Navitas Life Sciences

Integrated Clinical Data Services, Clinical Data Management, Biostatistics and Medical Writing 
Flexible Clinical Data Services Enables a Successful IND Submission

An international pharmaceutical Company headquartered in India, with limited infrastructure in Biometric services, was working on an investigational new drug (IND) which required complete Biometrics Service Support and medical writing support for the study with the sponsor conducting clinical operations. The study involved setting-up the database and providing full data management support including Biostatistics and CSR Writing services.


Navitas Life Sciences managed the challenging timelines and coordination with stakeholders in multiple time zones through effective project management, planning and communications.


This resulted in site improvements including CRF/ DCF Aging by Site report reduced from ~60%-70% to ~10-15% within 3 months of live DB. Overall discrepancy per patient was about 50% of the standard estimation and also the number of DCF was 4 times less than initial estimations.

 

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