CDSA – CDSA

Welcome to Clinical Development Services Agency

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Who we are?

Department of Biotechnology (DBT), Ministry of Science & Technology, Government of India launched CDSA on 28 September 2009 as an extramural unit of Translational Health Science & Technology Institute (THSTI). It was created to facilitate development of affordable healthcare products for public health diseases. Registered as a not-for profit research organization, it aims to develop an eco-system for training and learning and work with public sector institutions, and small and medium enterprises (SME) to translate innovative technologies into medical products for public good.

More about us

Our Mission

To create, develop and nurture world-class clinical product development capacity in India.

EXPERTISE DOMAINS

Ethical requirements (clinical trial)

Ethical requirements (clinical trial)

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Good Laboratory Practice (GLP)

Good Laboratory Practice (GLP)

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Good Clinical Laboratory Practices (GCLP)

Good Clinical Laboratory Practices (GCLP)

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Good Clinical Practice (GCP)

Good Clinical Practice (GCP)

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Services
we offer

Technical Advisory

CDSA provides technical advice and/ or support to investigators/clinical researchers and SMEs for planning and conduct of the research project with special emphasis on operational aspect, tracking for milestones, risk identification and management for efficient implementation of research proposal, data management. Additionally we have capability of contributing to scientific review...

Clinical Data Management

CDSA has robust processes and data capture systems that ensure reliable data quality and an audit trail. The clinical data management system at CDSA is installed in a secure and validated IT environment and provides the following customized data management services on the platform: Development of data management plan e-CRF...

Project Management

CDSA offers project management services to support and assist investigators/clinical researchers and SMEs. This includes developing project management plan, site set up, project launch,  study execution, final report and closure of the study. The  primary challenge of project management is to achieve all the project goals within the given scope,...

Medical Monitoring

Participant safety is at the core of all clinical trials and one of the most crucial aspects of trial conduct. Safety monitoring during a trial is critical for evaluating and characterizing the associated risk of the drug and for making informed decisions on risk minimization. The purpose of safety monitoring...

Clinical Study Support

CDSA collaborates with Government Agencies and Institutions, Academic Institutions, and Small and Medium Enterprises (SMEs) in coordinating and/or implementing their clinical studies. A broad range of skills offered by CDSA include: regulatory consultation, project management, clinical monitoring, medical writing, safety monitoring, audit, data management and biostatistics support. Department of Clinical...

Clinical Monitoring

One core support provided by CDSA is in clinical monitoring. Clinical monitoring ensures that all systems followed during study conduct are as per international ethical and scientific quality standards which include but are not limited to ethics approvals, compliance with ethics approval terms, adherence to protocol, participant recruitment process, seeking...

Biostatistics

CDSA has the competence to provide bio-statistical support to various clinical projects from the planning stage right through the analysis and report or manuscript writing. CDSA has the required infrastructure in form of statistical analysis tool software and programs and a dedicated IT-infrastructure (data servers, systems, access-controls, etc.)  to run...

Regulatory Affairs

The Regulatory department supports Investigators and SMEs review pre-clinical and clinical trial protocols and other documents as per existing regulatory norms, support in Ethics Committee registration and in reporting of clinical research trials at CTRI. CDSA has the experience and proficiency to guide and advise on the regulatory pathway in...

Medical Writing

CDSA has been undertaking medical writing for regulatory clinical trials conducted in public health domain, ranging from dose-range finding studies to post marketing surveillance studies. We have provided support in protocol development; designing ‘Investigator Brochure’; developing informed consent documents (PIS and ICF), preparing risk/benefit assessment reports and clinical study reports...

Compliance Services

CDSA offers quality and compliance services. CDSA has conducted audits for various clients ranging from small start-ups, contract research organisations, biotechnology companies, and medical device & pharma companies. These services are also offered to bioanalytical and toxicology laboratories, ethics committee, investigators and clinical sites. CDSA has expertise and experience to...

News Room

Posted on:
May 31, 2019

National Workshop on Regulatory Compliance for Accelerating Innovations, May 29, 2019 @ NIPER, Hyderabad

CDSA along with DBT, BIRAC, CDSCO conducted its fourth among the six national workshops on regulatory compliance for accelera Read More
Posted on:
May 29, 2019

Interactive meet on New Drugs and Clinical Trials Rules 2019: Its understanding and impact

The “New Drugs and Clinical Trials Rules 2019” was released on March 19, 2019 by CDSCO, Ministry of Health & Family W Read More

Past events

Posted on:
May 29, 2019

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

The Department of Biotechnology (DBT) and Central Drugs Standard Control Organisation (CDSCO) along with Biotechnology Ind Read More
Posted on:
May 29, 2019

CDSA organizes GCP and GCLP programs at ICMR Headquarters

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

NCR Biotech Science Cluster
3rd Milestone, Faridabad – Gurgaon Expressway, PO box #04, Faridabad – 121001 (HARYANA)

0129-2876300