A late CDSCO regulatory mandate required 50% of the study population to be enrolled through an ICMR-recognized government Phase I site. With more than 75% of recruitment already completed and clinical trial material expiring within one month, the sponsor needed to urgently activate a qualified site and complete the remaining enrollment.
InoRx leveraged the SRM clinical research network to rapidly activate an ICMR-recognized Phase I site. The team conducted on-site knowledge transfer from the previous CRO, accelerated Ethics Committee approval, trained the clinical team, and pre-screened potential participants in parallel with the regulatory review to enable immediate enrollment following site initiation.
The site was activated and EC approval achieved within approximately two weeks, with 75 potential participants pre-screened during the review period. The regulatory requirement was fulfilled, enrollment was fast-tracked, and the study remained on schedule despite the late mandate. The sponsor audit was cleared, and the successful execution resulted in strong customer satisfaction and repeat business.
A Case Study in Accelerated Site Activation and Enrollment
A Phase I healthy-volunteer study assessing a rheumatoid arthritis molecule encountered a late regulatory mandate.
The previous CRO had already completed more than 75% of recruitment when the Central Drugs Standard Control Organization (CDSCO) required 50% of the study population to come from an Indian Council of Medical Research (ICMR)-recognized government Phase I site. The sponsor therefore needed to urgently onboard a qualified site and complete the remaining recruitment.
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