Translational Health Science and Technology Institute
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The Clinical Development Services Agency has the core strength and capability to support a trial or study from its set-up to archiving.
The various verticals within CDSA work in collaboration with the investigators and the sponsor to ensure the delivery of a robust and quality-driven trial.
The Clinical Portfolio Management team has in the past conducted the data and process monitoring for large, multicentric trails and studies. The monitoring plans and strategies are developed in consultation with the sponsor and Principal Investigators, in compliance with the applicable guidelines. An overview of the services offered:
The CPM team ensures data quality by implementing various monitoring strategies, depending on the study. The team can carry out the source data verification of the case report forms, review the informed consent forms for completeness and accuracy, and ensure that the team members at participating sites do not make recurrent mistakes in data capture and/ or entry.
The assigned team will also ensure that the staff members at the participating sites adhere to the protocol and applicable guidelines, through process monitoring. For instance, review of the consenting process, clinical data collection, etc.
The CDSA team can assist with the safety monitoring aspect of trials by assisting the principal investigator and site investigators with adverse event(s) and serious adverse event(s) reporting, and ensuring that the applicable timelines are followed.
Depending on the project, the CDSA team can hep set-up and conduct the trial, while ensuring that the quality of data is maintained. The team assists with:
The team at CDSA can assist with the development of Statistical Analysis Plan, data validation, programming, sample size estimation, exploratory data analysis and data visualization.
Research Methodology is the most important dimension of any research. It enables the researchers to develop the most appropriate methodology for their research studies. The mission of this training program is to impart research method skills to the researchers/beginners and help improve the quality of research. The learning of research methodology can move from rote learning to a fun-practical method; from a teaching process to an experimental process, from memorizing to brainstorming, from clearing the examination to flip learning, from knowledge transfer to knowledge creation, from competitive learning to collaborative learning.
CDSA had launched two online courses on the SWAYAM portal (https://swayam.gov.in). This is a free online education portal supported by the Ministry of HRD, GOI. These online courses were designed and developed by CDSA’s training team, reviewed and recorded by CDSCO and CDSA. The course was developed in collaboration with NPTEL/IIT Madras. The courses areinteractive, with a discussion forum, weekly assignments, LIVE sessions with faculty, proctored (optional) exam, etc. Based on a sound and systematic approach, these courses offer a platform to learn from the best, virtually.
Bioethics training program provides research ethics education to all members of the research community, especially those engaged in health research and clinical research/trials. This program aims to build capacity for the ethical review of health research and to strengthen the capacity of the Ethics Committees in institutions. Furthermore, this program aims to produce bioethics experts who can contribute to the global bioethics discourse
This course is designed for all clinical research professionals to understand the key principles of GCP, including but not limited to informed consent, ethics committees, the key roles (sponsor, monitor, investigator, and institution), documentation, records management, investigational medicinal product management, safety reporting, and quality assurance.
Good Clinical Laboratory Practice training program is for all those desirous to gain an in-depth understanding of GCLP and how each principle of GCLP can be applied in the clinical trial laboratory. This training program describes the standards to be followed by laboratories that perform analysis or evaluation of clinical trial samples. The program covers all aspects of GCLP from the setup and planning of the analytical lab (based on the type and quantity of samples to be processed), right through to the documentation and analysis.
CDSA webinars series offers a unique opportunity to engage with subject experts in the area of clinical development and research. These complimentary webinars are open to all public and arespecifically designed for clinical research professionals.
The Clinical Trials Toolkit has been designed by CDSA to provide guidance to researchers who are interested in conducting clinical trials in India. The purpose of the toolkit is to serve as an interactive roadmap and provide guidance and information on the various steps a researcher will need to keep in mind while planning a clinical trial in India.The toolkit provides guidance on both academic and regulatory clinical trials. However, many of the steps are applicable to all types of research studies.
e-EC is an online platform that facilitates submission of ethics related applications (by researchers) and their subsequent review by the Institutional Ethics Committee. It has been designed in accordance with the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants 2017,New Drugs and Clinical Trial Rules 2019 and the FERCI Standard Operating Procedures for Ethics Committees.
The GCPPCS is a first of its kind certification based on the International Personnel Certification Standard (ISO 17024:2012). It aims to achieve a uniform competence standard, using internationally accepted best practice for assessment and certification. It has two aspects – a system of accreditation of Training Institutions to ensure standardised, high-quality GCP training and certification (by Third-Party Certification) to promote certification of GCP professionals both within the country and across the globe.
The Data Science vertical plays an important role in the development of various data management systems and support for the studies undertaken at CDSA. This vertical promotes best practices in several areas including database development, adherence to regulatory requirements, standardization and simplification, data management methods, quality control and assurance.
CDSA uses different databases, approaches depending on the needs of the study. CDSA has procured validated and regulatory compliant commercial Clinical Data Management Systems (CDMS) including ODK which is useful in capturing the offline data through phones and tablets. Based upon study requirements CDSA also provides data management using open sources like REDCap and OpenClinica. The Data Science group also supports study websites and develops systems to support unit processes. The DM standards and procedures are tailored to ensure an optimal utilization of CDMS and monitoring tools. The group also provides support to study teams and database programmers for the development, deployment and maintenance of study databases.
At CDSA, the following systems are used to provide data management, project management and monitoring support to the studies:
One of the core strengths of CDSA for supporting the clinical studies is Clinical Data Management (CDM). CDSA is currently providing data management support to many multi-centric clinical studies & clinical trials from CRF designing to database development and database lock & archival.