Clinical trial programming is changing. For decades SAS was the only language that counted in statistical programming, but the industry is now moving decisively toward open-source tools, with R at the front. Global pharmaceutical companies and CROs are building their programming pipelines in R, the pharmaverse ecosystem now offers purpose-built, industry-backed packages for SDTM, ADaM and TLF generation, and the R Consortium's pilot submissions to the FDA have shown that R-based regulatory submission packages are a practical reality. For clinical research professionals, this creates both a skills gap and an opportunity. Sponsors and CROs increasingly look for programmers who can work across both SAS and R, and data managers, biostatisticians, medical writers and clinical research professionals who understand R can analyse, question and present trial data with far greater independence. This program is built to take participants from their first line of R code to a complete, submission-oriented clinical trial programming workflow, aligned with CDISC standards and global regulatory expectations.
Speakers :
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Mr. Kamal Shahani, Founder & Managing Director, Tenet Health Edutech Pvt. Ltd. is a senior business leader and consultant in medical devices, healthcare, life sciences, clinical research, and pharmacovigilance, with over 35 years of experience in these sectors. He is the Founder and Managing Director of Cliniminds, an institute focused on medical devices, clinical research, pharmacovigilance, and related training and education programs, and has played an influential role in developing skill-based programs and business education in the industry. He is also a Founder of Think-i CRO and CRQA, a leading GxP compliance firm.
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Kritika Singh, Biostatistician is a Biostatistics professional with strong expertise in clinical trials, pharmacokinetics (PK), and bioequivalence (BE) analysis, supporting end-to-end statistical activities from study design through regulatory submissions. Extensive experience in PK data interpretation, bioequivalence statistical evaluation, and regulatory-focused analysis, with the ability to translate complex statistical outputs into meaningful, decision-oriented insights.
Who should attend this webinar?
- Clinical Research and Clinical Data Management professionals.
- Pharma, Life Sciences and Healthcare working professionals.
- Pharmacy graduates and postgraduates; B.Sc., M.Sc., BDS, BHMS, BAMS, MBBS; Biotechnology and Biomedical Engineering graduates and postgraduates; Life Sciences graduates and postgraduates.
For more information, please feel free to contact us at +91 9560102589
You may also write to us at info@cliniminds.com
