Dr. Sandeep Singh is Vice President – Clinical Operations at CBCC Global Research. By qualification, he is a Medical graduate with Post Graduate Diploma in Clinical Research and has about 20 years of illustrious clinical trial experience.
He started his career in 2002 as a Medical practitioner. He joined industry in 2005 and worked as Cardiology Associate for one of the premier global CRO i.e. Iqvia (Formerly known as Quintiles). In Iqvia he was part of QECG lab and was responsible for QTc studies of global clinical trials.
He later joined Alkem Laboratories Limited, Mumbai in 2007 and worked as Sub-Investigator. His role was pivotal in obtaining maiden ANVISA certification for Alkem and executing submission studies for USFDA and EMA.
He later joined Unichem Laboratories Limited, Mumbai in 2009 as Deputy Manager – Clinical Research. He worked with Unichem for 6 years, earned two promotions and got relieved in 2015 as Senior Manager – Clinical Research. He was instrumental in building separate Clinical Research and Biopharmaceutics team and execution of BE studies for USFDA, EMA, ANVISA and emerging markets. He worked very closely with departments like patent, formulation development, analytical, Regulatory affairs on subjects like Biopharmaceutics, BCS based biowaiver, IVIVC etc.
Before joining CBCC, his immediate last assignment was Head – Biopharmaceutics and Project Management at Veeda Clinical Research. He joined Veeda in 2015 and worked for 1.5 years. He was instrumental in building separate Biopharmaceutics team and execution of BE studies for USFDA, EMA, ANVISA and emerging markets. He was responsible for study designing, Data evaluation, Project Management, Regulatory Affairs Protocol Writing, Report Writing, Quality Control, Pharmacokinetics and Biostatistics. He was also heading CRAMS department.
Dr. Sandeep Singh has rich experience in conducting BE studies for Regulated Markets, IVIVC, Biopharmaceutics, Generic Product Development Strategy, Bio-waiver strategy, Bridging Studies, Statistical Methodology, adaptive Clinical Study designs etc. He also had hands-on experience as a Clinical Investigator in BA/BE studies, Phase-1 Clinical trials and in ECG analysis, Interpretation & Digitalization. He had managed Outpatient departments during his active Medical Practice prior to joining Pharmaceutical Industry. He has remarkable experience in interacting with various Regulatory Authorities like USFDA, EMA, ANVISA, HPFB Canada, TGA etc.
