• Mr. Bhorkar comes with a rich experience of over 11 years in the pharma industry, which includes approx. 6.5 years in Clinical Research and 4.5 years in pharmacovigilance
He has a good knowledge of Regulatory Authorities of different countries and ICH guidelines.
His areas of expertise include Clinical Trial operations, Risk Based Monitoring, Centralized Monitoring, CTD, eCTD, pharmacovigilance and Analytics.
She is an enthusiastic Clinical Research professional having more than 7 years of experience in Clinical Research Industry. She holds a M.Sc. in Biotechnology and Advanced Certification in Clinical Research.
She comes with a good experience in Clinical Research working for reputed companies like Manipal Ecron Acunova, GVK Bioscience, ICON Clinical Research and IQVIA and has handled the Operations activities, eTMF and Data management.
Mr. Modh is a clinical research professional with strong educational background offering 5+ years of experience in Clinical Research Coordination, administration, remote site monitoring, RBM and management and project management support.
An expert in liaising between different departments, he has the ability to support and manage the tasks of multiple clinical research studies. He also possesses special talent for maintain databases, CTMS, eTMF and good analytical skills with dashboards reports for remote data monitoring.
He has handled trials of various indications like Ophthalmology, Respiratory & Infectious disease, Oncology & Ophthalmology. Prior to VCLS, he worked as Senior Project Assistant in PPD for 4 years.
Dr. Prabhu is an experienced &qualified medical professional holding a BHMS degree and post doctorate in Medical Pharmacology. He has extensive 9 years of experience in pre-clinical and clinical research, Pharmacovigilance, Medical Writing & Data Management. He possess thorough understanding of global regulatory requirements.
He has experience in major therapeutic areas like dermatology, infections, diabetes, asthma, schizophrenia, ophthalmology etc.
Dr. Prabhu has a creative and positive outlook and makes learning smooth, interactive and easy to remember.
He has 20 international publications to his credit and has worked in clinical trials as Principal Investigator.
Dr. Prabhu has been awarded with Best research Project-IACR, Greece, Europe.
He is a goal-oriented, high-energy enthusiastic professional who excels in challenging and competitive environment. He holds a Master’s in Biotechnology.
Mr. Ganesh comes with a vast experience of 10 years in the Clinical Research domain working for diverse companies like ICON, Micro-therapeutics, Apollo Hospitals, Cosmopolitan Medical Centre etc.
Prior to his role as BD Manager he was responsible for managing Clinical Operations Project Team and has extensive experience in managing multi-centric trials not limited to: Feasibility, start-up, Site selection, Initiation, Monitoring, Close-out, Budget approval, Sponsor & Site communication, patient recruitment & retention services. He has experience in Endocrinology (Diabetes, Diabetic Foot Ulcer, and Diabetic Nephropathy), Cardiovascular (Hypertension, Pulmonary Hypertension, Congestive Heart Failure, and deep Vein Thrombosis), Pulmonology (COPD, pulmonary embolism).
He has a strong knowledge of ICH-GCP and is well versed with different clinical tools (Oracle Clinical, RDC, Veeva vault-eTMF, Inform etc.
He has also successfully faced both FDA & DCGI audits.
Ms. Ganga is an experienced &qualified professional with extensive 9 years of experience in the field of clinical research with thorough understanding & knowledge about clinical operations, Site Operations, Patient Recruitment and Document Management.
She possess thorough understanding of global regulatory requirements.
Ms. Ganga has experience in using tools like Clinphone IVRS/IWRS, Rave,EDC etc.
Ms. Ganga is an experienced &qualified professional with extensive 9 years of experience in the field of clinical research with thorough understanding & knowledge about clinical operations, Site Operations, Patient Recruitment and Document Management.
She possess thorough understanding of global regulatory requirements.
Ms. Ganga has experience in using tools like Clinphone IVRS/IWRS, Rave,EDC etc.
Mr. Kulkarni is a clinical research professional with around 8 years of experience with expertise of Study Development, Study Conduct and Study Close out phase of trial. He has worked for reputed companies like SIRO Clinpharm, Quintiles, Glenmark and PPD.
He hascore experience in Clinical Operations with a sound knowledge of all National & Global regulations.
He has experience in handling a range of trials on therapeutic areas like Nephrology, Ophthalmology, Oncology, Infections/parasitic diseases, Dermatology, Circulatory, Respiratory, Musculoskeletal and Endocrine.
He possesses proven abilities to work effectively with internal and external stakeholders and to liaise with key opinion leaders.
Ms. Khurana is a globaldrug associate with extensive 8 years of experience in RMP, Eudravigilance, literature screening & review, Medical information system & Medical Writing.
She is a subject matter expert on aggregate reports and an excellent corporate trainer. She has Drafted and reviewed various regulatory reports like Periodic adverse drug experience report (PADER), Periodic safety update report (PSUR), Periodic Benefit Risk Evaluation Reports (PBRER), Addendum to Clinical Overview (ACO) and developmental safety update report (DSUR).
She has knowledge of ICH guidelines for ICH E2C (R2) guidelines, and Guideline on GoodPharmacovigilance practices (GVP) Modules.
Ms. Khurana has working knowledge of ARISg and Argus database (Pharmacovigilance and Safety software)