Navitas Life Sciences

Successful End-to-End Clinical Trial, Risk Management, Pharmacokinetic Monitoring Support and USFDA Audits for a Global Pharma’s Study on Renal Cell Carcinoma

A multinational pharmaceutical company headquartered in India and supplying pharmaceutical products to more than 100 countries, was interested in pursuing advancements in oncology research, and required expertise in conducting high-quality clinical trials for a study on renal cell carcinoma (RCC). They sought an end-to-end clinical trials partner to address the unique complexities of RCC studies while ensuring regulatory compliance.

Learn How Navitas Life Sciences Leveraged Its Expertise in Managing the Study During the COVID-19 Pandemic and beyond.

The project was initiated during the Initial stages of the COVID-19 pandemic, and it required expert support, fast movement to decentralized clinical study management with digital tools and rapid patient inclusion, overcoming COVID-19 mediated challenges and restrictions.

Fill the form and download the case study to find out how we:

  • Received Regulatory approval for the study received within 45 days.
  • Effectively monitored at site level, maintaining high quality standard and close coordination with Data Manager (DM), Medical, Lab team to move towards achieving database (DB) lock for study on time.
  • Ensured Successful completion of 2 FDA site audits without any 483 findings.

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