Company

Director – Clinical Data Standards, Novartis

Personal Information

Tushar Sakpal is Director – Clinical Data Standards – Novartis . He is currently responsible for end to end global clinical standards management including, data acquisition (CRFs & non CRFs), eDC build, edit checks, SDTM, ADaM, TFL and other global metadata concepts. He also represents Novartis in global forums and consortiums discussing standards and automation related strategies.

Tushar brings in 22 years of Clinical Development expertise with prior experience in TCS, PharmaNet (now Syneos), Pfizer, GE Capital, Reliance Life Sciences and Siro ClinPharm. Prior to joining Novartis, he worked with TCS for 9.5 years in delivering Biostatistics and Statistical Programming services across global Pharma. Also, he was closely involved with the technology team for developing platforms / tools for clinical domain in Data Management, Statistical Programing and Biostatistics space, which included MDR based platform for storing global metadata and SDTM transformations. He has good understanding of CDISC guidelines, Policy 70 requirements, eSubmission
package requirement, EudraCT / CT.Gov requirements.