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Experts see Indian clinical research as critical enabler driven by qualified workforce, regulatory support & tech implementation

Nandita Vijay, Bengaluru
Thursday, May 26, 2022, 08:00 Hrs  [IST]

Experts sees Indian clinical research as critical enabler driven by qualified workforce and regulatory support. This makes the sector much sought-after for pharmacy students armed with technology know-how to take up clinical research as a lucrative career option providing growth opportunities for candidates.

According to Akshay Daftary, director, SIRO Clinpharm, over the last few years, India has made spectacular progress in healthcare and life sciences, with clinical research serving as a critical enabler.

Highly skilled professional ecosystem and proactive approach to innovation has allowed India to emerge as a powerhouse for clinical research-led healthcare advancements. The Indian clinical research landscape is expanding at a healthy rate, with an increase in the inflow of clinical trials and foreign sponsors demonstrating their trust in India, he added.

The large and diverse population, experienced investigators, and credible clinical research organizations make it an ideal destination for clinical trials. The regulatory and ongoing support from government agencies have helped to sustain and promote growth in this sector, said Daftary.

On the occasion of the International Clinical Trials Day observed annually on May 20, the College of Pharmaceutical Sciences, Dayanand Sagar University, Bengaluru along with the Indian Society for Clinical Research (ISCR) and the Karnataka Registered Pharmacists Association led by Dr Kaushik Devaraju organized a workshop titled Evolving Career Perspectives in clinical trials in line with ICH, GCP and R3 guidelines.

The experts led by Dr Gaurav Mathur, senior director regulatory affairs, Parexel International and chairperson, South Chapter ISCR focused on clinical operations, quality, regulatory, pharmacovigilance, medical writing, data management and technology.

Dr. Maseera Iram, Senior Principal Medical Writer, Allucent (Legacy Pharm-Olam LLC) said that medical writing is an art of creating well-articulated documents. Writing for regulatory submissions needed to clear and concise to get approval for drugs, devices, and biologics educational medical writing focused on drug-related educational and propagative literature, journal manuscripts and healthcare websites.

Ami Shah director and co-founder, SperaMed Consulting provided a peek into career growth path in clinical monitoring/clinical operations. Dr Anuradha HV Professor & Head, Dept. of Pharmacology, MS Ramaiah Medical College, Bengaluru highlighted the clinical research avenues in academia where candidates could be employed as clinical research coordinator clinical pharmacist faculty and as a guide for research.

Highlighting the indispensability of digital technology applications in clinical research was Swetha Khokale, sr director, business operations services, Advarra, who stated that platforms like CTMS, EDC, eTMF, eSource, e-Consent, integrated site solutions, RBM, medical review platforms, sponsor site integrated solutions, ePROs, eCOA, DDC were valuable.

Quoting the Novartis Research of June 2020 she said 72% of technology professionals were more likely to consider working in pharma as compared to six months prior. Covid-19 set an example for how digital technology can improve the clinical research experience for researchers, patients, and physicians. Decentralized trials are now widely adopted much faster than expected, and by all indications, and here to stay. The jobs to look out covered analytical, support, implementation, project management. Even biostatisticians could apply their statistics skills and extensive knowledge to draw meaningful conclusions from clinical trial data.

 

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