Clinical Research – Clinical Research in India
Clinical research is an inseparable part of drug development and discovery process. Owing to the modern lifestyle,
there has been an increase in new age ailments round the globe. Simultaneously, with the presence of innovative
diagnostic methods today any disease is detected at an early stage. Keeping these aspects in mind, eminent
biophrama companies in India in association with numerous medical institutions and hospitals are investing in
innovative drugs with an intention to cure chronic diseases. Therefore, today clinical trials has a greater
prominence than before, with India making significant contributions.
In terms of medical innovations, places in the southern part of the country have outshined others. In the recent
past, India has been considered as a prime center for clinical research owing to its vast patient pool and qualified
clinic research professionals and able doctors. Places such as Bangalore, Vellore, and Chennai have eminent Clinical
Research Organizations (CRO) offering a portfolio of services that spans across Phase I to III studies for global
biotechnology and pharmaceutical companies. These CRO’s specialize in various aspects of clinical research having
expertise in areas such as Medical Writing, Regulatory Services, Biometrics, Bioanalytical Research and many
others.
Medical writing gained its prominence in the pharmaceutical sphere as the industry soon identified the need of
special skills to produce comprehensive medical documents where the information has to be presented in a clear
and precise manner. All leading CRO’s in India have an experienced Medical Writing team, that guarantee all
submission documents are medically and scientifically accurate, concise and complies with all regulatory and ICH
guidelines. The submission reports are generally in CTD and eCTD formats. The services consist of Investigation
Brochures, Case Report Forms, Study Reports, Scientific Papers for publication, Med Xview for e filing and many
more.
Regulatory Services along with QA form the essential constituents of service portfolio at the top CRO’s. They have
a separate team for audit and regulatory compliance that is backed by an extensive understanding of regulatory
methods and the successful connection with different regulatory agencies, assures competence in the clinical trial
approval process. Selected service includes compiling the clinical trial application, formulating regulatory services,
responding to regulatory queries and safety reporting.
Bioanalytical Services forms the forte of certain CRO’s in India and they cover a wide array of activities such as
serum, blood, urine, plasma and the ability to evaluate intricate modules for Phase I plasma sample from Oncology
assignments. Similarly, CRO’s consists of Biometrics team assisting clients at all levels of Clinical Trials with the
know-how to develop analysis method, interpretations, study designs and help in clinical development program.
The teams use upgraded software such as SAS and Winonline for their research and studies.
With the rise of clinical trials conducted in India, the future of clinical research appears bright and flourishing.
Positive clinical trial results will make the economy thrive, as a single successful molecule will result in potential
buyers to shell out millions in India as well as abroad.
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