Dr. Prashant Kirkire

Founder and leader of a specialized biometrics and regulatory data CRO focused on delivering high-quality statistical, programming, and data standards solutions to global pharmaceutical and biotechnology companies. At Eupraxia Life Sciences, I lead a multidisciplinary team supporting sponsors across the clinical development lifecycle, with a strong emphasis on biostatistics, CDISC standards, SEND datasets, and regulatory-ready analytics aligned with global regulatory expectations including US FDA, MHRA, PMDA, and EMA. Our work helps organizations transform complex clinical and non-clinical data into clear, submission-ready evidence that enables confident regulatory decisions and efficient drug development. Key areas of focus include: • Biostatistics and statistical programming for clinical and preclinical studies • CDISC implementation including SDTM, ADaM, and SEND datasets • Regulatory submission datasets and integrated summaries • Clinical data management and standards implementation • Real-world data analytics and evidence generation • Biometrics strategy for pharmaceutical and medical device programs Under my leadership, Eupraxia has evolved as a trusted niche biometrics partner for sponsors seeking deep expertise in regulatory data standards, statistical methodology, and compliant data environments. We operate within validated computing ecosystems using SAS, R/Pharmaverse, and Python, and maintain strict adherence to global regulatory and quality frameworks including ICH E6/E9, CDISC standards, and 21 CFR Part 11 compliant environments. Our mission remains simple: “Impactful decisions need data clarity.”

This is the honorary position for the period of two years. The objectives and the activities of this council can be studied at the ISCR website www.iscr.org.

Karmic Lifescineces LLP is a Cliantha company.

inVentiv Health, Inc., offering best-in-class clinical, consulting and commercial services to the healthcare industry, has completed the acquisition of i3, a top-tier contract research organization (CRO) to the pharmaceutical, biotech and medical device industries. i3 was previously owned by Ingenix, a UnitedHealth Group company. The new combined legal entity was called inVentiv International Pharma Services Ltd.in India, and globally, inVentivHealth, although in the interim period it was labelled as PharmaNet/i3.

I set up i3statprobe organization in India with 50 ex-Pfizerites from DevOps, Mumbai, The organization soon became full-fledged CRO providing end-to-end clinical research services - the organization was more known as i3 as i3statprobe, i3 research, i3pharma resourcing and i3 drugsafety organizations were set up under one umbrella. The i3 organization rose to 450+ headcount by mid-2011 having its offices in Mumbai, Pune, Hyderabad and Gurgaon. The organization was globally taken over by inVentivHealth in Jan 2011.

The Pfizer Pharmaceutical India Pvt. Ltd. (PPIPL) was a Pfizer Global R&D (PGRD) India site.

I headed team of market research and sales force analytics in India.

As Head of R&D, I worked for all the JV organizations such as IMS (Health sector known as ORG-IMS in India), ORG-GfK. I also enjoyed my additional role as Member of Technical Committee for Asia-Pacific Region and specifically headed innovations in Census Operations in Asia-Pacific countries.

My role largely involved working on nation wide studies of health policies, reforms, developmental-strategy formulations for the Bilateral and Multilateral funding agencies including The World Bank, USAID, UNDP, Asian Development Bank. The role involved heading a team of research professionals based at 8 metro cities of India.