Second of three parts

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:

1. Share innovative ideas and experiences
2. Identify mistakes to avoid going forward or on future projects
3. Identify training needs
4. Document/share knowledge (technical, project-related, management)
5. Identify areas for quality improvement
6. Provide project history.

Key components

• 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 >>