Your Trusted Partner For Clinical Research and Pharmacovigilance

About Us

CLINEXEL is Clinical Research Organization providing Clinical Development, Clinical Operations, Medical Writting, and post marketing Pharmacovigilance services to pharma, biotech and medical device companies. We are a team of commited and talented professional include pharmaceutical physicians ans pharmacists, clinical research professional, expert clinicians and medical writers with 100+ years cumulative industry experience.

Clinical Trials Project Management & Monitoring services

Clinical trial project planning including feasibility assessment, developement of regulatory strategy and financial planning plannning .

Selection of countries and clinical trial applications to competent Authorities for approval .

Vendor selection and logistic management.

Site selection and qualification .

EC dossiers preparation, submission and approvals

Strategic planning for logistics- central lap selection and clinical trial supplies

Patient Recruitment Strategies .

Investigator contract development and grant negotiation

Site Set-up

DSMB set-up

Regulatory Affairs

Regulatory consulting and strategic services

Preparation of clinical development plan

Preparation of pre-IND meeting dossier, including list of relevant question and facilitating pre-IND meetings and scientific advice meetings

Filing of Clinical Trial Application

Subsequent IND Applications for new formulation/ indications.

Regulatory compliance and gap analysis

Development of package inserts and update

Development of package inserts and update

Regulatory writing services .

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 forĀ  Pharma and medical device

22+

Health Section

146

Different Services

388+

Blood Donation

1280

Satisfied Patients