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Mounia Lahjou, Project Direct at Innovaderm has more than 17 years of experience in the industry. With her extensive skills and experience in the pharmaceutical industry, Mounia has made significant strides in the field. She is a disciplined professional with meticulous attention to detail, demonstrating proficiency in her work. Her deep understanding of drug development processes further enhances her comprehensive skill set.
In this episode, we will be exploring some lessons learned in phase 3 from a project manager standpoint, focusing the following lessons:
- The Power of Documentation
- Adherence to Process Compliance
- The Pursuit of Process Improvement
The Power of Documentation
In clinical research, a common saying resonates, “If it is not written, it did not happen.” This phrase rings particularly true when managing long-term studies involving numerous sites and a large team. The importance of documentation becomes evident in such scenarios, where decisions, events, and action items need to be recorded meticulously.
Understanding who made a decision, when it was made, and the rationale behind it is crucial for traceability. Storyboarding while the information is fresh in mind is recommended, as details of even the most significant situations can fade over time. In 6 months or a year, memories might fail, team members might change or leave, and if there is turnover, it becomes a reality.
Should the need arise to retrieve this information in the future for an inspection or any other purpose, without proper documentation, one might find themselves sifting through multiple communications to find what they are looking for.
Therefore, discipline in documenting information in a centralized log is encouraged. Despite the challenges of being deeply involved in the action, multitasking, and having so much to do, it is important to pause, reflect, and write things down.
Adherence to Process Compliance
In this context, the establishment of numerous processes and SOPs is crucial. The industry is highly regulated, with clear delineation of roles and responsibilities.
Effectiveness checks are necessary to ensure adherence to processes. Vigilance for gaps is required. To illustrate, consider the task of verifying debarment checks. A process is in place, which is excellent.
However, given the lengthy duration of studies, team members may transition or forget, leading to tasks being overlooked or incorrectly executed. This issue often surfaces too late, at the end of the study.
Therefore, the implementation of a verification process and ongoing effectiveness checks is essential to prevent gaps and reinforce team behavior. While it may seem straightforward, it requires discipline.
The Pursuit of Process Improvement
Mistakes are a part of the clinical research experience, there is no way around it. Once these errors are identified and documented, understanding their root cause becomes crucial. Learning from these mistakes helps prevent their recurrence in the future. A pause to assess the situation, followed by the implementation of corrective measures and process improvements, ensures that the same errors do not happen again.
Sharing this information is vital to ensure awareness and avoid repetition of the same mistakes. While it is beneficial for the team to be informed, it is equally important for others to be aware as well. Ensuring that all studies are conducted as they should be, and implementing a verification process, helps confirm that updates are understood, and improvements are being made.
As studies become increasingly complex and global, adapting processes to align with this new reality becomes necessary. Working together to implement everything learned is the key to improvement and progress, both as a team and as a company.
As we conclude another illuminating episode of Phase Forward, we find ourselves at the crossroads of science and progress. Remember that behind the jargon and statistics, lies stories of unwavering commitment, meticulous observation, and the pursuit of evidence that shapes our understanding of health and disease. Stay at the forefront of knowledge and innovation and follow Phase Forward on your preferred platform. My name is Valerie Coveney. Thank you for joining us. Until next time.
Let’s shape the future of research and make a difference in the industry, gain Innovaderm’s support in your upcoming trial and propel your study to new heights
