The last 12 months have been challenging for many in the biopharmaceutical space. Consider that industry layoffs increased 57% in 2023 compared to 2022. It’s amazing how quickly things change. During the COVID-19 pandemic, many of the same companies currently shedding employees were flush with cash and hiring like gangbusters.
Sadly, experts predict things will get worse before they get better. Many biopharmas and biotechs are in “cash preservation mode” and doing everything they can to navigate the current economic climate. In some cases, this means refinancing debt or resorting to reverse mergers. Other businesses are electing to eliminate staff and restructure their research departments.
Sometimes difficult financial decisions are necessary, but if you aren’t careful, essential activities can fall by the wayside and lead to headaches down the road. Case in point: Trial Master File (TMF) Management. You might be short-staffed, but the FDA and other regulatory authorities expect you to be inspection-ready at all times.
Here, we provide a blueprint for optimizing TMF management after layoffs and/or staff turnover. Following these 6 tips can provide peace of mind and help your team better manage their workloads.
1) Meet with Your Remaining TMF Team and Ask Them for Feedback
After layoffs occur, you need to assess their effect on TMF management. Gather your remaining TMF department employees and make time for one-on-one interviews. Ask each person how the recent staff changes could affect their workflow and document oversight. Your team’s responses can help you identify potential weaknesses and ensure TMF management stays at top of mind.
2) Prioritize Document Collection and Organization
Each clinical study that you conduct has essential documents. Gather the necessary paperwork for each one, including the study protocol, investigator brochure, informed consent forms, and regulatory submissions. Ensuring these documents are together and easy to access can take a huge weight off your shoulders.
3) Level-Up Your TMF Department with Cross-Training
The current economic climate is forcing many biopharmas to do more with less. If you’ve had to reduce staff, you probably won’t be able to hire anyone else for at least six months. Instead of waiting for conditions to improve, level up your TMF department with cross-training.
Rather than giving each TMF team member a specific responsibility, encourage them to learn multiple skills. If everyone knows the basic protocols for things like document management, TMF metrics/reporting, and corrective and preventive actions (CAPAs), mistakes are less likely to happen, even if you’re short-staffed.
4) Use Technology to Your Advantage
Modern eTMF software is capable of automating various tasks, thanks to artificial intelligence and big data. These technologies can be used to ease manual workloads and prevent human errors, but only if you’ve selected the proper settings.
Make sure you’re using your eTMF software to its fullest capacity. There’s a good chance you’ve turned certain features off in the past, so it never hurts to review the current features and update them as needed.
5) Conduct an Internal TMF Audit
Mass layoffs can significantly alter the structure of your TMF department. Because the TMF is such a crucial part of your company’s success, it’s never a bad idea to conduct an audit. Although time-consuming, an audit can help you assess the entirety of your TMF documents. This makes it easier to identify missing paperwork or lapses in documentation and can help you determine if a CAPA is needed.
6) Partner with a Functional Service Provider (FSP)
If you don’t have the internal resources to adequately manage your TMF, consider partnering with a functional service provider, like Harbor Clinical. As a full-service FSP, we have part- and full-time subject matter experts who specialize in everything from vendor oversight and quality assurance to regulatory affairs and TMF management.
We can help update and maintain your TMF or recommend an eTMF platform that aligns with your businesses’ needs. To learn more about our capabilities, call (781) 775-0342 or send an email to [email protected].
Optimizing TMF Management Amidst Staff Turnover – The Bottom Line
TMF management is crucial to your company’s success, but layoffs and staff turnover can affect its quality and accuracy. By implementing some (or all) of the strategies above, you can maintain the integrity of your documentation and be prepared in the event of an audit or inspection.
This article was inspired by Nicole M. Palmer’s recent Guest Column in Clinical Leader.