Clinical Development Services Agency

CLINICAL TRIALS TOOLKIT UPCOMING TRAINING

Who we are?

The Clinical Development Services Agency (CDSA) functions as an academic research unit established to facilitate the development of new drugs, treatment regimes, and affordable healthcare products. It aims to develop an ecosystem that supports the design, planning, and delivery of large-scale multi-centre clinical trials/cohort studies across a varied portfolio of clinical specialties. The unit works with public sector institutions and small and medium enterprises (SMEs) to translate innovative technologies and new drugs into medical products.

CDSA was launched on 28 September 2009 as an extramural unit of Translational Health Science and Technology Institute (THSTI) by the Department of Biotechnology (DBT), Ministry of Science and Technology.

What We Do?

Clinical Trial/ Study Design and Analysis

Regulatory Science and Policy Support

Resources to Support Clinical Research
Clinical Trials Toolkit
Research Application Platform – CReATE
Good Clinical Practice Professional Certification Scheme (GCPPCS)

Projects - Studies & Trials

Neosepsis Study

Sepsis-related mortality among neonates in India - A multi-disciplinary, multi-institutional research

MISSION COVID Suraksha

Enhancing capacity for conduct of human clinical trials for COVID-19 vaccine candidates

INDIGO

A program to develop and evaluate an effective and affordable flu vaccine for the world.

Hospital Network Study

A prospective nationwide study to understand the clinical course, severity, risk factors and outcomes of

GARBH-INI

Garbh-INI – Interdisciplinary Group for Advanced Research on BirtH outcomes – DBT INdia Initiative (PTB)

Zn Sepsis Study

An RCT for evaluating zinc as an adjunct for the treatment of clinical severe infection in infants younger than 2…

INVICTUS Study

INVestIgation of rheumatiC AF Treatment Using vitamin K antagonists, rivaroxaban or aspirin Studies

BEAT India TB Study

Evaluation of the efficacy and safety of a combination regimen of Bedaquiline, Delamanid, Linezolid and

ADBS

Accelerator program for discovery in brain disorders using stem cells:integrating clinical

POD TB Vaccine

A three arm, double-blind placebo controlled randomized trial to evaluate the efficacy and safety of two

iKMC – ND Study

The follow-up study to evaluate the impact of continuous KMC initiated immediately after

District Hospital Study

Burden of multidrug-resistant neonatal sepsis in district hospital settings in India

Dengue TRC

Translational Research Consortium for Establishing Platform Technologies to Support Prophylactic and

NBM

An academia-industry collaborative mission for accelerating discovery research to early

Digoxin

This is a multi-centre, double blind placebo-controlled, parallel-group randomized trial of digoxin

Biostatistics Workshop from 20-22 Dec 2023

A three-day Statistics in Clinical Trials workshop was conducted at the Translational Health Science and Technology Institute from December 20-22,… Read More

National Workshop on Regulatory Compliance for Accelerating Innovations

CDSA along with DBT, BIRAC, CDSCO conducted its fifth among the six national workshops on regulatory compliance for accelerating innovations… Read More

CDSA supports launch of ICMR TB vaccine trial for healthy…

This is the first-ever government led vaccine trial after the BCG vaccine trial that was undertaken decades ago. After a… Read More

National Workshop on Regulatory Compliance for Accelerating Innovations, May 29,…

CDSA along with DBT, BIRAC, CDSCO conducted its fourth among the six national workshops on regulatory compliance for accelerating innovations… Read More

Training Courses

CDSA and C-CAMP co-host National workshop on regulatory compliance for…

The Department of Biotechnology (DBT) and Central Drugs Standard Control Organisation (CDSCO) along with Biotechnology… Read More

CDSA organizes GCP and GCLP programs at ICMR Headquarters

CDSA conducted Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP) programs at the… Read More

Study Investigator Meeting held on 13th-15th April 2019 at Kigali,…

Population Health Research Institute (PHRI, Canada) organized a global Investigators Meeting on 13th-15th April 2019… Read More

Short Course on Research Methodology

Clinical Development Services Agency (CDSA), an extramural unit of Translational Health Sciences and Technology Institute… Read More