CLINICAL TRIALS CENTERS
Introduction:
The clinical trial centres are involved in the conduct of Clinical Trials
for investigational new drug product development, from Phase I through
Phase IV. The Clinical Trials /studies are planned and conducted, developed
in accordance with ICH-GCP regulations and ethical requirements, and
involve Regulatory Submissions, Medical Writing, Clinical Trial Management,
Clinical Trial Monitoring, Data Management, and Quality Assurance.
The centres are responsible for designing, approving and completion of
clinical trials of new drugs. The CSIR-CDRI deals with the preparation of
dossiers for investigational new drug (IND) applications, including the
clinical trial protocol, investigator brochure, case record forms, and
informed consent documents. It is also responsible for filing applications,
interacting with regulatory agencies, solving queries, and obtaining
clinical trial permissions. The division has NABL-Quality council of India
accredited facility for haematology and biochemistry testing and an ethics
committee at CDRI Jankipuram Extension, Lucknow campus.
Facilities:
The institute has set up of Phase 1 clinical trial at King George Medical
University, Lucknow, Seth G.S. Medical College and, KEM Hospital Mumbai
& PGIMER Chandigarh. The phase 2, 3 & post-marketing studies are
conducted at various hospitals in the country based on the site selection
and site feasibility assessments.
Some recent regulatory, clinical trials of CDRI molecules conducted/planned
at these centres are as follows.
A. King George Medical University (KGMU), Lucknow:
1) The phase 3, Randomized, Parallel Group, Placebo-Controlled Trial of the
hepatoprotective effect of picroliv in patients receiving multi-drug
therapy of tuberculosis.
2) Phase 3, Randomized, Double-blind, Placebo control trial of Efficacy,
Safety and Tolerability of Antiviral drug Umifenovir vs Standard care of
therapy in non-severe COVID-19 patients.
3) A Phase 1, Randomized, Single-blind, Placebo-Controlled, Single dose
& Multiple Ascending Dose, Safety, Tolerability and Pharmacokinetics
Study of Bone Fracture Healing CDRI Compound S007-1500 in Healthy
Volunteers.
B. Seth G.S. Medical College and KEM Hospital Mumbai
1) A Phase 1, Randomized, Single-blind, Placebo-Controlled, Single dose
& Multiple Ascending Dose, Safety, Tolerability and Pharmacokinetics
Study of Novel antiplatelet CDRI compound S007-867 in Healthy Volunteers.
C. PGIMER Chandigarh.
1. A Phase 1, Randomized, Single-blind, Placebo-Controlled, Single dose
& Multiple Ascending Dose, Safety, Tolerability and Pharmacokinetics
Study of Novel antiplatelet CDRI compound 97/78 in Healthy Volunteers.
Contact us
Dr Vivek Vidyadhar Bhosale, M.B.B.S., M.D. Pharmacology
Principal Scientist, CSIR-Central Drug Research Institute,
Sector 10, Jankipuram Extension, Sitapur Road, Lucknow 226031, Uttar
Pradesh, INDIA
Phone: +91-522-2772487 Email:
drvivekbhosale[AT]cdri.res.in