Message To ClinOps Leaders: The Organizational Planning Textbook Wasn't Written For This!

By Eli Lipsky, Associate Director of Technical Operations, Trial Interactive

Business technology, in any industry, is only as good as the people, planning, and processes around it. After ten years of e-clinical implementations, we can say from experience that operational planning requires a very industry-specific lens.

The heavily regulated nature of the clinical research industry presents an opportunity for operational leaders: adapting the organizational planning playbook. In other industries, increased oversight is generally received as a threat to operations remaining nimble and responsive. In Life Sciences industries, where safety of patients in need of new medicines should be the top priority, we recognize that innovation necessitates heightened accountability and the highest expectations for standards and quality. As an industry, we adapt to this in an interesting way. Organization leaders respond to the expedience and efficiency challenges of regulations by re-examining and rewriting best practices that benefit the industry as a whole.

Traditional leadership instincts and planning methodologies designed for less regulated industries can fail or fall extremely short in the execution of clinical research, particularly as it applies to things like eTMF management. As a result, it is important to establish some broad guidelines to serve as a compass for planning and forecasting in an environment with such strict parameters. The following five considerations can help organizations make better decisions.