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Welcome to Keefer Consulting!

My goal for this website is to present content that will help biopharmaceutical companies discover strategies for improving R&D productivity and compliance.

Watch for an upcoming whitepaper about reducing the time and cost of transferring electronic trial master file records among sponsors, CROs and other collaborators in your trial management process.

Please feel free to contact me to discuss any questions or ideas you discover.

Ken Keefer
215-462-1601
KKeefer@KeeferConsulting.com
Schedule a 15-minute call

Keefer Consulting helps biopharmaceutical companies:

  • Improve collaboration and bring better ideas to market quickly.
  • Accelerate drug development and reduce time-to-approval.
  • Minimize time-to-launch and maximize profits before patents expire.
  • Reduce non-compliance risks across the drug development lifecycle.
  • Improve data quality and communicate better with regulators.
  • Respond more rapidly to regulatory and market changes.
  • Maximize their return on investment in new compounds.

Has your company started planning for eTMF-EMS?

The electronic Trial Master File Exchange Mechanism Standard (eTMF-EMS) promises to reduce preparation time and costs for inspections and submissions.

Sponsors, CROs, and eTMF vendors employ different metadata conventions to describe TMF documents. They reconcile differences for each exchange by mapping the metadata of the sending party to that of the receiving party. They may enter metadata manually in creating records that correspond to the ones they receive, or they may pay for custom programming to automate this process. Many companies avoid possible delays by transferring all content at end-of-study. Problems in quality, timeliness, or completeness may emerge as inspection or submission dates loom.

The TMF Reference Model defines metadata and a taxonomy for TMF content, but it is not an enforceable standard. Companies may choose whether to adopt the model and how to use it. It does not provide standards for metadata, audit trails, or electronic signatures. It does not specify how to exchange electronic TMF content.

eTMF-EMS offers a metadata standard that eliminates the need for custom mapping. Instead, each software vendor maps its metadata once to a common eTMF-EMS protocol. Sponsors and CROs can exchange their metadata in either direction with any compliant system. Future versions of eTMF-EMS could facilitate multiple transfers over the course of a study. Keeping TMF content current could reduce preparation times and costs for inspections and submissions. This could free managers to focus on quality, timeliness, and completeness.