Trial Master File (TMF) Operations

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Providing Specialist, Technology-Enabled TMF Solutions and Support

Clinical trials can be large and complex, involving many departments and partners. As a result, Trial Master File (TMF) management can become a difficult task. We are a specialist provider of technology-enabled TMF solutions and other support services for the global clinical research market.

  • 130 studies managed in Sponsor TMFs
  • 250+ experienced TMF team members globally
  • 700 active TMFs
  • 150,000 documents processed monthly

 

Our Skilled, Dedicated Team Manages the TMF Process with a Focus on Quality and Compliance

Our solid TMF infrastructure and qualified staff, with the prerequisite experience and proficiency in TMF processing, are here to help ensure success for your trial. Timely, thorough and accurate processing of TMF documents is among the most important services we provide.

Each member of our TMF processing team goes through extensive document recognition training and quality assessment and has very specific TMF industry experience.

 

Delivering Quality through Proven Process and Technology Solutions to Meet Your TMF Needs

We have spent more than a decade developing processes and technology solutions to ensure timely, thorough and accurate processing of TMFs, and we have managed the industry transition from primarily paper management to a combination of paper and electronic to entirely electronic TMF management.

As a result, we craft our services based on whether our customers require paper-only, paper and electronic, or electronic-only TMF management. We also have experience in more than six main eTMF technologies, such as Veeva, Wingspan™, Trial Interactive, PhlexEview, FirstDoc and Documentum®, as well as seven customized versions of these core eTMF technologies.

We have received numerous awards from highly acclaimed industry organizations, including Scrip and CenterWatch, for our relationships, quality, processes and performance. Our Trusted Process® methodology has proven to be an essential ingredient for delivering high quality, predictable and reliable results, and we have the metrics to prove it.

Our TMF team will ensure we provide the best-trained teams and highest quality data-driven metrics/results and reports to meet the rigor of your QC and reporting standards.

 

FSP Model

We offer our TMF services in both a full service and FSP model. All employees that work in this area are active in the TMF Drug Information Association (DIA) community and speakers at various industry TMF conferences. They use their previous expertise and knowledge in the planning, design and implementation of numerous TMF service engagements.

As a result, we are able to provide a tailored service offering to ensuringe we build a team of highly skilled, dedicated resources necessary to manage the TMF processing and reporting volume with a focus on quality and compliance.