About Us

CLINEXEL is a full-service Clinical Research Organization. We provide clinical research, clinical development, regulatory affairs, medical writing and pharmacovigilance services. Our Clients include companies with their innovations (new chemical entities & biologicals) in early clinical development phase, small/ mid-size pharma and biotechnology companies with niche products and medical device companies focused on complying with new EU Medical Device Regulations.

CLINEXEL Management includes professionals with experience in leadership positions in pharmabiotech companies. Extensive experience and technical expertise of our technical leaders coupled with their hands on experience in key positions in pharma companies enables us to provide customized, efficient, regulatory compliant and cost-effective solutions to our Clients. Passion and hard work of the team enables us to consistently deliver great results for our Clients.

We are providing services to companies based in India, USA, Italy, Germany, UK, Singapore and Canada. 60 percent of our business is exports.

Clinical Trials Project Management & Monitoring services

CLINEXEL Project Managers ensure efficient Project Management and experienced CRAs provide high quality monitoring services

Regulatory Approvals

We are providing global clinico-regulatory services for development of new chemical entities and biologicals. 

 

We support companies by preparing clinical development plans and regulatory strategies and further firming up these through pre-IND and scientific advice meetings. We are also working on subsequent IND projects for Life Cycle Management of pharmaceuticals

 

Pharmacovigilance

We are conducting end to end PV operations for multiple Pharma companies for the US FDA and India compliance,  including ICSR (case) processing, PBRERs, literature monitoring, signal detection, RMP and evaluation of additional PV activities and RMM measures.

Global Clinical Trials

We provide Global solutions for CLINEXEL clients through world-wide clinical trials.

 

CLINEXEL is a member of Association of International Clinical Research Organizations (AICROS) www.aicros.com. Through AICROS, we can provide clinical trial sites in 4 continents and over 80 countries.

Medical Devices

We conduct Pilot & Pivotal clinical investigations for medical devices. We are conducting Post Marketing Clinical Follow-up (PMCF) studies for marketed devices. We are preparing CEPs and CERs for our clients. to support CE marking.

CLINEXEL team has experience with following devices- stents, ventilators, intraocular lens, respiratory devices, orthopaedic devices, electromagnetic radiation emitting devices, sutures and gloves.

Our Experts

WE are a team of committed and talented professional include pharmaceutical physicians and pharmacists, clinical research professionals, expert clinicians and medical writers.

 

With an extensive 150+ years of cumulative industry experience in handling time sensitive projects Strong Project Management & quality review.


Our Team consists of high performing professional management team led by experts from the Industry.

 

Our Team

MBBS , MD

Director Of Clinexel

Dr Deepa Arora is the Founder & Director of the CLINEXEL. She is a physician (MBBS, MD) and served

MBBS , MD

Senior Medical Expert

Dr Sajid is a Physician with 20+ years of experience in safety monitoring and pharmacovigilance. He has experience in

PGD (Systems Management- DCM and DSM)

Head – Clinical Data Management & Biostatistics

Mr Toraskar has more than 25 years of experience in clinical data management. He has previously worked with leading

Masters in Pharmacy (M. Pharm- Pharmacology)

Head- Clinical Research

Head- Clinical Research Nilesh is a Clinical Research Professional with 10+years of experience in clinical trials in Phase 2,

Masters in Pharmacy, Ph.D (Pharmaceutical Medicine)

Head- Medical & Safety Writing

Dr Madhuri is a Doctorate with strong knowledge and understanding of clinical research, pharmacovigilance and project management. Madhuri has

Masters in Microbiology (M. Sc)

Head-Quality Assurance & Training

Nabid is a Quality Professional with 10+ years of experience in quality assurance and clinical monitoring. Nabid has experience

Masters in Pharmacy (M. Pharm- New Drug Delivery Systems), PG Diploma in Patent Law

Head- Regulatory Affairs

Shivani is a Pharmacist with experience of working with CDSCO (Competent Authority (CA)/ Central Licensing Authority in India) as

B. Pharm

Manager- Pharmacovigilance

Pharmacist with 11 years of Pharmacovigilance experience in the industry. Managing various Pharmacovigilance activities for  Pharma and medical device