Dr. Gaekwad is Professor and Ex-Head, Department of Pharmaceutical Sciences, Nagpur
University. He has extensive experience in the teaching and pharmaceutical research.
He was earlier the Professor and Head of DIPSR. He is currently on the Board of
Directors of several leading pharmaceutical companies.
He is Group Lead - Pharmacovigilance, Panacea Biotech Ltd. He has more than 8 years
of experience in Clinical research and has undergone training in France on EMEA
regulatory requirements, Roles and Responsibility of QPPV (European Union etc.).
Ashwani Pandita is working with Reliance Clinical Research Services (RCRS), Mumbai
as Head-Quality Assurance. He has obtained his Masters in Quality Management from
Birla Institute of Technology and Science (BITS) Pilani, with his Bachelor’s in
Pharmacy from Nagpur University. He has an experience of more than 9 years in Quality
Assurance. As a global auditor for Reliance, he has performed several clinical trial
audits in India, Turkey, UK, and other parts of Europe. His audit expertise includes
investigator site audits, vendor audits, clinical laboratory audits and system audits.
Additionally, he has an experience of hosting several inspections including USFDA
inspections and EMEA inspections.
At Reliance, Ashwani is also responsible for the training of clinical research staff
on various aspects of clinical trials and GCP. He has been an invited speaker at
various GCP workshops and Clinical Research Training Courses in the country.
Ashwani is also associated with Clinical Trial Magnifier, Hong Kong as an Advisory
Ashwani has joined Reliance in August 2005 and prior to joining Reliance, he was
associated with pharmaceutical companies like Cadila Pharmaceuticals, Ipca Laboratories
and US Vitamins.
Dr Naveen is a Certified Clinical Research Associate (CCRA) from the Association
of Clinical Research Professionals (ACRP) and a pharmacologist (Ph.D.) by education
with broad experience of around 9 years together in Clinical Research as well as
academics for drug development processes.
He continued his career at ICON Clinical Research as a Clinical Research Physician
and have accumulated three years of industry and academic experience to my credit.
While at ICON, he handled the tasks of a Medical Monitor as well as those of a Project
Manager, along with the responsibilities of a Pharmacovigilance Physician. He now
function as a consultant physician and trainer in Pharmacovigilance, and currently
heads Cliniminds in Tamil Nadu, India.
He is specializing in the areas of Sponsor liaising and budget negotiations, along
with clinical study set up (Phase I-IV), Project Management, Training of CRAs with
co-monitoring visits, SOPs creation, Medical Writing, GCP-Audits of sites and vendor
In his current position he is the Manager-QA (Clinical Trials) at Veeda Oncology
(VON) and is responsible for formulating training strategies for operations team.
He is currently working in Lead position in Clinical data management at i3 ( a unit
of United Health Group). Prior to this, he has an extensive experience in CDM at
Gayatri has 5.5 years experience in Clinical Data Management [ includes leading
projects, creation of eCRF specification, Functional review of the data base, functional
review of the edit checks, creation of Data Validation Specification, Data Validation,
coordinate with the team throughout the cycle of the study on EDC/Paper studies]
and other experience in Data processing. In her past assignment, she has worked
as Clinical Data Manager in PAREXEL International Ltd., Hyderabad and also as a
Quality Assessor with Accenture Services Pvt. Ltd., Bangalore
He post graduated from prestigious Georgia Southern University, USA majoring in
Biostatistics. Also completed his internship at prestigious Curtis Anderson Memorial
Cancer Research Center, Savannah Georgia under guidance of renowned geneticist Dr.
Dominique Broccoli. He has a clinical research experience of 4 years in USA working
mostly on SAS and SPSS softwares in Biostatistics & Data Management. Currently he
is working as Biostatistician in people’s hospital in Bhopal, M.P.
He is currently working as a Biostatistician – Fortis Clinical Research Ltd., Faridabad
with total experience of more than three and half year in the Clinical and statistical
research. He was a Jr. Biostatistician – Biometrics in CliniRx Research Pvt. Ltd.,
Gurgaon for more than 1 year.
Dr. Ashish Indani is a medical doctor with over 6 years of experience as clinical
research professional in the field of medical devices. He has strong understanding
of global medical device regulatory environment. He has worked for several global
medical devices companies, and currently working with Biosensors International.
He is the senior visiting faculty at Cliniminds by special invitation.
He has an overall 6 years of experience in clinical research and marketing, working
with Pharma companies and CRO’s. By Training, he is an B.Pharm, MBA with specialization
in Marketing and is certified CRA from ACRP, USA. Also he has completed PG Diploma
in Clinical Research from Bombay College of Pharmacy, Mumbai. He has worked across
various clinical research verticals including bioequivalence trials, Phase II, III
and IV trials. He has monitored, managed projects, mentored teams and trained clinical
research professionals. As a monitor he has prepared many sites for inspections
and faced many internal and external audits. He has conducted various training programmes
for internal team on Basic and advanced GCP and related issues.
In his current assignment he is the Faculty cum centre manager at Cliniminds and
is responsible for oversight of operations and training needs and development of
Cliniminds across Maharashtra, India. He is responsible for all academic related
plans, tasks and activities for all courses offered by Cliniminds.
Dr.Jayasimha.M.S has over 4.5 years of experience in clinical research working with
Hospitals, Pharma companies, CRO, Labs and training academy. By Training, he is
BDS with specialization in Dental Science. As Clinical Research Coordinator he was
involved in Maintaining Site Master Files, Drug accountability. Patients dosing,
Collecting pk samples, Paper CRF and e-CRF completion, Ethics Committee submissions,
Electronic data capturing and entry. He has handled more than 25 Trials and 15 Trials
Independently. He was also a Sub Principal Investigator for one of the Trial. He
was also involved in various clinical activities including ensuring protocol compliance
for all the events and the procedures, Attending Investigator meeting & Site training
meeting, Assessment of inclusion & exclusion criteria, Participation in informing
the patients about clinical trials, Participation in obtaining informed consent,
evaluating patient status for safety and assure optimum health care.
PhD is a pharma professional with 14 years of industry experience including 9 years in clinical research and 5 years in project management of NCE preclinical & clinical development. She is skilled in conducting ICH-GCP and Schedule Y of Indian Drugs and Cosmetics Act governing clinical trials. She has extensive experience in managing multicentric trials across India, Asian and African countries. She has worked in Ranbaxy Research Laboratories, Pharmacia (Pfizer) and LG Life Sciences in multicultural environment.
She has also been a visiting faculty at Jamia Hamdard University, Delhi where she has taken lectures for post-graduate students of clinical research.
At Ranbaxy, she lead the clinical development of Synriam, an antimalarial – India’s first new drug which was launched in 2012. She has received various awards for demonstrating commitment and contribution in clinical research. She was recently felicitated by the former President of India, Dr. A.P.J. Kalam for exceptional contribution in development of Synriam.
A result oriented Clinical Research Co-ordinator with 1.5 years of experience in
Clinical Trials. She has Lead one PHASE-III Diabetic trial and co-ordinated PHASE
IV & PHASE III Dibetic trials, PHASE III Ulcerative Colitis Trial and PHASE III
H1N1 Pediatric Trial. She has an expertise in preparing subject file, preparing
trial master file, documentation of trial procedures, doing IVRS/IWRS, filling eCRF
and paper CRF, reporting AE and SAE, conducting trial in adherence to protocol.
She is trained in ICH-GCP Guidelines. In Cliniminds She is working as an Academic
Coordinator and in involved in training students theoretically and also providing
practical hands on experience.