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Inside Cliniminds


Our Pharmacovigilance Training
Partner
think-i
Key Senior Honorary Visiting Faculty Members

G. A. Bhorkar
• 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.

Mrs. R. Begum
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
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. R. Prabhu
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.

B. Ganesh
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
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. V. Singh
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. S. Kulkarni
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
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)




Mr. Kantabhukta
He is a Post graduate in Medicinal Chemistry comes and comes with a good experience in case processing of individual case safety reports. He has varied experience in carrying out Pharmacovigilance activities like triage of incoming cases to determine seriousness for prioritization of daily workflow, processing of cases, medical coding and Narrative writing for investigational and marketed medicinal products.
He has over 4 years of experience in pharmacovigilance and regulatory industry and is currently working as submission reviewer. His responsibilities include perform/oversight safety regulatory reporting (ICSR's) in all major regions.

Mr. Mrutyunjay
He is a result oriented health care professional holding a degree of Post Graduate in Pharmacy. He has a rigorous experience of over 8 years in the areas of Pharmacovigilance and Clinical Trials and has worked for reputed companies like ICON, Synowledge and IQVIA.
He has extensive expertise in case processing and quality reviewing of ICSRs, knowledgeable on global Pharmacovigilance reporting methods (single report/aggregate report) execution of PVA's and process error investigations.
He has worked on the major therapeutic areas like Nephrology, Immunology (biologics), Oncology and vaccines for Drug safety operations.
Mr. Mrutunjay also possesses strong expertise on GVP modules and ICH guidelines for Pharmacovigilance.

Mrs. Salma F.
She is a seasoned professional with overall experience of approximately 9 years in the industry with good exposure to Clinical Research, Pharmacovigilance and Data Management.
She has handled different software like EDC, Oracle Clinical, Oracle AERS, ArisG, Percieve etc.
She has expertise in Narrative writing for multiple clinical trial studies (Renal, Oncology, vaccines etc.) and has worked for industry giants like Quintiles and Accenture.

Ms. Najmun
Ms. Najmun possess more than 9 years of experience in Clinical Research and Pharmacovigilance domain and has worked for companies like Accenture, Synowledge and Quintiles.
She has extensive experience in processing and reviewing clinical trial & Post Marketing cases ranging from a wide therapeutic area (Oncology, CNS, CVS, Acute Inflammatory, Infectious diseases).
She also has expertise in protocol designing and safety monitoring of clinical trials from Phase I to Phase IV.

Ms. M. Morusupalli
Ms. Morusupalli, a Post graduate in Pharmaceutical sciences comes, with a good experience in case processing of individual case safety reports.
Ms. Morusupalli has varied experience in carrying out Pharmacovigilance activities like literature searches, Preparation of deviation memo, Database searches, Registry and Triage of incoming cases to determine seriousness for prioritization of daily workflow, request translations as required (forward to LMD as appropriate) and Narrative writing for different trials.

M. Mathew
Ms. Mathew is a meticulous and highly accomplished professional with extensive experience in Drug safety.
Her core competency is in case processing of individual case safety reports including follow up of adverse drug reactions. She is also responsible for quality checks of ADR reports received from regional hospital for quality & accuracy.
Ms. Mathew also has experience in conducting hands on training workshops and CMEs on pharmacovigilance. She possess experience in using Vigiflow.

Mr. Bairagi
Mr. Bairagi comes with 8+ years of experience in pharmacovigilance operations. His experience includes but not limited to ICSRs identification and processing, Quality review of ICSRs, Training and mentoring.
He has working experience on various databases like ARGUS, ARISg, IRMS, eCTD, GDMS, and SPS etc.
Mr. Bairagi is well experienced in facing client audits and SOP preparation. He was involved in the review serious adverse experience (SAE) reports received from Investigator sites and adverse experiences (AEs) from post marketing sources.
Mr. Bairagi was also part of the Quality review team and was engaged in performing quality control checks of completed individual safety reports to ensure compliance with regulatory reporting requirements. He also has brief knowledge of medical coding, medical writing and clinical data management.

Dr. R Kumar - Senior Consultant – Pharmacovigilance

Dr. Kumar is MBBS & MD in Pharmacology having demonstrated the ability to lead diverse activities of Pharmacovigilance and Clinical Research.
Nineteen plus(19+) years of hands-on experience in strategic planning, attainment of quality and financial standards, budget preparation, and overall coordination of Global Pharmacovigilance and Clinical Research operations.
Implemented, Validated and Established global safety databases like ARGUS, ARISg for Multiple Global Pharma organizations. Developed from scratch, an E2B compliant end to end safety databases like PvNET and IPS (Proprietary safety database of TCS).
He has worked with several global organizations on Senior Pharmacovigilance positions, including Global Pharmacovigilance Head, Cognizant Technologies; Vice President Lambda Therapeutics; Group Leader – Pharmacovigilance, Ranbaxy; Head Global Pharmacovigilance at Aurobindo and Panacea.



Mrs. Stephy
Mrs. Stephy is an experienced professional with more than 3 years of experience in data management and over 1 year experience in clinical research. In her current role she performs quality review of SAS data sets and reconciliation of data
Prior to her role in data management she managed clinical trials from start up to close out stage for various indications and has a sound knowledge of ICH GCP and Indian regulatory environment.

S. Ali
Ms. Ali is a young, enthusiastic data management professional with more than 4 years of working experience in the domain. She has thorough knowledge and specialisation in different activities with study setup,maintenance and conduct phases in different databases.
She has a good command over discrepancy management and data cleaning activities and has extensive exposure of clinical databases Rave, Oracle Clinical, Inform 4.6 and Inform 5.5
She comes with vast experience in different Clinical Research Therapeutic Areas including Oncology, Alzheimer, Antidepressant studies, Rheumatoid Arthritis, Malignant Breast Tumour, Ulcerative Colitis, Allergy, HIV Infection etc.


Mr. Lokesh
Mr. Lokesh is a meticulous, goal-oriented, experienced data management professional with over 5 years of experience in the domain with a strong commitment to the field of research.
He also has a hard core experience in the field pf Clinical Research with thorough understanding & knowledge in Clinical Operations, Site Operations and regulatory process. He also supports eTMF department and is well versed with end to end processing of documents.
He bears the skill set to ensure high quality data and on-time completion of complex projects.


Mr. Balakrishnan
He is a result oriented professional with rigorous experience of over 13 years in the areas of Clinical Research and Data Management. He is presently spearheading as a Protocol Data Manager. Prior to his role as a Manager he was the Lead Data Manager for NIH-International Centers for Excellence in Research.
He has an excellent skill set in managing clinical trial data and providing data management support to Clinical Operations, data management & Biostatistics team.
Mr. Balakrishnan has extensive knowledge in all areas of research including budgeting, GCP, IRB, Submissions & Safety reporting.



Dr. S. Gupta
Life Sciences and Healthcare Management Consultant with 11 years of experience in pharma business analytics and clinical research Industry. Worked at managerial positions in leading pharma consulting companies like WNS Global Services and Smart Analyst Private Limited, expertise in competitive intelligence, epidemiology, current treatment landscapes, clinical trial analysis, pipeline analysis, primary and secondary market research, oncology conference coverages, pharma shots, company page profiling and hands-on experience on clinical databases like Pharmaprojects, Trial Trove, Adisinsight, Medline, PubMed, Clinicaltrials.gov, EudraCT, Japic clinical trials.
Subject matter expert for Oncology, Immuno-Oncology therapy area with knowledge of various solid tumors and Hematological malignancies. Expertise in planning, quality check, end to end client deliveries along with team management, project management and client engagement skills.
Masters and Bachelors in Pharmaceutical Sciences from DIPSAR, Delhi University along with completion of post graduate courses in Pharmaceutical Drug Regulatory Affairs (Jamia Hamdard), Clinical Research and Patents.

S. Kumar - Consultant HEOR
Experience of working on global drug pricing and market access projects. Particularly price forecasting and its evolution, HEOR analysis and its assessment, price audit for products  and Annual cost calculation.
Overall 7 years’ experience in research analytics and academics. Have experience in HTA project with Indian council medical research (ICMR) and academics experience at Post Graduate Department of Actuarial Science and Department of Economics (Research).
He has ability to create cost effectiveness model using Markov or decision tree with the help of excel, budget impact analysis & sub-group analysis with probability sensitivity calculation (simulation), forecasting claim and price variation, pricing, and insurance premium & reserve calculation.
He is Post Graduate in Actuarial Sciences and Graduate in Mathematics with Statistics.


Deepti Goel - GCP Auditor & QA Consultant
An M.Pharm (Pharmacology) by training with over 15 years’ experience in Clinical Research specializing in the areas of Project Management, Quality Management, GCP / GxP Audits, Sponsor liaising, People Management, GCP and regulatory training, Site training and development, SOPs creation and up gradation etc. Worked with leading Indian and multinational companies viz. Clintec, Cliniminds, CRQA, Cytespace, Panacea Biotec.
Experience in the following therapeutic areas - Dermatology, Oncology (Breast Cancer, Hodgkin’s (NHL), Colorectal cancer, Rheumatoid Arthritis, Pain Management, Hemorrhoids, Dermatology, Pulmonology( Upper Respiratory Tract Infections).


Ms. Bhaswati Mukherjee - Consultant - Biostatistician
A PhD statistician with more than 13 years of overall experience in statistical research, university teaching, data analysis, data interpretation and report writing. Expertise in:
Protocol Inputs
Sample Size Calculation
Simulation
Statistical Modeling
Survival Analysis
Supporting DSMB related activities
Writing Statistical Analysis Plans and Creating Mock Shells
Exploratory Analyses
Bayesian Statistics
SAS and R programming Languages
Training Expertise:
Extensive training experience in Basis as well as Advanced Statistics and R programming
+91-9910068241
+91-9560102589
+91-9810068241
Google Reviews

vaishnavi rathor
Stars Hi.. I am Vaishnavi I have done m.sc microbiology recently i have joined clinical research and clinical data management course in Cliniminds and got placed in an MNC as a CRC. ...more

Atul bishnoi
Stars I have done B. Pharma and after completion of graduation. I went to cliniminds for PG diploma in Clinical research and Pharmacovigilance. ...more

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Dr. Sandeep Bhatia
Medical Director & Senior Partner – Healthcare & Life Sciences
Dr. Sandeep Bhatia is Medical Affairs & Clinical Development leader with 15 years of Pharmaceutical and clinical research experience. Dr.Sandeep Bhatia
Dr Sandeep has worked extensively in field of Oncology Medical Affairs and headed Medical Affairs department for Global Pharmaceutical companies. He was the Head of Oncology Medical Affairs for MSD India and also led Medical Affairs team for Roche, India. Apart from this he has gained significant experience by working in companies like Novartis , Sanofi & Mylan.Read More...
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