Visiting Faculty

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.

A keen strategist with the ability to understand and articulate key opportunities in ever changing research industry. He has great proficiency in planning, organizing, executing & training subordinates on protocol based management and conduct of clinical trials.

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.

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.

A keen strategist with the ability to understand and articulate key opportunities in ever changing research industry. He has great proficiency in planning, organizing, executing & training subordinates on protocol based management and conduct of clinical trials.

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.

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).

A keen strategist with the ability to understand and articulate key opportunities in ever changing research industry. He has great proficiency in planning, organizing, executing & training subordinates on protocol based management and conduct of clinical trials.

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)

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.

Experienced in Case Analysis for Ad Hoc reports and Surveillance Analysis of Non Spontaneous Safety Data for PharmacoVigilance (SNAP)

Experienced in Case Analysis for Ad Hoc reports and Surveillance Analysis of Non Spontaneous Safety Data for PharmacoVigilance (SNAP)

Experienced in conducting medical review of PBRERs/PSURs, PADERs, HHEs, Ad Hoc Reports, SNAP and Safety Management Team (SMT) Slides which includes checking the case for overall medical cohesiveness, checking the expectedness of adverse events, adding company causality and company comments

Trained in Monthly Signal Reports and Drug Abuse Report for FDA

Maintaining a knowledge of the AE safety profile of assigned drugs, Reference Safety Information documents, aggregate reporting conventions and guidelines, clients’ procedures and international drug safety regulations. Maintaining an awareness of global regulatory reporting obligations.

Experienced in conducting medical review of PBRERs/PSURs, which includes checking the case for overall medical cohesiveness, checking the expectedness of adverse events, adding company causality and company comments.

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.

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.

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.

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 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.

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.

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.

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.

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).

He has developed keen interest in ever evolving Life Sciences & Healthcare technology and business landscape and how it can be leveraged to improve commercialization and consolidation for pharma players. Conducted several domestic and international workshops.

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