Dr. Bhaumik Mody is a medical professional with post-graduation in Clinical Research and Regulatory Affairs. He has a decade of experience with reputed pharmaceutical companies and CROs like Sun Pharma, Cadila Pharma, LAMDA, Synchron and GVK. During his industry association, he has achieved substantial experience in Phase I-IV clinical trials, BA/BE studies, PK/PD studies and managing clinical supplies distribution. He has managed large teams comprised of medical writing, CRA, data management, pharmacy professionals.

• Managed more than 200 BA/BE studies including 70 studies as a PI/CI and successfully faced DCGI, ANVISA and MOH Turkey site audits as well as EMEA, WHO and USFDA study specific audits.
• Managed clinical trials (Phase I – IV) in Oncology, Psychiatry, Infectious diseases, Cardiology, Dermatology, Endocrinology and Vaccines for drugs, biologics and medical devices. (comprising 22 studies with collective sample size of around 9000)
• Managed PD studies for eye drops, lipid lowering drug, proton pump inhibitor and anti-obesity drug. Managed patient based PK studies in Psychiatry and Infectious diseases.
• 350+ auditing and monitoring visits including CRO selection visits, Investigator site feasibility/selection visit, CRO/site pre-study monitoring visits, during study monitoring visit, dosing inspections/observations etc.
• 40+ training sessions including GCP, regulatory guidelines and updates, Good documentation practises, safety reporting and requirements etc.

He possesses exemplary skills in Regulatory affairs in India and fully updated on US-FDA and EMEA regulations. He has vast experience in handling all regulatory documentation, new drug applications, abbreviated new drug applications, IND/NDAC/MDAC/SEC committee meeting presentations along with excellent medical writing skills.

Charmin is an experienced clinical research professional with an edge over the Quality Assurance. After graduation from science stream, he did his post-graduation in Organic Chemistry from Gujarat University. In order to get into the depth of the subject and achieve excellence, he also pursued post-graduation in clinical research after his industry association.

He has a work experience of more than 08 years working with leading CROs like Cliantha Research Pvt. Ltd. (Earlier known as BA resaerch) and Accutest Research Laboratory Pvt. Ltd. As QA personnel, he played a vital role in facing regulatory/sponsor audits during this tenure. He has faced all major regulatory audits like USFDA (03), WHO (01), ANVISA Charmin has a wide experience of BA/BE studies with active involvement in more than 300 studies. His major part of involvement in all these studies was In-process audits. (ICF and Screening related activities, eligibility check, compliance to study procedures as per the SOPs, Protocol and applicable regulatory requirements etc.). He has observed more than 500 dosing, including dermatology studies like patch application and cream application. He has a rich experience in system set-up, periodic internal system audits and updation, as required.

Some of the Job functions he has handled till date are:

• Preparation and development of Clinical Research and Quality Assurance SOPs,Working Manual, Master Audit Plan
• Review of Study Documents such as Protocol, CRF, ICF/PIS, CRF enclosures and CSR
• Compliance assessment of various trials related activities/documentation with respect to SOPs, study protocol and different regulatory guidelines/regulations
• Site preparation for Regulatory Inspections
• Supervise the Control and issuance of Clinical Trial study documents and SOPs
• Verification of resolved Data Clarification Forms prior to Database lock
• Verification of Raw data generated by Data management prior to statistical Analysis Quality Management of Clinical Research Systems/Studies
• Planning and Execution of Clinical Research Audits Facing Regulatory Inspections/External Audits
• SOP Reviews (Clinical Trials and BA/BE)
• Training of study staff in GCP, SOPs and study protocol
• Regulatory Inspection/Certification Preparation
• Preparation of response letter to queries generated in regulatory/sponsor audits
• Investigator Site/Vendor Audits
• Project Specific Audits
• System/Internal Audits
• BA/BE study Audits
• GCP/GLP compliance assessment

Dr. Deepak Patil is a medical professional with clinical experience as a general physician before assuming the role of medical advisor at Sun Pharmaceuticals. Through his expertise in medico-marketing, he has been able to integrate his prior roles to achieve successful launch of several new products in the fields of Urology and Infertility medicine. Currently furthering his skill set at the esteemed Boston University, USA, he will now include healthcare information systems and management to his profile in the coming months.