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.
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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.
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
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.
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Market: Regional Overview
In the North America region, eTMF is the top priority for the life science institutions to stay ahead in the competitive business environment, hence, life science industry is rapidly witnessing the growth of eTMF solutions.
In Asia-Pacific region, pharmaceutical and life science organizations are adopting eTMF software slowly and gradually. In China, eTMF is becoming one of the top technology issues for the life science organizations, while in India, most of the life science organizations are still reluctant to deploy eTMF solution.
In Europe region, huge spending by clinical trial research organizations in eTMF software is driving the growth of the market. Europe has many economical sound economies such U.K. and Germany and enterprises operating in this region invested significantly in the eTMF software market.
In Latin America and Middle East Africa regions the growth of eTMF software market is still low because enterprise across these regions don’t want to increase their capital expenditure by spending money on eTMF solutions.