Increasing Availability of eTMF and Emergence of Covid-19 to Augment Growth of Electronic Trial Master File (eTMF) Market
An
electronic trial master file (eTMF) is simply a trial master document in
electronic form. It is a content management system specifically designed for
the pharmaceutical industry, offering a formalized way of organizing, tracking,
and storing clinical trial data. Electronic trial documents are usually stored
on computers within trial execution units, or TUAs. Most documents are filed in
one of these units, with each having its own password and access code required
to open it. In most cases, physicians only need to give their patients the TUA
login information when filing a claim and then they are able to begin storing
and tracking electronically stored patient medical records.
Market Dynamics
Increasing
availability of eTMF is expected to propel growth of the electronic trial
master file (eTMF) market. For instance, in January 2021, Bioclinica, an
integrated solutions provider of clinical life science and technology
expertise, added eTMF as part of its CTMS offering. Moreover, increasing
adoption of eTMF is also expected to aid in growth of the market. For instance,
in November 2020, BetterLife Pharma Inc., a biotech company, selected Florence
Healthcare to provide its electronic Trial Master File (‘eTMF’) for the conduct
of the AP-003, its COVID-19 inhalation therapeutic trial. Similarly, in June
2019, Celltrion Healthcare, a biopharmaceutical company, adopted Veeva Vault
eTMF.
Emergence
of Covid-19 is expected to offer lucrative growth opportunities for players in
the electronic
trial master file (eTMF) market. For instance, globally, as of 5:15pm CET,
14 February 2021, there have been 108,153,741 confirmed cases of COVID-19,
including 2,381,295 deaths, as reported to the World Health Organization.
Among
regions, North America is expected to witness significant growth in the electronic
trial master file (eTMF) market, owing to increasing adoption of eTMF in the
region. For instance, in March 2019, PRC Clinical, a full-service CRO in the
U.S., adopted Veeva Vault in order to expand its eTMF capabilities.
Competitive Analysis
Major
players operating in the electronic trial master file (eTMF) market include, CareLex.org,
Paragon Solutions, Phlexglobal Ltd, SAFE-BioPharma Association, SterlingBio,
SureClinical, Montrium Inc., and Arivis AG, OASIS, Transperfect, Veeva Systems,
Vertmarkets, Inc., Mastercontrol, Inc., Florence Healthcare, and Advanstar
Communications, Inc.
Major
players operating in the electronic trial master file (eTMF) market are focused
on adopting partnership strategies to enhance their market share. For instance,
in September 2020, Phlexglobal announced successful creation and implementation
of the Global TMF Center of Excellence with partner PRA Health Sciences, a
contract research organization.
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