As stressed in the first part of this series, implementing a well thought out lessons learned process will enable teams to honestly assess performance and identify areas for performance improvement while avoiding repeat mistakes that can lead to increased cycle times. A successful lessons learned process could provide a company with a competitive advantage by having high performing teams in their organization that get to decisions more efficiently. The process will enable teams to:
Share innovative ideas and experiences
Identify mistakes to avoid going forward or on future projects
Collecting the knowledge: The timing of when to perform a lessons learned assessment can be determined 1) by the project team at project inception, 2) by company policy at specific times during a project, or 3) after a major project milestone has been achieved, e.g., completion of project start-up, patient enrollment completed, data base lock, etc.
Capturing the knowledge: The successful implementation of a lessons learned process requires the use of tools that enable easy data collection and review.
Sharing the knowledge: Establish a clearly defined meeting structure that enables open discussion by team members of the information collected and summarized with the goal of reaching a consensus on the lessons learned from the collected data and agreeing on an implementation plan.
Storing the knowledge: Having easy access to historical lessons learned data is essential. Consideration should be given to the use of key words, drug category, etc., so the information can be easily retrieved for future reference.
In the September issue: Implementing the lessons learned process
Written by Guest Writer Larry A. Blankstein, Ph.D. Blankstein is a clinical research scientist with more than 20 years in pharmaceutical and biotechnology drug development and operational execution. He has worked for both CROs and sponsors, enabling him to bring a collaborative approach to partnerships. His experience includes phase I-III studies; project, study budget and CRO management; clinical operations; and CRO selection. He is leading CenterWatch’s newest service, Team Performance Optimization Process (T-POP), offering insights into clinical project teams’ performance with a lessons learned evaluation to develop an action plan for excellence.
This article was reprinted from Volume 22, Issue 07, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact editorial@centerwatch.com. Subscribe >>
