Electronic trial master file (eTMF) is a content management system that is specially designed to maintain clinical trial data in the life science organizations. One of the crucial parameter related to such kind of data is that it should comply with government rules and regulation of a particular country. These eTMF solution are above the traditional folders and includes entire content lifecycle. The most common features of eTMF software are content integration, control, storage, and interpretation of data related to clinical trials.
Electronic Trial Master File (eTMF) Market: Drivers and Challenges
Life sciences companies that engage in clinical trials are required to document the important issues of the trials. The trial documents facilitates the conduct of clinical trials, and prove the quality data produced. The various governments across the world requires that trial documents filed and maintained in both the trial sponsor and the tester file. Now-a-days, according to various government’s requirements, the final close-out of a trial can only be accomplished when the medical site monitor has reviewed and confirmed that all necessary documents are in the suitable folder.
Due to these strong reporting requirements, sponsors are often tangled in internal and regulatory audits for discrepancies in the trial master file. On numerous occasion, required documents are missing at either the sponsor or trial site. Because of these complexity involved in manual documentation, there is a requirement of electronics trial master file (eTMF) processes.
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Electronic Trial Master File (eTMF) Market: Segmentation
Segmentation on the basis of component:
Segmentation on the basis of deployment:
Segmentation on the basis of end-user:
- Pharmaceutical Companies
- Contract Research Organization
- Life Science Organization
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Electronic Trial Master File (eTMF) Market: Competition Landscape
Few of the companies in eTMF market are: SureClinical Inc., Montrium Inc., TransPerfect Trial Interactive, Veeva Systems, Phlexglobal Ltd, Paragon Solutions, Mastercontrol, Inc., Wingspan Technology, Inc., Arivis AG, Biovia (QUMAS), Ennov, Database Integrations, and PharmaVigilant I-Vault.