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.
Kamal Shahani is an MBA, with over 21 years of experience in the field of healthcare,
pharma and clinical research industry. Before establishing Cliniminds and Mediminds,
he was heading an international CRO Allied Research International - Cetero, North
America in India and at the same time working with ARI’s international operations
in United States and Canada and was directly involved in setting up the CRO and
central reference lab in Miami, Florida. He has also worked for Gribbles Pathology
Australia and Dr. Lal PathLabs on the senior management positions, and established
and managed over 15 nationally and internationally accredited laboratories. For
the last 4 years he has been involved in developing and managing international level
educational and training programs in the field of Clinical Research and other healthcare
management areas, and has established one of the largest and most reputed network
for clinical research education and training. He is also an international business
consultant and Director on the board of various international healthcare and clinical
research companies. He has been nominated on the Editorial Board of Journal for
Clinical Studies, published from U.K.
Dr. Darshana Purohit has completed her MBBS from Mumbai, has a Masters in Hospital
Administration(MHA) from New Jersey, USA and is a Certified IRB Professional (CIP).
She has worked in the Clinical Research industry for close to 9 years in the USA
at Newark Beth Israel Medical Center, a leading research and teaching hospital in
NJ. She has been the single point of contact for all research regulatory requirements
for the US FDA, OHRP, JCAHO and ICH GCP for the medical center. She has been the
lead internal auditor and trainer for all clinical trials that were performed at
the medical Center. She has been involved with corporate SOP writing for research
administration for multicenter clinical trials, financial decision making and budgeting.
She has extensive experience in teaching clinical research to medical, nursing students,
medical residents, physicians and medical fellows in conducting a clinical trial
as per ICH-GCP guidelines, JCAHO, US FDA and OHRP. She has assisted in designing
clinical trials for investigator initiated trials, guided in regulatory submission
to the IRB and FDA. Her range of research experience includes cardiac, cardiac transplant,
oncology, pediatric oncology, critical care medicine, pulmonary medicine, sleep
disorders, etc. She has also taught at the University of Pune for their Clinical
Research and Data Management program before joining Cliniminds.
Dr J Vijay Venkatraman is an allopathic doctor with specialization in Diabetology.
He also has a MBA degree in Services Management to his credit. He has worked in
the Pharmaceutical industry as Drug Safety (Pharmacovigilance) Physician and Clinical
Research Physician in leading multinational organizations like Accenture and ICON
Clinical Research.
He has performed medical review of more than 5000 adverse events and serious adverse
events. He has accumulated expertise in working on ARISg and other drug safety databases.
He has worked extensively in Literature Adverse Drug Reaction Search. He served
as medical monitor for clinical trials during which he gained project management
experience also. He is a subject matter expert in Diabetology and has published
in national & international journals.
Dr J Vijay Venkatraman teaches Pharmacovigilance and Clinical Research to students
and industry professionals. He has also served as a guide for students’ projects.
He had the opportunity to visit the head offices of various leading multinational
pharmaceutical companies during his trip to Germany.
Integrating his knowledge and experience from both the Academia and the Industry
perspectives, he is now a Consultant Pharmacovigilance Physician based at Coimbatore.
He heads the operations of the Tamil Nadu & Puducherry regions of Cliniminds (www.cliniminds.com),
India's largest Clinical Research Training Academy. He is a faculty at Cliniminds
as well.
Dr J Vijay Venkatraman is also a practising Diabetologist at Diab-at-ease Clinik,
which is located in the premises of KTVR Group Hospital (
www.ktvr.com),
of which he is a Director. He is also the Consultant in Pharma Domain for Rated
Profiles (
www.ratedprofiles.com), a unique
comprehensive career management portal.
Dr. Satesh Shekhar as a qualified physician with B.H.M.S degree and having approximately
5 years of experience in pharmacovigilance, phase 1 , phase 2 and Phase 3 trials.
He has been with prestigious organizations like Johnson and Johnson and lambda Therapeutic
research and specializes in medical writing and Pharmacovigilance. He has Prepared
and assisted in the database/pharmacovigilance activities required for the smooth
conduct of the operations. Also he has authored protocols for various bioavailability
/ bioequivalence trials, phase trials including submission trials (countries where
the trial submitted: UK, USA, Canada, Australia).
He graduated from the University of Delhi and went on to complete Masters in Clinical
Research and then an Advanced Diploma in Clinical Research management. He has undergone
GCP certification from Academy of Clinical excellence, Mumbai. Also obtained an
IATA Certification for handling Biological Samples in clinical trials.
Carrying an Experience of more than 3 years and being a part of 12 Oncology trials
with different indications at a centre in Bhopal, he has hands on experience in
managing trials, handling patients, preparing tracks, handling sponsor’s communication,
handling and facing audits and regulatory inspections. He has been with Cliniminds
since past 2 years and has guided and mentored students to achieve their proficiency
in courses that they are currently doing.