Future-Proofing Compliance Strategy
In this confusing environment, how can companies develop a robust yet flexible approach to this compliance challenge? The
best strategy seems to combine process, people, and platform.
Process Now more than ever, companies must ensure that their standard operating processes are up-to-date, and that they can accommodate
the anticipated growth in clinical trial registries throughout the world. Acceptable process cycle and response times must
be clearly articulated, with escalation paths to manage delays. Implicit in this is a thorough examination of the cycle times
to prepare data for publication or disclosure, including time to database lock and final clinical study report.
People In response to the challenge of facilitating global compliance, many leading biopharma companies are adopting a combined centralized/decentralized
approach that maps to the realities of this business process. It will be challenging to keep pace with evolving US and global
requirements. As a result, many companies have elected to form a small internal team of "process" experts that are charged
with keeping current with emerging requirements. These process experts will work closely with globally dispersed "content"
experts who are familiar with the status of each clinical trial and the emerging data.
Platform The ever-increasing scope and complexity of this compliance process has led most companies to the realization that a manual
process—relying on e-mail and spreadsheets rather than a workflow and project management system—is simply unsustainable. Companies
looking for a platform to support a high quality trial registration process that is transparent, auditable, secure, and robust
typically require at least the following capabilities:
» A secure Web-based system to facilitate global access
» Configurable workflow capabilities that support role-based, managed-approval chains
» Integration with a range of internal systems, including clinical trial management system (CTMS) and results repositories
» Integrated reporting, both status and process metrics
» Automated e-mail notifications, driven by both workflow and escalation triggers
» A validated system to insure quality
It's evident that most companies are looking to buy—rather than build—these systems, as they consider the evolving regulations
too fluid to risk internal or custom development. If that's the case, organizations should look for a partner with internal
process expertise to ensure that requirements evolve at pace with the environment, managed hosting, and strong implementation
However you plan to respond to the ever-changing requirements for clinical trial information, it is vital that you move quickly
to formulate and implement an effective compliance strategy. After all, it's fairly certain that companies can never return
to the "Once upon a time" days when clinical trials remained a secret until the company decided it release the results. Indeed,
the rules and regs governing clinical trial mostly like will become all the more complex in the future.
Tim Bacon is president and CEO of PeerView and a founding member the International Society for Medical Publication Professionals. He
can be reached at Tim.Bacon@epeerview.com
Melanie North is vice president of compliance and program management for PeerView. She can be reached at Melanie.North@epeerview.com