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TMF Expert Insights
Friday, June 16, 2023 | 12:03 PM
The life sciences industry faces a serious problem—a widespread Trial Master File (TMF) skills gap. There are simply not enough skilled TMF professionals to support clinical research's explosive growth and complexity. The consequences of this skills gap are far-reaching, with the rising occurrence of TMF-related inspection findings posing a significant threat to patient access to life-saving treatments. Clinical trial leaders are confronted with the clear-cut reality of potential inspection findings and the subsequent delays that can occur, hindering the timely delivery of vital therapies.
Recognizing the importance of addressing this issue proactively, organizations must take a particular approach to managing their risk profile. One crucial aspect of reducing findings in future regulatory inspections lies in establishing and nurturing a set of essential skills within the 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, consisting of seasoned industry experts, offers invaluable assistance in incorporating key skills into the day-to-day operations of TMF teams.
In our ongoing blog series focusing on TMF skills, we interviewed Laurel-Ann Schrader, Trial Interactive’s Director of Client Solutions and a recognized industry expert. Laurel identified the top five skills that TMF team members should prioritize for their professional development. These skills serve as pillars for building a competent and resilient TMF team. Let's delve deeper into these skills:
To set TMF teams up for success, it is imperative to stay up-to-date with the latest regulatory updates and industry best practices. In today's rapidly evolving business landscape, where regulatory frameworks can undergo frequent changes, maintaining a proactive approach to monitoring and understanding these updates is crucial. Laurel emphasizes the importance of actively engaging with online forums, attending conferences, and leveraging social media platforms as invaluable sources of information. These platforms provide a vibrant space for professionals to exchange knowledge, share experiences, and participate in discussions centered around emerging regulations, industry standards, and best practices.
Furthermore, the Client Solutions team engages in internal discussions to identify key regulations that are applicable to their business. This collaborative approach ensures that all team members are aware of the regulations that may impact their operations. By discussing these regulations, the team can collectively assess the potential impact and strategize the necessary actions to remain compliant.
Adopting this comprehensive approach, which encompasses attention to detail, organizational skills, knowledge of regulatory requirements, communication skills, and time management, underscores the dedication of Laurel's team to upholding a compliant and forward-thinking organization. It empowers them to adapt swiftly to regulatory changes, mitigate legal risks, and retain a competitive edge within the industry.
As our blog series continues, we will delve deeper into additional skills and insights provided by industry experts from LMK. These insights will shed further light on the complex nature of TMF teams and the critical competencies required to excel in this ever-evolving field. Stay tuned for our next segment in the series, where we will explore more aspects of TMF team skills and development.
A Step in the Right Direction for Clinical Trial Management: Improvements on the GCP E6(R3) ICH Harmonized Guidelines