Aligning Clinical And Regulatory Functions - Part 2

April 11, 2018 James Linnington

A Unified Approach to Aligning Clinical and Regulatory – Part 2


In my last blog post I discussed that despite the strides most life science companies have made to automate and eliminate paper-based processes, they still face a major obstacle in the inefficiencies existing across different processes; below I will discuss how to set out the strategy in an aligned and unified approach.

A Common Document Foundation

The first step in the process is to embrace the concept of a common document strategy, and the first principle is convergence of data: the linking of documents from one domain to the other. Instead of existing in silos, documents can be managed in a single repository; for example, the approved version in the regulatory system can be linked directly from the clinical R&D system. Essentially, content associated with the asset, starting at discovery, stays with it throughout its lifecycle. Stakeholders can enter data from the source once and as close to the source as possible, ensuring that the data continues be linked to those documents. Now, you have a single authoritative record of truth.

With a document management foundation that spans all phases of development – one place to store clinical and regulatory documents – you can eliminate duplication and re-entry of data, reducing cycle times and removing bottlenecks. Assembly of clinical study report (CSR) and electronic common technical document (eCTD) can take place on an ongoing basis. The time from last study completion to submission is minimized dramatically, and the entire process of transferring and QC of documents disappears. The eCTD and electronic trial master file (eTMF) are automatically synchronized to prepare for easy inspections.

A Full Lifecycle View with What-If Analytics

With a single solution for study startup, study execution and regulatory lifecycle management, your team can quickly locate, verify and maximize the right information at the right time. Guided workflows and real-time alerts can expedite reporting of amendments and supplemental changes to regulatory authorities. Post-approval, you can respond faster to product changes, compliance concerns or health authority requests.

This unified approach enables you to streamline your electronic document distribution and storage, while allowing rapid access for reviewers and internal stakeholders alike. Executives gain a view of the full lifecycle of a product, such as study milestone performance and cycle time, site and subject enrollment planning, site progress, subject recruitment progress, registrations, submissions and drug safety activities. They can use analytics to determine how a potential labeling or product change will affect a registration, as well as the impacts on study conduct.

A Collaborative Process Across Domains

While the sharing of workflows across your organization might require some cultural rethinking, the fact is that excellent coordination between study startup groups and regulatory can dramatically improve operational efficiency, productivity, accuracy and compliance downstream. And with innovations from PAREXEL, implementing a common document and data management foundation is becoming a reality. This approach is at the heart of PAREXEL’s Perceptive Cloud – bringing together study startup and execution, data management and monitoring, regulatory information management (RIM) and document management.

Perceptive Cloud for Cost-Effective Innovation

Once you have embraced the concept of document sharing throughout your organization, the next clear strategy is to move it to the cloud. A cloud strategy makes it much easier to begin the digital transformation journey – giving you a clear starting point, and removing concerns about your long- and short-term investment thanks to the predictable cost.

Today, even the more traditional and conservative companies are investing aggressively to move applications and analytics to the cloud. They are taking advantage of opportunities to implement various forms of master data management with a focus on data quality and harmonization, with greater analytics capabilities in place.

The Perceptive Cloud represents the technology alliance between PAREXEL and Microsoft. Perceptive Cloud, built on Microsoft Azure, combines the power and intelligent capabilities of cloud computing, global regulatory compliance and best-in-class security with PAREXEL’s industry expertise and technology solutions.

This truly breakthrough convergent platform streamlines workflows for a seamless user experience with persona-based access, while improving transparency and enabling advanced insights to drive better decisions, faster.

With Perceptive Cloud, you can leave behind the rigidity of hardware, third-party software and complex data infrastructure, as well as the unpredictable costs. The subscription-based solution provides privacy, security and access control with transparent pricing and no surprises. You can be confident that PAREXEL will address data integrity and security throughout migration from legacy systems. The flexible, open, scalable architecture simplifies data integration and transfer, and enables faster response to changing market demands.

Doug Burgener

Regulatory & Clinical Solutions

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