Biostatistics

Dr N S Narasimha Murthy – M.Sc, PhD – Statistics

Dr. Murthy is one of the renowned personalities in the field of Biostatistics. He has been a part of various Clinical Research Organizations and currently working as Professor of Biostatistics, Dept. of Community Medicine – SIMSRC, Bangalore. He is also a senior consultant for Anusandhana Statistical Solutions, Bangalore. Dr. Murthy has been associated with Sapthagiri Clintrac Pvt Ltd since 1 year and is the lead Biostatistician with abundant knowledge in various statistical tools like Win online, SAS etc.

Clinical Operation and Business Development

Mr. K. Thomas – MBA, HDSE and PG Diploma in Clinical Research

Clinical Operations and Business Development Head with more than 9 years’ experience in working with AERAS Global Vaccine Foundation in US, Research Council of Norway, And IPHCR. Also having experience of 6 years working as COO of Corporate Hospitals. Expertise in Clinical Research, Clinical Operations, Project Management and Monitoring and Business development. Experiences in coordination of all phases of global and domestic Clinical Trial activity in India, experience includes Protocol Development, designing and reviewing clinical trial related SOPs, Clinical Study documents and CRF. Designing SOPs for Ethics Committees, budgeting for Clinical Trials. He is responsible for generating business outside of existing key accounts. Therapeutic Clinical Trial experience with phase II, III, IV and CT-BA/BE, Drugs, Herbal and Nutraceuticals trials includes:-Diabetes, Oncology (Lung Cancer and Breast), Orthopaedics (Rheumatoid arthritis, OA knee, Osteoarthritis, Post-operative pain management) , Pulmonology (Asthma & Tuberculosis Vaccine trials),Dermatology(Psoriasis), OBG trials( HP Vaccine Study),Cardiology, Nephrology(Anaemia associated with CKD),ENT(Allergic Rhinitis) Surgery- Haemorrhoids, Metabolic Syndrome ,Irritable bowel syndrome, Weight loss, Dyspepsia, Food product trials ,Infection studies including HIV. Also experienced in handling Device and Diagnostic trials.

Medical writing and Regulatory affairs

Dr. Girish H.R MBBS, MD (Orthopaedics)-Director Medical writing

He is a person holding master’s degree in Orthopaedics from Calicut University; subsequently he accomplished his Clinical & Research fellowship in Hip & Knee Arthroplasty and DNB Orthopaedics from Ajou University School of Medicine, South Korea and NBE, New Delhi respectively. He has clinical Research experience as a Principal Investigator and Co-Investigator of many clinical trials in the field of Orthopaedics and Rheumatoid arthritis. He contributed his knowledge to Sapthagiri Clintrac by designing, composing and implementing new protocols, procedures, manuals, user guides and training materials, as well as ensuring that they are following Good Laboratory Practices guidelines and regulations and also assisted in the writing of papers published in scientific journals. His major publications are “The ideal position of hip lag screw within the femoral head: based on micro-CT analysis of the trabecular structure of the femoral head”, “Minimally invasive surgical technique for the treatment of complex tibia condyle fractures: A prospective clinical study” published in Journal of Research in Orthopaedics and Sports Medicine. Currently he is working as an Associate Professor in Sapthagiri Institute of Medical Science & Research Centre.

Dr. Aswini.K.V MBBS, MS (Opthal)-Medical writer

She has Master’s in Ophthalmology from Rajiv Gandhi University of health Sciences. She started her career as Consultant doctor; later on she gained extensive experience by working in various hospitals in various roles and also she worked as a Principal Investigator for Bioequivalence clinical study in the indication of Cataract Surgery. Experience in various domains like Regulatory Medical Writing, R&D, Clinical practice, Pharmacovigilance Key skills: CSR, Protocol, ICF, IND, CDP, DSUR, PSUR, and Narrative Writing. She is responsible for writing clinical study reports for various phases and Therapeutic area. Facilitated meetings related to a documentation review and approval of documents. Associate Professor in Sapthagiri Institute of Medical Science & Research Centre.

BA BE Studies

Dr. Raghunandan. R .MBBS.MD (Pharmacology): Investigator –BABE Clinical Studies

He is holding Post Graduate Pharmacology degree from Rajiv Gandhi University of health Sciences .he is Clinical Investigator responsible for conducting BABE studies he over sees initiation, execution and completion of projects for Clintrac clients; and ensuring delivery is within time and budget. Potentially oversee multiple projects and responsible for process implementation and ensure process compliance. He is Responsible for creating or updating the SOPs, or other process related documents as per project specific requirements Identifies and pursues business development leads and opportunities with support from Clintrac leadership ,experience and expertise in drafting and review of regulatory documents (protocol design synopsis, full protocols, clinical study report, informed consent, IB, eCTD),