Faculty
Clinical Research
Paul Benninger has twenty years of global Clinical and Bioanalytical research experience in which the last 10 years have been in the pharmaceutical CRO sector. He has a complete hands-on experience in over 600 Phase 1/BE/BA studies, and over 50 single-centre Phase 2 and multi-centre Phase 3 clinical trials. During the past 10 years he has grown a privately held full service CRO from 6 employees to over 600 employees from Canada and US. Mr. Paul also has a significant regulatory compliance experience with all major regulatory agencies including the FDA, EMEA, TPD and ANVISA.He has been involved in numerous successful North American FDA and TPD inspection as well as providing independent auditing services for Indian CROs. In 2006 while under his leadership, Allied Research International was named one of the 50 Best Managed Companies in Canada.
Shweta Gujral - a dedicated, results-driven, and highly experienced Clinical Research professional with over 10+ years of expertise in clinical operations both nationally and internationally. As a GCP certified professional with an impressive track record in managing clinical trials and ensuring regulatory compliance has been instrumental in bringing numerous innovative drugs to market. With a strong attention to detail and ability to collaborate effectively with cross-functional teams, have consistently demonstrated exceptional leadership skills that enable me to drive successful outcomes.
I’ve extensive experience in designing and delivering training programs that are tailored to meet the needs of participants. With a passion for teaching, I’ve been instrumental in developing the skills and knowledge of numerous individuals in the clinical research industry. Specialize in providing comprehensive training for the sites to ensure that their facilities meet the rigorous standards set by the Joint Commission International (JCI) and Health Science Authority (HSA) inspections in Singapore.
Ability to simplify complex concepts has made me a favourite among trainees, friendly and approachable demeanor has made the learning experience enjoyable and effective. With a commitment to excellence and a wealth of knowledge in the field, I’m sure to provide team with the skills necessary to excel in the clinical research industry. With me at the helm, you can rest assured that your clinical research learning journey will be in the most capable and trustworthy hands..
Mr. Amit is an energetic professional with sound academic background in Bachelor of Pharmacy and Post Graduate Diploma in Clinical Research. He is a highly motivated, efficient Lean Six Sigma Green Belt certified professional with a total 14 years of work experience in life sciences domain.
Mr. Nakhe has hands on experience of new process start up, transition and process improvement projects. He also has successfully faced both external and internal audits and inspections (MPA, MHRA and USFDA) on various occasions.
He possess excellent communication and collaboration skills to lead and the ability to work in diverse groups effectively. He has performed roles like Process Executive and team lead.
He is currently working as a Faculty at CLINIMINDS (Institute of Health Sciences Training & Management) and is responsible for developing and updating training modules and content for Clinical research &pharmacovigilance, Delivering training programs etc.
Mr. Amit has been associated with Watson Pharma Pvt. Ltd. & Macleod’s Pharmaceuticals as a CRA and was responsible for coordinating clinical studies in CRO units.
He also worked for Tata Consultancy Services for approximately 10 years, managing large teams in Life Sciences Division with hands on experience in Pharmacovigilance/Patient Safety for 2 big pharma clients. He has worked on Sapphire (Patient safety database) and Argus.
Mrs. Soja Jacob, a post graduate in Biotechnology, is an enthusiastic Clinical research professional with 5+ years working experience.
Soja has experience in Clinical Research Coordination, administration and management and project management support. She has the ability to support and manage the tasks of multiple clinical research studies and has an excellent working knowledge on the site operations. Mrs. Jacob has extensive experience in managing multi-centric trials (Indian & Global) not limited to: Feasibility, start-up, Site selection, Initiation, Monitoring, Close-out, Budget approval, Sponsor & Site communication, patient recruitment & retention services.
She also has experience in the training of students who wish to work in the clinical research field. Soja has a creative and positive outlook and makes learning smooth, interactive and easy to remember.
She is an expert in SDV, CRF review, and managing site master files.
Soja also has experience in handling eCRF such as Medidata RAVE, Oracle RDC, Oracle Inform, Medrio EDC, Clinion etc. She possess thorough understanding of global regulatory requirements.
Soja has developed SOPs for sites. Achieved certificates in Good clinical practice and for EDC use.
Dr. Devesh is a seasoned clinical research professional and has successfully launched various organizations for different industries.
He is Meticulous, goal-oriented professional with hands on real time experience of End to End Clinical Trial Project Management, Data Management and Business Development for Clinical Trials. . Worked on more than 100 global and domestic trials and is an effective communicator with excellent relationship management skills, problem solving and organizational abilities.
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.
He is a medical graduate and posses post graduation diploma in clinical research and certification on FDA IND and NDA approval process from FDA smart. His immense vast experience of more than a decade in industry brings a variety to Thinki for all research processes and trials.
Pharmacovigilence
Senior Drug Safety Physician with over 7 years of pharmacovigilance and 3 years of clinical experience.
Periodic Benefit Risk Evaluation Reports (PBRERs)/ Periodic Safety Update Reports (PSURs); Periodic Adverse Drug Experience Reports (PADERs); Addendum to Clinical Overview (ACOs); Health Hazard Evaluations (HHEs)
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.
KULDEEP KINJA, completed his Bachelor of Pharmacy from M.D University, Rohtak after which he completed his Master in Pharmacy with Pharmacology from NIMS University, Jaipur.
He started his career with Wipro Ltd as Pharmacovigilance Officer in Drug Safety Department. He is having more than 8 years of industry experience in different Pharmacovigilance processes with global companies. He has expertise in end to end Pharmacovigilance processes, trainings, operations and people management such as collecting, handling and processing Individual case safety reports (ICSRs) in different safety databases like Argus, SafetyEasy along with MedDRA coding and narrative writing, aggregate reporting, signal detection, risk management plans, talent acquisition& backfill, maintenance of training files, liasoning for client training, preparation & maintenance of training plan & requisite material, Client & Business Reviews, Internal & External Audits, SOP (Standard Operating Procedure) & BCP (Business Continuity Plan) Management, Client Reverts & Observation Handling, deviation handling &CAPA (Corrective & Preventive Actions) closures, Bottom Quartile Management (BQM), Quality Initiatives, Reconciliation Reports & Invoicing, Calculation & Maintenance of CPMs (Critical Process Metrics), Shift & Roster Management, Attrition Management, Quality Initiatives, Lean and CI projects, preparing and reviewing documents like QMP, SOPs, WI, DMP etc in Pharmacovigilance, imparting training and preparing training materials, audits and inspections (readiness, handling and post audit/inspection response completions), regulatory guidelines, pre-sales and client mining.
He is currently working with Tenet Health Edutech Pvt. Ltd. as Pharmacovigilance Trainer and Consultant and his key responsibilities includes developing modules and training material on pharmacovigilance as per the ever evolving changes in regulatory and industry guidelines, delivering end to end pharmacovigilance training, participating in business development activities related to any opportunities in pharmacovigilance domain.
Mr. Amit is an energetic professional with sound academic background in Bachelor of Pharmacy and Post Graduate Diploma in Clinical Research. He is a highly motivated, efficient Lean Six Sigma Green Belt certified professional with a total 14 years of work experience in life sciences domain.
Mr. Nakhe has hands on experience of new process start up, transition and process improvement projects. He also has successfully faced both external and internal audits and inspections (MPA, MHRA and USFDA) on various occasions.
He possess excellent communication and collaboration skills to lead and the ability to work in diverse groups effectively. He has performed roles like Process Executive and team lead.
He is currently working as a Faculty at CLINIMINDS (Institute of Health Sciences Training & Management) and is responsible for developing and updating training modules and content for Clinical research &pharmacovigilance, Delivering training programs etc.
Mr. Amit has been associated with Watson Pharma Pvt. Ltd. & Macleod’s Pharmaceuticals as a CRA and was responsible for coordinating clinical studies in CRO units.
He also worked for Tata Consultancy Services for approximately 10 years, managing large teams in Life Sciences Division with hands on experience in Pharmacovigilance/Patient Safety for 2 big pharma clients. He has worked on Sapphire (Patient safety database) and Argus.
Clinical Data Management And eTMF
Mr. Amit is an energetic professional with sound academic background in Bachelor of Pharmacy and Post Graduate Diploma in Clinical Research. He is a highly motivated, efficient Lean Six Sigma Green Belt certified professional with a total 14 years of work experience in life sciences domain.
Mr. Nakhe has hands on experience of new process start up, transition and process improvement projects. He also has successfully faced both external and internal audits and inspections (MPA, MHRA and USFDA) on various occasions.
He possess excellent communication and collaboration skills to lead and the ability to work in diverse groups effectively. He has performed roles like Process Executive and team lead.
He is currently working as a Faculty at CLINIMINDS (Institute of Health Sciences Training & Management) and is responsible for developing and updating training modules and content for Clinical research &pharmacovigilance, Delivering training programs etc.
Mr. Amit has been associated with Watson Pharma Pvt. Ltd. & Macleod’s Pharmaceuticals as a CRA and was responsible for coordinating clinical studies in CRO units.
He also worked for Tata Consultancy Services for approximately 10 years, managing large teams in Life Sciences Division with hands on experience in Pharmacovigilance/Patient Safety for 2 big pharma clients. He has worked on Sapphire (Patient safety database) and Argus.
Shweta Gujral - a dedicated, results-driven, and highly experienced Clinical Research professional with over 10+ years of expertise in clinical operations both nationally and internationally. As a GCP certified professional with an impressive track record in managing clinical trials and ensuring regulatory compliance has been instrumental in bringing numerous innovative drugs to market. With a strong attention to detail and ability to collaborate effectively with cross-functional teams, have consistently demonstrated exceptional leadership skills that enable me to drive successful outcomes.
I’ve extensive experience in designing and delivering training programs that are tailored to meet the needs of participants. With a passion for teaching, I’ve been instrumental in developing the skills and knowledge of numerous individuals in the clinical research industry. Specialize in providing comprehensive training for the sites to ensure that their facilities meet the rigorous standards set by the Joint Commission International (JCI) and Health Science Authority (HSA) inspections in Singapore.
Ability to simplify complex concepts has made me a favourite among trainees, friendly and approachable demeanor has made the learning experience enjoyable and effective. With a commitment to excellence and a wealth of knowledge in the field, I’m sure to provide team with the skills necessary to excel in the clinical research industry. With me at the helm, you can rest assured that your clinical research learning journey will be in the most capable and trustworthy hands..
Medical Affairs
Dr. Sandeep Bhatia is Medical Affairs & Clinical Development leader with 15 years of Pharmaceutical experience.
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.
Hands on experience of various facets of healthcare sector have proven his entrepreneurial skills and now he is a Medical Director & Senior Partner in Think-I as first generation entrepreneur.
By qualification Dr Sandeep Bhatia is a trained ENT and Head & Neck Surgeon and has clinical & surgical experience in Oncology.
Strengths : Ideation, Strategic, Achiever & Restorative.
Pharma Business Analytics
Rajesh R. has 14+ years of experience in Healthcare/Lifesciences Management consulting (Business Analytics, HEOR, Competitive Intelligence, Forecasting, Sales Force Effectiveness and Market Research) in healthcare and pharmaceutical industry including with leading business analytics and pharmaceutical companies.
He has hands-on experience of working with Top 15 global pharmaceutical companies in the areas of Competitive Intelligence and Market Research. He has been key in business development efforts in the pharma consulting domain.
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.
Dr. Sheikh is a Medical Graduate and Masters in Public Health (Health policy, Economics and Finance).
He has vast experience of Health Economics both in working for State Health (Government) and Global MNC Pharmaceuticals.
His Areas of Expertise:
Health Economics
Health Financing
Health Policy and Planning and Analysis
Health Systems Research
Epidemiology, Biostatistics
Disease Modelling
R Programming language
Medical Writing
Dr. Sood completed his Medical Graduation (MBBS) from AIIMS, New Delhi in 1978 & Master’s in General Surgery (M.S.) from AIIMS, New Delhi in 1982.
Dr. Sood comes with strong academic background. Some of his past positions are
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.
Biostatistics
Dr. Sood completed his Medical Graduation (MBBS) from AIIMS, New Delhi in 1978 & Master’s in General Surgery (M.S.) from AIIMS, New Delhi in 1982.
Dr. Sood comes with strong academic background. Some of his past positions are:
Professor of Surgery, Faculty of Medicine, Universiti Teknologi MARA, Shah Alam, Selangor, and Consultant, Department of Surgery, Hospital Selayang, Malaysia.
Reader, Department of Surgery, University College of Medical Sciences and Guru Teg Bahadur Hospital, New Delhi
Professor, Department of Surgery and Head of Gastrointestinal Surgery services, Himalayan Institute of Medical Sciences, Dehradun, India.
