Electronic Trial Master File (eTMF) is a content management system for the Bio-Pharma industry which includes protocols, strategies, and tools used throughout the lifecycle of the clinical trial. An eTMF digitally captures, shares, and stores the essential documents and content generated in a clinical trial.

Increasing Adoption due to benefits Offered by eTMF Systems drive the Electronic Trial Master File (eTMF) Systems
Post Covid-19 pandemic, the volume of clinical trials and volume of data generated increased exponentially, which in turn has fueled the adoption of eTMF systems by Bio-Pharma companies. The eTMF systems give real-time visibility of the clinical trial data and activities conducted at scattered sites across the globe.Utilizing eTMF yields advantages such as improved operational efficiency, expedited timelines, cost reduction, and risk mitigation.

For instance,

§ In June 2022, Anju Software Inc., announced the introduction of its new cloud-based eTMF product. The product will expedite the collaboration between CRO’s, sponsor and sites to manage the clinical data efficiently in a regulatory-compliant environment

Renewed surge of Electronic Trial Master File (eTMF) Systems following the Pandemic Drives the Electronic Trial Master File (eTMF) Systems Market
The Covid-19 Pandemic has caused a change in execution of the clinical trials. Bio-Pharma companies responded to travel bans and lockdowns by implementing virtual clinical trials, which involved the utilization of remote patient monitoring, telehealth services, wearable devices, and applications. These measures were implemented to prioritize the safety of patients. The vast number of clinical trials conducted for rapid development of vaccines during the pandemic had also burdened the healthcare sector. With rise in the number of trials and its data, there was a shift from manual TMF systems to eTMF systems, for seamless management of data in decentralized clinical trials. The other factor which had set in motion this shift was the clinical data retention regulation policy to maintain the data for 25 years by the Sponsors/CRO’s.

North America Expected to Hold a Major Share in the Electronic Trial Master File (eTMF) Systems Market in coming years
From a geographical perspective, North America holds a major market share of the Electronic Trial Master File (eTMF) Systems market. This can be Primarily attributed to the growing number of clinical trials & volume of data generated, favorable funding environment to support clinical trials, well-developed healthcare IT infrastructure, and presence of several key players in the region However, the Asia-Pacific region is expected to witness strong growth in the coming years due to flourishing Biopharma industry, growing outsourcing of clinical trials in the region, and rapid development of vaccines by Biopharma industry due to Covid-19 Pandemic.

Competitive Landscape : Electronic Trial Master File (eTMF) Systems Market
Some of the key players operating in the market include Veeva Systems, Aris Global LLC, Master Control, Inc., Montrium, Clinevo Technology, Oracle Corporation, Phlexglobal, Transperfect, Aurea Software, Labcorp (Covance, Inc.) and Sureclinical, among others.

Organic and Inorganic Growth Strategies Adopted by Players to Establish Their Foothold in the Electronic Trial Master File (eTMF) Systems Market
The players operating in this market are adopting organic and inorganic growth strategies such as launching new products/technologies, collaborations, and acquisitions to garner higher market share. For instance,

§ In February 2023, TransPerfect Life Sciences announced that Surrozen has selected its Trial Interactive eClinical platform, including electronic Trial Master File (eTMF) and TMF solutions to create a centralized, quality-focused approach to TMF management

Electronic Trial Master File (eTMF) Systems is a growing market that is expected to gain traction in the coming years due to increasing eTMF system adoption, rising R&D investments by pharma-biotech companies, favorable government funding & grants to support clinical trials, and aggressive organic and inorganic growth strategies employed by the players.

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