Choosing the Right Clinical Research Organisation in India: Key Considerations and Benefits

Introduction

A Contract Research Organization (CRO) is a company contracted by manufacturers of pharmaceutical, biological or medical devices and in-vitro diagnostic kits to manage clinical research studies and other services to support product development in all phases of a clinical trial.

What is a CRO?

A contract research organisation (CRO) is a company contracted by another company or research facility to handle specific aspects of managing a clinical study. The business may plan, coordinate, and oversee the trial, as well as evaluate the outcomes. Pharmaceuticals can outsource part of their clinical trials to CROs in India.

Responsibilities of CRO

Fig 1: Responsibilities of CRO

Phases of Clinical Trial

Clinical research organisations in India play a major role in ensuring safe, ethical clinical trials that are essential to developing new, life-changing drugs and medical devices that benefit millions of patients worldwide. The 4 phases of a clinical trial include:

Clinical Trial Phase	Purpose
Phase 1	Tests new drugs in a small group to evaluate the safe dosage range and identify side effects
Phase 2	Tests the treatments safe in Phase 1 in a larger group. Larger group considered to check for any adverse Assess efficacy and further evaluate safety in a larger group.
Phase 3	Tests treatments in larger populations (different regions and ) To confirm the effectiveness, monitor side effects, and compare to existing treatments.
Phase 4	Conducted after a drug is approved by a Regulatory Authority Testing of treatments done in a wide population over a longer Post-market surveillance to monitor long-term effects and use in a wider population.

Table 1: The phases of a clinical trial

Considerations while choosing a clinical research organisation in India

The sponsor’s obligations under its guidelines for good clinical practice include:

Criteria	Responsibility
Quality Control and Quality Assurance	A sponsor may assign a CRO some or all of the sponsor’s trial-related responsibilities, but the sponsor is always ultimately in charge of ensuring the accuracy and integrity of the trial data. Quality assurance and quality control should be implemented by the CRO.
Documentation	Any trial-related responsibility or role that is delegated to or taken on by a CRO needs to be documented in writing. The sponsor is responsible for supervising all trial-related tasks performed on its behalf, including tasks that are subcontracted to a third party by the sponsor’s designated CRO(s).
CRO and Sponsor Capabilities	The sponsor retains all trial-related responsibilities and tasks that aren’t expressly delegated to or taken on by a CRO.
CRO and Sponsor Responsibilities	If a CRO has taken on a sponsor’s trial-related responsibilities, then all references to sponsors in this guideline also apply to CROs

Table 2: Considerations while choosing a clinical research organisation

What services do CROs in India provide?

Development of biological assays and biopharmaceuticals, product commercialization, pre-clinical and clinical research, clinical trial management, and pharmacovigilance are among the services offered by a CRO. A CRO is a blessing for both pharmaceutical and research needs, as they can multitask within a set timetable.

Fig 2: Services Provided by CRO

The services provided by CRO include:

Approval of Global Clinical Trials (GCT): A GCT approval is crucial for research and clinical studies. The flow of GCTs is as follows:
- Application for a GCT approval includes informed consent form, trial site details, investigator’s brochure, formulation data, preclinical data involving animal pharmacological and toxicological studies, results and clinical report of phase I, II, III trials, etc.
- A checklist of protocol development adjustments and modifications, both major and minor
- A copy of the letter granting authority to conduct clinical trials, the TR 6 challan, and other items are included in the import licence checklist.
- Verifying any site additions, deletions, closures, or changes to the lead investigator.
Safety reporting: A crucial facet of pharmacovigilance is safety reporting. Periodic safety update reports, or PSURs, are due once every six months for the first two years and then once every two years after that, as per schedule Y. PSURs cover the current status of worldwide marketing, updates on safety-related activities, etc.
Test licence: A test licence is essential to import small quantities of drugs, cosmetics, medical devices, etc. for research and development, testing, and analysis. Form 11 contains information on the application’s contents as well as a list of required attachments.
Clinical Trial Registry India (CTRI) Registration: ICMR’s National Institute of Medical Statistics handles the CTRI registration. It provides a free online public record registration mechanism for clinical trials conducted in India, as well as for multinational trials in which India is a participant country. Trial registration in the CTRI was once a voluntary procedure, but it is now a crucial and required step that must be taken. A registration number for every trial being undertaken in India must now be included in publications. The Indian target sample size, trial locations, enrollment date, and Indian investigator details are all included in CTRI. Following registration, it is required to update the trial status on a regular basis with any modifications.
Ethics Committee Registration: In order to receive ethics approval, an application for ethics committee registration must be submitted. To function in India, Ethics Committees overseeing clinical trials, bioavailability, bioequivalence studies, and biomedical research must register with the Central Licensing Authority (CLA). Application via Form CT 01 is required, along with specific details such as committee name, composition, office address, chairperson profile, member information, and standard operating procedures. CLA grants registration in Forms CT-02 or CT-03, valid for five years unless suspended or revoked.

Summary

Sponsors may choose to outsource all or part of the trial-related tasks to a company called a clinical research organisation or contract research organisation (CRO) to manage the clinical trial on their behalf
CROs are a fundamental part of clinical trials that offer a wide variety of services associated with conducting the study that facilitate the work of the Sponsor.
Choosing a good CRO is very important, as much of the success of the study will depend on its management and will help the trial run as smoothly as possible.

Conclusion

A CRO is a blessing for all pharmaceuticals, medical devices, and in-vitro diagnostic kits manufacturers. Research demands an ability to multitask within a set timeframe. Finding a trustworthy, qualified, and skilled CRO, however, requires effort and a thorough survey. CliniExperts decade-long experienced team is there to assist you. CliniExperts offers an organised, methodical, and cooperative approach to managing all regulatory matters. Our team of trustworthy industry professionals helps our clients find the ideal CRO in India for their requirements.

CliniExperts offers a single point of contact for all of your regulatory needs, from application to approval. In the event that there are any revisions or modifications, we offer post-task services to guarantee total client satisfaction well before deadlines.

References

Definition – Contract Research Organisation [Internet]. National Cancer Institute. 2011.
Available from: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/contract-research-organization
WHO. Clinical trials [Internet]. www.who.int. 2023. [cited 17 Nov 2023]
Available from: https://www.who.int/health-topics/clinical-trials#tab=tab_1
European Medicines Agency. Committee for Human Medicinal Products Guideline for good clinical practice E6(R2) Step 5 [Internet]. 2016.
Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-good-clinical-practice-e6r2-step-5_en.pdf
CRO Support, Clinical Trials, Research & Approval – CliniExperts [Internet]. cliniexperts.com. Available from: https://cliniexperts.com/india-regulatory-services/cro/
New Drugs and Clinical Trial Rules, 2019, Ministry of Health and Family Welfare, Notification, G.S.R. 227(E). March 19, 2019. Available from: https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/NewDrugs_CTRules_2019.pdf

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Choosing the Right Clinical Research Organisation in India: Key Considerations and Benefits

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