Director and Head – Operations
S D Rajendran holds a doctoral degree in Pharmacy with specialization in Clinical Pharmacology. He has about four decades of service spanning over Academia and Clinical research. He has earlier held positions including Head of Medical Affairs division of Sristek Clinical Research Solutions Pvt Ltd., Hyderabad and Associate Vice-President and Head of Operations of Par Biosciences Pvt Ltd (a unit of Endo International, Ireland).
He is currently serving as the Head of Operations at Scitus since October 2017. In his career in the clinical research industry, he has conducted 10+ clinical trials in various therapeutic areas including Oncology, Pain Management, Psychiatry, Cardiology, Dermatology, Pulmonology, Vaccines and Immunology. In addition, he has conducted 300+ bioavailability and bioequivalence studies in healthy volunteers.
Head – Clinical Operations
Dr. Senthil Kumar holds an MD in Pharmacology. He comes with more than 13 years of experience in the field of Clinical Research including BA/BE Studies and phase trials. He has been the investigator for more than 200 studies, and has successfully faced DCGI, US-FDA, WHO and EMA, and many more regulatory inspections in his tenure. He is associated with Scitus from 2019 onwards.
Head – Bioanalytical / Analytical
Karthik Rajendran has 19 years of vast experience in the Bioanalytical field. He is a Doctorate with a specialization in Pharmaceutical analysis with post graduate in Master of Pharmacy in Pharmaceutical
Chemistry and has technical and scientific expertise in Analytical and Bioanalytical research. He has publications in peer-reviewed journals like Bioanalysis, Current Pharmaceutical Analysis etc.
Prior to Scitus he was associated with Apotex Research Pvt Ltd and GVK Bioscience. He has been working with Scitus since its inception as Head of the Bioanalytical and Analytical department.
Has established a Center of Excellence bioanalytical and analytical facility in Scitus Pharma Services
Private Limited. Has hands-on experience with quantitative analysis of molecules in complex
biological matrices such as plasma, serum, whole blood and complex bioanalytical methods for
Hormones, steroids, and endogenous molecules using LC-MS/MS. Had developed and validated 450+
molecules. Has experience developing and validating nitrosamine, nitrosamine drug substance related
and genotoxic impurity using LC-MS/MS, Elemental analysis in drug substance, biological matrix,
excipients etc., using ICPMS. Have faced several successful audits from all regulated markets like
USFDA, MHRA, EMA, TPD (Health Canada), TGA and GCC.
Head – Quality Assurance
Prakash R holds an MSc in Biochemistry. He comes with over 18 years of experience in the Pharma and Clinical Research Industry, and looks after the GCP, GLP, and GVP Quality Assurance unit operation.
Prakash has a successful proven track record for handling various regulatory audits like USFDA, EU, MHRA, ANVISA, NPRA, etc. He has been associated with SCITUS since Feb 2022.
Prior to Scitus, he was with Syngene International Ltd, Axis Clinicals Ltd, Endo International Inc., Cliantha Research Ltd, etc.
Prakash leads the Quality Assurance units (GCP.GLP and GVP) and he will be the person for strengthening and improving our quality culture at SCITUS.