Project:
An Indian start-up developed its first in vitro diagnostic (IVD) semen detection kit and needed validation of its sensitivity, specificity, and diagnostic accuracy to gain CDSCO approval. Additionally, they sought to ensure compliance with European standards for future market expansion.
Solutions:
- Study Design:
- D2R Global Consulting drafted a complete clinical protocol and other associated documents required for the study, including detailed biostatistical analysis, to meet CDSCO guidelines and align with European regulatory standards.
- Ethics and Registration:
- D2R obtained Institutional Ethics Committee (IEC) approval and registered the study with CTRI, ensuring full compliance with regulatory and ethical standards.
- In-House Execution and Submission:
- D2R conducted the entire project in-house, including 280 healthy individuals recruitment, data collection & analysis, and documentation, all within four months. This enabled the client to submit for CDSCO approval in record time and at a highly competitive cost.
Outcome:
The semen detection kit successfully demonstrated the required sensitivity and specificity, securing CDSCO approval. The start-up is now prepared for the product launch in the Indian market and well-positioned for future expansion into the European market.
