By Laurel-Ann Schrader, Director of Client Solutions
As a result of the explosive growth and complexity in clinical research, the life sciences industry is now facing a widespread Trial Master File (TMF) skills gap and a shortage of TMF professionals. This issue, paired with an increasing number of TMF-related inspection findings poses a significant threat to patient access to life-saving treatments. Clinical trial leaders are acutely aware of the potential inspection findings and subsequent delays, hindering the timely delivery of vital therapies.
To proactively tackle this issue, organizations must manage their risk profile effectively. A crucial aspect of reducing findings in future regulatory inspections lies in nurturing essential skills within TMF teams. This is where the expertise and support of TransPerfect Trial Interactive and the LMK Clinical Research Consulting teams come into play. The Trial Interactive team, comprising seasoned industry experts, provides invaluable assistance in incorporating critical skills into the day-to-day operations of TMF teams.
In an ongoing blog series focusing on TMF skills, authors interviewed Laurel-Ann Schrader, Trial Interactive’s Director of Client Solutions, who identified the top five skills that TMF team members should prioritize for their professional development. Delve into these skills by accessing the full article below.