PharmaVOICE: Clinical Leader of Cognizant’s Life Sciences R&D Practice Makes Case for Transforming Clinical Trials Through Proactive Performance Management

“Today, global biopharma and medical device companies lament their inability to effectively harness the wealth of data they generate to help guide their thinking and inform decisions. The result is that organizations require valuable resources to spend enormous amounts of time preparing reports that often contain outdated and incomplete data across global geographies,” writes Larry Florin. Excerpts:

“Global trial oversight is daunting and challenging. Data updates that reflect the “here and now” are vastly better than trying to make decisions based on three to five-day old information — particularly on a global basis.  Companies that suffer from this data lag may be at a competitive disadvantage to their peers that can react more agilely, the difference between being first or second or third-to-market.

Procuring technology solutions that can aggregate, organize and assure data quality, security (and privacy) to provide meaningful insights to all key stakeholders (sponsors, CROs, investigators, and patients), is critical to overcoming the challenges associated with managing increasingly complex, global development programs. But the solutions need not be complicated. Straightforward business processes and technology applications that provide configurable analytics and reporting platforms that accept near real-time data feeds can have an enormously positive impact.

One way companies can eliminate data lag is to employ proactive performance management (PPM) (including risk-based project management and monitoring) practices.

Employing a risk-based PPM model means that organizations prospectively take time to think about how to address critical risks and issues that may arise during a study. To gain visibility to these emerging problems, analytics and reporting platforms should be designed to help the clinical trialist ‘zero in’ on what is important by signaling those items that are approaching or have exceeded predefined threshold boundaries.

The most valuable technology platform systems also possess an extra ingredient; not only can they identify risks, but they also make the information actionable by suggesting actions to be taken (or record why not taken); documenting the results of the actions; capturing their timeliness, describing who was involved and if the issue was escalated, and assuring that all of the activities are fully auditable and traceable.

All of these features help stakeholders develop a culture of continuous learning and afford organizations the knowledge to proactively apply the learnings to other studies. Moreover, traceability and auditability of the actions taken, including preventative activities, satisfies regulatory requirements that serve to prove that the sponsor and CRO implemented “procedures necessary to secure the quality of every aspect of the trial.”

Successful companies will exploit PPM to avoid, adjust to, mitigate, and remediate problems. Embracing quality-by-design (QbD) methodology coupled with a risk-based project management and monitoring approach that harnesses data to provide clear visibility of all facets of a program will permit organizations to learn and adapt more rapidly, providing — (even temporary) — strategic advantages. These capabilities fundamentally change a company’s way of working and permit individuals, by prospectively defining key risks, to focus on issues that matter. Ideally these new business practices will translate into shorter cycle times, improved data quality and enhanced patient outcomes.”

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