Life Sciences: TMF Initiative

XL-Lead Consulting recently worked with a Global Pharmaceutical Company to standardize a global process for developing a Target Master File (TMF).  XL-Lead’s staff in Beijing in addition to its Irvine employees helped make that vision a reality.

“The most challenging part was working with the Regional Sites and discovering that each country had their own way of tracking and archiving their TMF,” says Consultant Nadu Patel. “What’s more is that they each had their own definition of what goes into a TMF.” The complexity really comes from the fact that each regulatory agency around the world is looking for different things. How do you develop one process with so much diversity?

“You really have to focus on the common objectives,” answers Patel. “You build an overarching solution with enough flexibility that each country can still fit into it.”  Not easy by any means! It took XL-Lead Consultants 8 months to develop the overarching process, train the regional sites, and to implement a single global solution to store the TMF.

“We aren’t done by any means,” continues Patel. The landscape around the TMF seems to changing rapidly with many new technology vendors entering into the space. “We’re keeping an eye on what’s developing so that we can make the most informed recommendations for our clients.”