Depth, Experience & Flexibility – The Keys to Seamless Continuity
In every clinical research program, sponsors must bring together targeted expertise to address unique needs and challenges. CRO service providers must adapt service models to both broad and narrowly focused needs. PROMETRIKA has the depth, experience and flexibility to work with sponsors as a Functional Service Provider (FSP) in specific areas of expertise, including stand-alone clinical monitoring, data management, biostatistics, programming, medical writing and regulatory services.
Our nimble, collaborative culture allows us to support seamless continuity of operations. We can work with sponsor SOPs and workflow or we can use ours. We leverage our technical skills and IT infrastructure to facilitate working in the sponsor’s or PROMETRIKA’s computer systems.
PROMETRIKA also delivers highly streamlined and tailored services for very specific needs at any stage in a clinical research program, including:
- Stand-alone database build and User Acceptance Testing (UAT)
- Comprehensive support of Independent Data Monitoring Committees (IDMC), independent adjudication committees, clinical event committees
- Independent validation of SAS® programs
- Stability analyses for drug expiration dating
- Statistical validation of centralized randomization via IWRS