Blog: Creating a Unified Clinical and Regulatory Data Management Strategy

“In the increasingly complex environments of product development lifecycles, industry leaders are looking to streamline and transform their cross-functional business processes and strengthen their governance by creating common, strategic capabilities. Having these key unified capabilities between Clinical and Regulatory departments is key to exchanging critical information. That’s what this webinar will explore in more detail.”ArisGlobal held a mid-January webcast “From Good to Great: The Benefits of Unified Clinical and Regulatory Data Management Strategy” with the goal of examining the challenges involved, benefits to be gained, requirements of unified regulatory and clinical business processes, and recommendations for taking the next steps forward. ArisGlobal presenters, Vitthal Gouri, Associate VP, Clinical Solutions, and Pratyusha Pallavi, Associate Director, Regulatory Product Management, shared their respective expertise to advance the viewpoint that it’s time to explore the significant gains to be achieved from this unification with the right approach, advanced platform, cross-department participation and commitment across clinical, regulatory and IT departments. The webcast audience, comprising of strong representation across clinical, regulatory and IT, responded to polling questions that helped throw light on the current reality facing companies seeking to undertake the mammoth task of cross departmental unification. Beginning with the polling question on “What has been your biggest challenge in relation to Clinical and Regulatory technologies?”, the attendee polling results across the five possible responses clearly showed that the regulatory and clinical departments are grappling with a multi-faceted challenge. The results showed nearly equal strength except for one. Laborious Upgrades and Validation Cycles ranked highest with 25%, but the lack of a Single Source of Truth, Complexity of Desired Process Automation, and Data Quality Not Available in Real-Time all tied at 21%. Trailing last at 13% was Lack of Common Terminology.

Integration Is Not the Same as Unification

After discussing the challenges, Vitthal delved into how today’s current architecture that is Web-based and involving loosely coupled integrations continues to present costly and complex issues that, at the end of the day, doesn’t represent what an effective drug development environment requires. Presenting a clear end-to-end development process diagram and discussing the interwoven business processes of clinical and regulatory, Vitthal and Pratyusha shared how there is clearly a lot of back-and-forth between the two departments in terms of processes, data and documents, all of which requires a unified database. The need for a cognitive computing platform, a defined and shared library, repositories, inter-connected business processes and stakeholders is where unification can begin. But where do most companies stand now in achieving a unified clinical and regulatory data management strategy?  The webcast’s final polling question showed some interesting findings: More than half fall in the exploration-to-education stage, and yet only 13% have business leadership fully engaged in achieving a unified approach. Finally, not a single company has IT fully engaged, with implementation underway. Pratyusha explained that this is not a surprise given that Life Sciences is still at the start of the of digital maturity curve, unlike other industries. While Life Sciences has started to invest in exploring the use cases of unification between Clinical and Regulatory, project funding to initiate full scale implementation is much slower currently. Intriguing questions from attendees on aspects like cross-department unification examples, disadvantages of unification, common data model responsibility, and recommended first steps were covered. We are confident that the information shared will likely lead to ongoing discussions within attending organizations. We encourage you to view the on-demand webcast for more details on what was shared. Have any questions? Send an email to [email protected].

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