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This is the first in a two-part blog series that examines the key areas that pharmaceutical companies, service providers and solution providers should focus on as technology advancements continue to transform drug safety for the better.

Together with advanced computing technologies like artificial intelligence in pharmacovigilance systems and processes, the life sciences industry as we currently know it is facing digital disruption that will create major transformation for the better…and more changes are on the horizon. These changes represent a disruptive shift to the traditional manner of processing data. In particular, Drug Safety/Pharmacovigilance is going through a paradigm shift, as technology developers are incorporating modern infrastructure, as well as robotic and cognitive automation capabilities, to redefine the end-to-end activities in safety case processing.

Pharmaceutical Companies & Service Providers: How well are you prepared for the change?

The huge potential to alleviate the impact of increasing adverse event case volumes is driving pharmaceutical companies to challenge internal processes to incorporate these technological advancements. For service providers (CROs/KPOs/BPOs), who are under constant pressure to deliver annual cost reductions, these technology advancements can be the holy grail to increasing productivity while reducing costs.  With all these moving parts, it is imperative that the overall industry-preparedness level, including those of regulators, be raised.

Below are some of the key areas that pharmacovigilance departments and service providers should focus on to achieve to ensure preparedness for this change:

• Aim to minimize costs associated with current safety database infrastructure, including maintenance costs, by capitalizing on shifts to multi-tenant and SaaS models
• Move away from highly customized processes and adopt industry-leading, highly efficient, standardized processes, eliminating the burden on internal teams to maintain complicated customizations
• Implement forward-thinking processes and practices that take automation into account, and can scale to handle changing case volumes
• Understand the regulatory perspective of how cognitive computing and automation will be governed
• Train existing resources and provide them with an updated skill set to better prepare them for revised job responsibilities as intelligent automation will displace previous manual tasks

Technology Solution Providers:  Recalibrating the Client-Vendor Model

Leading Safety solution providers, like ArisGlobal, who are incorporating state-of the-art technologies and software development methodologies, will be the key drivers of this transformation. Just like pharmaceutical companies and service providers, technology solution providers will need to recalibrate the traditional client-vendor model. Their focus should be on:

• Creative pricing models that reflect evolving market demands: working closely with pharmaceutical companies to build a comprehensive return on investment (RoI) model as a result of automation within Pharmacovigilance processes
• Reduction in implementation and upgrade cycle times
• Addition of change management and organizational readiness services as key focus areas
• Leading the drive from customized to standardized workflows and processes, etc.

In our concluding blog in this series, to be published in late March, we will share examples of use cases to showcase how these advanced technologies are already transforming drug safety as we know it.

Using ArisGlobal’s LifeSphere MultiVigilance as an example, we will share how automation functionalities built with combination of artificial intelligence (AI) with robotic process automation (RPA) can help organizations streamline case processing, substantially reducing manual e­ffort to give companies cost savings of up to 50%, realized by higher data quality and compliance.

This is the second in a two-part blog series that examines the key areas that pharmaceutical companies, service providers, and solution providers should focus on as technology advancements continue to transform drug safety for the future.

Read our first blog, “Are You Ready for the New Era of Drug Safety” for background information on this discussion.

Clinical safety is changing from a reactive role to a strategic role throughout the product lifecycle. This requires organizational changes and oversight. As case volumes increase, and tougher regulations are introduced that call for more stringent oversight by health authorities, the days of using those circumstances as a justification to request more staff to mitigate the increased workload of collecting and processing data are most likely gone. Today’s reality is one where pharmacovigilance/drug safety departments in life sciences companies are required to do more with less.  

To succeed, organizational readiness now requires a mindset and plan to manage existing challenges and prepare for the unknown ones around the corner.  As shared in our March 14 blog, there are many technology advancements – artificial intelligence (AI), natural language processing (NLP), deep learning, multi-tenant cloud, chat bots and more – that are or will disrupt the status quo way of thinking and working.

While artificial intelligence (AI) and natural language processing (NLP) will streamline adverse event case reporting for the better, providing up to an 80% increase in efficiency in case intake and data entry, that doesn’t mean that  jobs and livelihoods will be lost as a result. Instead, as automation handles repetitive and routine manual tasks, safety departments can use this digital disruption to retool their workforce to address higher order activities such as case assessment, signal detection and risk management activities.

To get ready for the changes ahead, three key areas of focus need to be planned for and addressed:

Change Management

Without question, digital disruption will have an impact on your safety team, as any change means a new and different way of doing something. A Change Management plan must be implemented hand in hand with any proposed change to technology and supporting processes. Gaining the buy-in of your staff is critical, so spend time clearly articulating the purpose of the change and then connect that with their daily tasks and activities. Gain insight from colleagues in other companies who may be ahead of you in this transformation journey, learn from their mistakes and successes, and then adapt that insight to your organization’s culture.

Safety system/database solution providers such as ArisGlobal have created focused groups of life sciences companies that can discuss technological advances, prioritize critical business challenges and make quick decisions to address them with technology. This allows organizations to discuss change management planning in the context of process changes due to technology enablement.

Training

Deploying new software into an organization or department stands a better chance for success when proper training is part of the planned rollout. Helping your staff understand how the new technology / software will improve their work and productivity, and contribute to improved patient outcomes is a good start, but it takes time for people to adjust to changes in their daily work routine. Letting go of familiar processes and learning new behaviors can be hard for some, so giving your staff the time to get properly trained by professional trainers is an essential piece of any plan involving the disruptive change agents discussed in our previous blog. Of course, training and employee success will be achieved faster if the software vendor has created a comprehensive training curriculum leveraging a mix of interactive online training materials and instructor-led sessions that can be delivered in an agile manner, coordinated with the introduction of new processes.  

Learning Development

Finally, building a company that can respond positively to change requires a learning and development strategy built around a framework and plan for re-tooling the capabilities and skills of your team to meet your organization’s business strategy. As LifeSphere MultiVigilance’s automation capabilities help eliminate manual data entry and streamline processes, it’s important to help your staff recognize they will have time for more value-added responsibilities that will make them better qualified to meet the challenges ahead. By providing them the learning and development necessary to undertake what will become new areas of personal growth — case assessment, signal detection and risk management activities – your pharmacovigilance department stands a stronger chance of meeting the demands for the new era of drug safety.

The New Era of PV is upon us and novel technologies have the potential to transform drug development processes, automating routine and repetitive manual tasks. With these changes, highly-trained staff can focus on higher value work, consequently replacing certain transactional roles. Have questions on this topic?  We invite you to learn more by viewing our on-demand webcast, “Practical Use Cases of Automation in Pharmacovigilance and Regulatory to Achieve End-to-End Productivity.”

Please send any comments and questions regarding this blog to info@arisglobal.com.

Software systems supported by a cloud-based infrastructure have become a mainstay in today’s global economy. In fact, many organizations have been leveraging the use of cloud technology for well over a decade. Since its inception, cloud technology has continued to evolve and improve, and today Amazon Web Services (AWS) and others offers a cloud infrastructure platform that enables solution providers to deploy and manage their solutions in an orderly, compliant, and efficient manner.

ArisGlobal, part of the more cautious and highly regulated life sciences industry, recognized the benefits of this reality a long time ago. We were one of the very first life sciences solution vendors to deliver software-as-a-service (SaaS-based) could solutions. Today, that momentum continues as we go “all-in on AWS” by moving our entire cloud infrastructure to the AWS platform, the most sophisticated and mature cloud in the industry. This move benefits both ArisGlobal and to our customers.

For ArisGlobal, we can now provide a globally unified, standardized solution on the AWS infrastructure-as-a-service (IaaS) platform to drive compliance and enhance the experiences of all our customers. The entire LifeSphere® platform is now powered by the AWS Cloud, and currently more than 85 of ArisGlobal’s 200+ customers have been migrated, with more to quickly follow.

For our customers, there are several important benefits. These include:

• Reduced Operating Costs. Measured in both time and money, on-premise computing requires significantly greater preparation, as compared to cloud computing. ArisGlobal customers migrating to the cloud save significantly on the initial setup cost, and ongoing maintenance is taken care of by ArisGlobal. All support, maintenance and incident responses are managed by ArisGlobal, which further reduces the total cost of ownership for ArisGlobal customers.
• Quick On-Boarding and Deployment. AWS gives us a highly reliable global infrastructure, security, and a broad portfolio of cloud services to host the LifeSphere multi-tenant cloud platform with industry standard configurations. Because of this, customers can be deployed and onboard with increased speed.
• Unmatched Security. ArisGlobal has robust security framework in place. Our information security is compliant with the industry leading information security standards and regulations like ISO 27001, SOC 2, GDPR & HIPAA. AWS Cloud is also compliant with all the security and privacy standards along with all global regulations.

  In AWS, ArisGlobal has leveraged key security features like Cloud Watch and Cloud trail to closely monitor the traffic and actions performed at API level. Critical functions like Identity & Access Management, Encryption, Log management is also managed by using features of AWS. Capabilities like AWS Guard Duty, which is a Machine Learning based tool, which continuously monitors threats and add industry intelligence to the alerts it generates is used by ArisGlobal for 24/7 monitoring; along with AWS Inspector, which is a vulnerability detection tool. To ensure end to end cyber security, ArisGlobal has deployed an end to end EDR solution called Trend Micro Deep Security.

  At ArisGlobal, all products are tested for security vulnerabilities using IBM AppScan tool and manual code review, following OWASP Top10 guidelines and NIST standards to ensure Confidentiality, Integrity and Availability of data.

• High Reliability & Availability. On the AWS Cloud, ArisGlobal operates across almost all the 20 AWS Regions and AWS’s 61 Availability Zones. (AZs are essentially the physical data centers of AWS, whereas a Region is a collection of availability zones that are geographically located close to one other.) AWS provides ArisGlobal with prompt and completely on-demand infrastructure provisioning with hours, along with built-in redundancies, all managed by AWS. In addition, ArisGlobal can now schedule and automate application backups, scale up databases in minutes by changing instance type, and have instances automatically moved to a healthy infrastructure in less than 15 minutes in case of a downtime, giving customers improved resiliency and availability. In comparison, companies choosing to stay with on-premise computing, will need to negotiate and purchase more hardware and software as demand requires, and those purchases are permanent.
• Faster Innovation & Improved Customer Satisfaction. With ArisGlobal’s move to the AWS cloud, we can continue to bring new offerings to the market even faster and with greater efficiency. Every instance of the LifeSphere platform, which covers all primary functions of the product lifecycle – clinical development, regulatory, safety, and medical affairs – will be powered by AWS. These instances will also be powered by NAVA, ArisGlobal’s proprietary cognitive computing engine for process automation, to drive significant efficiency gains.

ArisGlobal recognizes that our customers rely on our technology platform to help bring their therapies to market faster and with greater cost effectiveness. With our continued focus on automating core business processes, and our latest move to AWS Cloud, that goal is being achieved .

Have any questions? Please email us at info@arisglobal.com.

It is with great excitement that we announce that Nordic Capital has entered into a definitive agreement to acquire ArisGlobal. Six months ago, ArisGlobal set out on a mission to find a large investor to support our rapid growth moving forward. This was a carefully administered process that required us to engage and vet a number of top healthcare investors as we searched for the best partner for ArisGlobal. Today, I am pleased to inform you that we have found the right one.

Our firm traces its roots back to 1987, when our founder, Deepak Abbhi, pioneered the development of a first-in-industry adverse event management system that would help life sciences firms automate their mission critical global pharmacovigilance functions for patient safety and regulatory compliance. Over these 32 years, we have built a sustainable and growing business that thrives on its partnerships with many life sciences companies and regulatory agencies. These customer relationships, some lasting decades, have allowed us to become a leading healthcare technology company with over 1200 employees across an expansive global footprint.

Today, we are embarking on a new chapter that will accelerate our ability to achieve our mission of being the leading provider of SaaS solutions for pharmacovigilance, regulatory affairs, medical affairs and clinical development. As our two companies began joint discussions, the possibilities of what we might do with Nordic Capital became very compelling. Nordic Capital, through their investment in ERT, a leading clinical technology solutions provider, has a proven life sciences track record and we share a closely aligned vision for the future of the industry. The acquisition gives us immediate access to deep resources and expert guidance that will help us in our journey. For all the reasons mentioned above, our founder, myself, our Board of Directors, and management team all came to believe that the best way – the most exciting way forward for ArisGlobal and our clients – was to join forces with Nordic Capital.

Moving forward, our management team, including myself, will remain dedicated to ArisGlobal full-time and will continue to manage the company as a standalone entity for the years ahead. Our goal is to continue our strong growth through product innovation, customer satisfaction and industry thought leadership. We are confident that the resources and expertise provided by Nordic Capital will help us achieve this. We feel that you, as our valued customer, will benefit from this partnership as well.

Our unwavering focus on your needs will continue to be the core of who we are as a company. It drives the development of our LifeSphere platform and it fuels our passion for becoming the premier innovative technology company in the world.

I am more excited than ever about the future for the ArisGlobal team and our customers.

Sincerely,

Sankesh Abbhi
President and CEO
ArisGlobal, LLC

On June 5th, 2019, ArisGlobal held a webinar focused on the “Key Use Cases of Automation in Pharmacovigilance.” During that event, 84% of attendees indicated a significant increase in their case volumes over the last five years. Only 15% considered their case volume increases to be ‘slight.’

The data point above reminds us that increasing ICSR case volumes remain a major challenge within the life sciences industry. A challenge, in fact, that we’ve been working closely with top life sciences customers like the FDA and Johnson & Johnson to solve. Nearly a year-and-a-half ago, we wrote a blog offering advice as to how to address this challenge: “The Push-Pull of Artificial Intelligence in Pharmacovigilance.”

How have your case volumes changed over the period of last 5 years?

Fast forward to today, and it’s clear from the results of the webinar polling question that this issue is more prevalent than ever. Increasingly stringent regulatory requirements only add to the complexity of the challenge. As volumes grow, budgets for safety case processing are generally not trending upwards at the same pace. Many PV budgets are flat or drug safety teams are being asked to do more with less. The mandate from executive management is clear: find ways to improve productivity.

Given this reality, a PV department’s reasonable action plan can’t be to repeat the same processes and use the same tools but hope for better productivity and quality. Advanced next-gen technologies – cognitive automation that utilizes artificial intelligence (AI) and machine learning (ML) and cloud computing that helps to drive down costs and improve scalability – are proving key to increasing throughput and preparing for the future.

In our next blog, to be published next week, we will discuss the status of strategic planning around automation that’s underway within life sciences organizations. We will also introduce use cases for automation in PV. If you can’t wait until then, view the on-demand webinar and download our white paper “Cognitive Computing in Pharmacovigilance: Revamping Drug Safety Using an Advanced Computing System.”

(This is Blog One in a Series of Three Blogs from the Key Use Cases of Automation in Pharmacovigilance Webinar.)

Editor’s Note: ArisGlobal would like to invite you to register to attend a complimentary lunch-and-learn workshop on July 18^th in Cambridge, MA. “Building an Automation-Centric Approach to Drug Safety.” During the two-hour workshop, Edwin Raj, Senior Director and Head of Safety Operations, AMAG Pharmaceuticals will share how they have replaced their legacy Argus system and are moving away from repetitive manual tasks by automating patient data collection from any source, which reduces errors and increases cost savings. Space is limited, so register soon if you are available to attend.

On June 5th, 2019, ArisGlobal held a webinar focused on the “Key Use Cases of Automation in Pharmacovigilance.” During that event, 84% of attendees indicated a significant increase in their case volumes over the last five years. However, only 64% have a plan in place to solve this challenge using automation, and 27% reported that they don’t know enough about automation to embrace it.

As covered in our first blog in this series, an ongoing and significant increase in ICSR case volumes is challenging today’s pharmacovigilance (PV) department. This was confirmed by 84% of our webinar attendees who, when asked “How have your cases volumes change over the last 5 years?” responded that their organization’s volume increase was significant. This rise in reported adverse events (AEs) impacts organizations from a cost, resource and compliance perspective.

Recent advancements in technology are enabling automation to help address the growing PV challenges organizations face. Cognitive computing, which utilizes artificial intelligence, machine learning and natural language processing, and robotic process automation (RPA), are driving better productivity and case quality. In fact, ArisGlobal has spent the last few years developing this technology around real-world use cases in close partnership with clients like the FDA, Boehringer Ingelheim, Biogen and AbbVie, among others.

Yet, when our webinar attendees were asked “Does your company have a strategic plan for PV Automation? ” responses were a mixed bag. One-third of attendees indicated their company had an automation plan and that it was one of their highest PV priorities. Another 30% shared that they had a plan, but that it wasn’t seen as a current priority. The remaining respondents didn’t have any strategic automation plan either because they didn’t know much about automation (27%) or because it wasn’t viewed as a current priority (9%). With this smaller group, one might surmise that their company’s case volume activity didn’t warrant improved productivity.

Does your company have a strategic plan for PV Automation?

For those where resources are constrained and improved efficiency is desired, moving forward with creating and implementing a PV automation strategy first begins with understanding the inherent value that cognitive computing can enable across core PV processes — duplicate check, case intake, narrative generation, quality check, follow-up processing, and more – for automating manual and repetitive tasks, reducing error, and reducing cost.

ArisGlobal’s real world experience is showing that automation can drive significant productivity gains. For example, the intelligent optical character recognition used by our LifeSphere MultiVigilance solution can significantly reduce data entry effort for structured data, such as Serious Adverse Event (SAE) forms, by as much as 50%. To gain a better understanding of the automation use cases we’ve focused on, ArisGlobal offers a variety of resources to read, view or attend:

• View the on-demand webinar Key Use Cases of Automation in Pharmacovigilance to learn more about specific ways automation can be applied for streamlined case management.
• Read our white paper “Cognitive Computing in Pharmacovigilance: Revamping Drug Safety Using an Advanced Computing System” and peer-reviewed article, “Cognitive Pharmacovigilance: Business Perspective.”
• Attend a complimentary lunch-and-learn workshop on July 18^th in Cambridge, MA. “Building an Automation-Centric Approach to Drug Safety.” During the two-hour workshop, Edwin Raj, Senior Director and Head of Safety Operations, AMAG Pharmaceuticals will share how they have replaced their legacy Argus system and are moving away from repetitive manual tasks by automating patient data collection from any source, which reduces errors and increases cost savings. Space is limited, so register soon if you are available to attend.

(This is Blog Two in a Series of Three Blogs from the Key Use Cases of Automation in Pharmacovigilance Webinar.)

Stay tuned. In part 3 of this 3-part blog series, to be published next week, we will explore and share more specifics on the various use cases discussed in the June 5 webinar.

On June 5th, 2019, ArisGlobal held a webinar focused on the “Key Use Cases of Automation in Pharmacovigilance.” During that event, 84% of attendees indicated a significant increase in their case volumes over the last five years. Although the stage of planned or currently adopted levels of automation varied, attendees had some thoughts to share about where automation should be prioritized once adopted.

In our June 2019 webinar “Key Use Cases of Automation in Pharmacovigilance”, Dr. Tims Thimmanna and Dr. Swati Nayak presented how automation addresses specific areas of PV-related changes – case intake, data entry, dictionary coding, duplicate check, follow up, narrative generation, causality assessment and submission. During the webinar, we asked respondents where their automation priorities were across the case processing workflow. The results were highly distributed, which reaffirmed our belief that automation can have a positive effect in many different places, as we’ve seen from working on automation use cases directly with some of the industry’s largest organizations.

Indeed, robotic process automation (RPA) can be leveraged to automate manual, repetitive steps and is best used in cases where human intervention and decision-making is not typically required, whereas artificial Intelligence (AI) and its sub-categories can mimic human decision-making to read, interpret, and analyze source documents and determine the appropriate actions required. For example, natural language processing systems can be used in literature surveillance and review of medical literature. Image recognition systems can be useful in medical review and assessment of laboratory reports. Machine learning can be used in performing logical steps of case processing.

Overall, these cognitive computing tools can augment the performance of a company’s pharmacovigilance staff, reduce the volume of manual and repetitive tasks and allow a PV team to focus on more value-add activities.

Which areas of PV are you most likely to automate?

(This is Blog Three in a Series of Three Blogs from the Key Use Cases of Automation in Pharmacovigilance Webinar.)

We also invite you to register to attend a complimentary lunch-and-learn workshop on July 18^th in Cambridge, MA. “Building an Automation-Centric Approach to Drug Safety.” During the two-hour workshop, Edwin Raj, Senior Director and Head of Safety Operations, AMAG Pharmaceuticals will share how they have replaced their legacy Argus system and are moving away from repetitive manual tasks by automating patient data collection from any source, which reduces errors and increases cost savings. Space is limited, so register soon if you are available to attend.