By Michael Smyth, Division President and Corporate VP, Life Sciences Solutions at TransPerfect
A well-managed eTMF saves time, money, and reduces risk. As a life sciences company, reducing clinical trial costs while accelerating processes and eliminating inspection findings is music to the ears! All of these benefits are at the fingertips of life sciences organizations, but they are elusive without the proper processes and oversight. Due to perceived operational costs, smaller companies can be hesitant to adopt an eTMF, or to surround their chosen eTMF platform with the processes and oversight necessary to truly see the full return on investment where significant “soft costs” disappear.
Part of putting the necessary eTMF processes and oversight in place and reducing the pain of inspection findings is understanding what regulators are thinking when they inspect your eTMF. The MHRA’s GCP Inspections Metrics Report for April 2016–March 2017 provides a window into companies that learned their lessons the hard way. The report covers overall findings, but in this paper we will hone in on the critical findings around the TMF and recording/keeping of essential documents.