinical solutions and introduce our new “Pay-As-You-Grow Partner Program.” Learn how smaller CROs can level the playing field with the larger CROs by deploying the right eClinical tool set for a fraction of the cost previously available.
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By Richard Jenkins Image may be NSFW. Clik here to view.
With about a quarter of the life sciences market believed to be using Cerner’s dsNavigator coding tool, the decision to pull the solution from the market raises understandable concern and many questions about what the priorities should be when seeking a replacement.
As I discussed in my recent blog, having a coding tool is essential for meeting compliance requirements. Hence, companies using dsNavigator will need to transition to another tool – and sooner rather than later. Already reports of functional gaps in the DSNavigator tool that won’t be addressed are cropping up.
There are other issues to consider that have substantial implications. For example, any updates to the MedDRA (Medical Dictionary for Regulatory Activities) hierarchy itself will not be reflected in the tool as Cerner is not doing any further updates. Nor will Cerner support integration with any new systems.
Before selecting a replacement tool, companies should take advantage of the transition period to ask some pertinent questions.
Thinking Big
Life sciences companies may use a number of dictionaries, so it’s important that your tool handles dictionary version management and can manage multiple dictionaries, including maintaining a synonym list for each dictionary. The ability to migrate your synonym list may be another priority, and since this can be time-consuming, you need to know that your tool – and vendor – can adapt to your needs.
An important capability for a coding tool is automation, specifically as it applies to auto-coding against the synonym list or against the dictionary. Can the tool perform advanced coding algorithms and review synonyms before they are added to the synonym list?
To Integrate or Not to Integrate
A key question in selecting a coding tool is, will it be used as a standalone or integrated tool? If the latter, you’ll need to decide with which systems you want to integrate your coding tool. Is it safety, is it clinical data management systems, or both? Then you need to decide how that integration will happen. That’s a technical issue that will depend on your web service. Some companies use Simple Object Access Protocol (SOAP) web services and others use Representational State Transfer (REST) web services. You would want to know that your vendor is able to modify the web services to integrate with your SOAP or REST web service.
Careful planning needs to go into the technical details of integrating what data gets passed back and forth: is it just a coded term, is it the hierarchy, is it other general attributes such as indication, or study-specific data points coming from a data management system? What other terms and attributes are being brought in? You also need to consider whether you’ll be using multiple versions of MedDRA, and if you’ll require multiple versions to be loaded and context-specified for a particular study.
Emphasis on Partnership
When you’re moving to a new tool, it’s important to know whether your vendor will listen to what you need and will adapt as your needs grow and evolve. Will they modify their roadmap to respond to client needs, market needs, compliance developments, and so on? Does your provider have ongoing communities of interest (user groups, for example) with their clients to solicit input?
What is the level of involvement of the tool developer? For example, if they outsource implementation to a third party, how much support can you expect to receive if issues arise?
Preparing to Switch
With a switch from dsNavigator a fast-approaching requirement, now is the time to have a clear idea of what you want and need from your coding tool.
Having a good coding tool to address priorities such as automation – flagging instances where there is no match between a reported event and the synonym list – and potential inconsistencies with MedDRA updates are just some key considerations, along with ensuring a trusted partnership.
As cited in a recent blog, the Contract Research Organization (CRO) market is rapidly expanding. The flip side of this increased demand is that many CRO’s large and small are struggling to support what sponsors want while maintaining profit margins and curbing costs.
While the challenges vary, CRO’s on a recent webinar reported three common areas where they’re often most challenged:
A lack of flexible reporting,
Limited access to data to support transparency, and
Inadequate resources to implement and manage eClinical
Further, CRO’s need clinical trial management software (CTMS) that are agile, scalable and flexible as reported on the same webinar. Participants were asked what top three attributes they look for in a CTMS, and the number one response by an overwhelming majority was scalable functionality.
This shouldn’t come as a surprise since CRO workloads fluctuate based on how many studies they’re conducting, what phase trials they’re supporting, among other factors. Undoubtedly, the key to success for any CRO is having a scalable, agile and flexible solution that can meet their demands and keep their sponsors happy in a Pay-As-You-Grow approach.
Image may be NSFW. Clik here to view. Deploying a regulatory submissions management system is a critical challenge for many pharmaceutical companies as they wrestle with the vast amount of information exchanged within their own department, affiliates and regulatory authorities.
The process is often manual, labor-intensive, error-prone and inefficient – all of which can lead to:
Delayed time to market
Lost revenue
Failed filings
In addition to meeting today’s regulatory information management challenges, regulatory affairs professionals should also be thinking longer-term with initiatives like IDMP on the horizon. Are you ready?
Register Now for an upcoming webinar where you can uncover insights and best practices in closing regulatory submissions gaps – and help ensure you’re future-ready!
In an increasingly global environment, drug safety departments have been making significant investments in implementing common processes and systems to support operations in all regions. This may entail deploying local tracking systems for initial receipt and final submission, integrated with a centralized core case processing system. With the wider user base and generally increasing year-to-year case volumes, the focus of these systems is on efficiencies of single case processing and retrieval. However, there are multiple business needs requiring fast reporting and analysis spanning cumulative safety data. In addition to the basic regulatory need for compilation of periodic safety update report listings, companies need to analyze consolidated processing data across operating units to monitor compliance or look at metrics to effect resource and operational efficiencies. Finally, companies also need a platform for maintaining other available large-pool safety data from external sources to utilize in signal detection and benefit-risk management activities.
Please sign up below to view this webinar which looks at the advantages of implementing an optimized data warehouse platform for safety reporting and analytics that can address these different business needs.
Achieving a holistic view of drug safety operations can be challenging given that the underlying data required to do so typically resides in multiple systems across the organization.
Using agHub, life science companies and CROs can leverage the drug safety data that resides throughout an organization, across multiple databases or in other external data sources, such as clinical trial or product dictionaries
Please sign up below to view this webinar and know how agHub allows your safety compliance officers to efficiently manage their resources and take the necessary steps to mitigate risk, avoid business disruption, improve relationships with regulators and avoid the possibility of fines and other costly liabilities.
Please sign up below to view this webinar which looks at the advantages of implementing an optimized data warehouse platform for safety reporting and analytics that can address these different business needs.
ARISg, the world’s leading pharmacovigilance and clinical safety system, has a rich set of features that help life sciences organizations comply with drug safety regulations across the globe. The superior architecture of ARISg promotes flexibility, adaptability, and openness. ARISg supports multi-tenancy, which means a company only needs a single ARISg instance to support the safety system needs of all of its affliates / customers. This paper explains in detail how ARISg leverages its multi-tenancy architecture and describes other unique features that provide tangible business benefits for CROs and life sciences organizations.
An integrated safety and pharmacovigilance system with worldwide business processes helps companies realize significant productivity benefits. This position paper summarizes Aris Global’s Total Safety global solution for companies that are either headquartered in Japan or have Japanese affiliates and focuses on the key benefits of deploying a single safety and pharmacovigilance system.
Aris Global has made great strides in delivering on the vision for achieving end-to-end paperless safety. This paper discusses the challenges that headquarters have in capturing all inbound safety issues, tracking compliance at each affiliate and partner, ensuring data quality of received reports, and performing effective follow-up tracking with appropriate documentary evidence. You are introduced to agXchange IRT and OST, that enable companies to deploy cost-effective, end-to-end safety item tracking from receipt to submission.
Nearly all companies worthy of mention have received a letter containing one or several of these notifications:
“You do not consistently report Adverse Drug Experiences (ADEs) within 15 days of initial notification…”
“You do not have adequate written procedures for managing from all sources…”
“You have failed to maintain records of all ADE’s for the prescribed time periods…”
This is often followed by a fire-drill response and attempts to mitigate the potential fines, sanctions and/or reprimands. The fact is, advertise event reporting is often run as a triage process: stop the bleeding, stabilize and try to return to normalcy.
The root cause of the problem is often the lack of an integrated Inbound Receipt and Triage (IRT) system. Despite firms’ desire to capture and process all adverse events in a proper and timely fashion, many rely on a manual (paper- or fax-based) system instead of an electronic, automated IRT workflow for Safety information processing worldwide.
The fines, loss of focus, people and time resources from this ungainly process collectively cost the world’s major pharmaceutical
companies close to $1 billion a year. The impact on those who are least able to bear it — Small & Medium-Sized Enterprises (SME’s) — is even greater.
Complete this form to gain immediate access to this white paper:
Over the years, life sciences organizations have made very few changes to their pharmacovigilance systems resulting in long upgrade cycles. This leads to difficulty in keeping up with regulations and technical evolution and more importantly makes the upgrade process lengthy, expensive and disruptive. To add, it also has an impact on cost of maintenance of legacy systems. In this on-demand webinar, we will discuss how continuous improvement of pharmacovigilance systems will act as a driver for upgrade efficiency and cost savings. As part of this discussion, we will talk about how ArisGlobal actively works with its customers on reducing the update and upgrade efforts. This allows the customers to better plan improvements, reduce the cost of improvements, deliver improvements on a continuous basis and deliver higher value to business.
Adoption of the E2B (R3) electronic submission format for individual case safety reports (ICSRs) will require a significant effort from drug safety departments. E2B (R3) introduces a number of new concepts which would necessitate changes to the scope and granularity of the safety case data collected. In addition, companies will have to enable processes and PV systems to maintain coexistence of E2B (R2) and (R3) for the transition period. Companies will also need a strategy around implementing the new ISO IDMP (Identification of Medicinal Products) standard for their products, to allow identifying products and substances in the E2B (R3) message using this new standard.
With potential adoption by regulatory authorities becoming a reality soon, businesses need to start planning their journey toward E2B (R3) compliance at the earliest. With planning, companies may also utilize this opportunity to also review processes and systems to achieve further efficiencies in their safety processing.
Please sign up below to view this webinar to understand the various challenges, opportunities and planning needed as you embark on this compliance journey.
E2B (R3) compliance has multiple implications and triggers significant challenges for life sciences organizations at multiple levels: functional, technical and business. With EMA setting a timeline of July 2016 for E2B (R3) compliance, it’s high time, companies started to plan for the same.
Sign up now for instant access to our on-demand webcast from industry expert and learn what you need to know today. The webinar includes:
• Overview of the standard
• Impact and changes
• Implementation guideline
• Charting the journey
Signup now and start planning for the E2B (R3) compliance.
In 2013, the new E2B (R3) reporting guidance for transmission of Individual Case Safety Reports based on Health Level-7 (HL7) messaging protocol to outdated the existing E2B (R2) protocol. A clear advantage provided by E2B (R3) over E2B (R2) is capturing of more data with increased granularity and frequency. While the ICH guideline describes the harmonized core set of ICH E2B (R3) data elements and business rules, it also includes many non-harmonized regional data elements to support electronic Vaccine Adverse Event Reporting System (eVAERS), which the FDA has adopted for electronic reporting for Vaccines.
Collection of adverse event information on medical devices is mandated by Medical Device Reporting (MDR) requirements. The electronic Medical Device Reporting (eMDR) provides the capability for electronic data entry and processing of medical device adverse event reports. This utilizes Health Level Seven (HL7) Individual Case Safety Report (ICSR) standard to receive medical device adverse events (MDRs).
This webinar will help to:
• Understand the concept and review the basic elements and standards required for electronic reporting through E2B (R3), eVAERS and eMDR
• Discuss on the regional specification of E2B (R3), eVAERS, eMDR
• Explain the impact of the guidelines on overall business process
Recent webinar, polls reveal challenges and future plans in regulatory submission processes
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Deploying an efficient regulatory submissions management system is a challenge for many pharmaceutical companies as they wrestle with the vast amount of information exchanged within their own departments, affiliates and regulatory authorities. The process is often manual, labor-intensive, error-prone and inefficient – all of which can lead to delayed time to market, lost revenue and failed filing processes.
Despite having purchased solutions to help with the submissions process, the last leg tends to remain a largely manual process. Current systems do not address the electronic submission process to the health authorities, leaving companies stuck transmitting information in the required format(s) while maintaining an audit trail throughout the process.
Top Challenges With Regulatory Submissions
It should come as no surprise that, on a recent webinar, many regulatory professionals cited time spent managing submissions, having a consolidated repository for their product portfolio, and collaboration with other groups as their top challenges:
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What Are Your Plans for Addressing Future Challenges?
Further, while many recognize the need to improve their submissions processes, few have taken action to future-proof their submissions processes for upcoming initiatives like IDMP – and in fact, none of the respondents have implemented a solution to address future regulatory submissions processes:
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To gain more insights on regulatory submission challenges from insights from industy experts – including a Top 10 Pharma executive – watch the “Closing the Gaps in Regulatory Submission Processes” webinar today!
Deploying an efficient regulatory submissions management system poses various challenges, including juggling vast amounts of information from disparate sources.
Please fill in the below information to View the Webinar:
Pharmacovigilance and drug safety departments in life sciences companies must do more with less yet meet or exceed the same levels of quality and compliance. As case volumes and complexities increase, many safety departments simply cannot survive if they continue with their current risk evaluation and mitigation strategies.
Further, regulators exercising ‘zero tolerance’ policies expect pharmaceutical companies to have sound and compliant safety systems in place as the emphasis has shifted to signal detection, risk prevention, assessment and minimization as patient safety is paramount.
To help address these challenges, attend the upcoming webinar as experts including industry leader Dr. Krishna Bahadursingh will provide insights both as a former executive from a Top-10 pharma and the business leader for ArisGlobal’s world-renown safety solutions.
Register today to learn how drug safety systems need to evolve to manage existing challenges in safety – and how resource-strapped teams can help ensure compliance and prevent risk by leveraging technology.
