Functional Service Provider
In every clinical research program, sponsors must bring together targeted expertise to address many unique needs and challenges. CRO service providers must have the range of experience and the flexibility necessary to adapt service models to be able to address both broad and narrowly focused needs with customized precision.
As a functional service provider (FSP), PROMETRIKA often delivers highly streamlined and tailored services to address very specific needs at any stage in a clinical research program. While the goal in these efforts is targeted support delivered with optimal precision and efficiency, the PROMETRIKA team also has the depth of experience and perspective that allows us to incorporate the essential levels of broader understanding necessary to customize functional service to deliver maximum benefit. To support seamless continuity of operations, we also have the technical skill and IT connectivity in place to operate under a sponsor's systems and SOPs or to facilitate customized and integrated access to our own proprietary systems.
PROMETRIKA experience in delivery of targeted functional service includes:
- Independent validation of SAS programs
- CDISC SDTM conversion programming to generate submission ready datasets accompanied by the required documentation
- Comprehensive services in support of independent data monitoring committees/ independent adjudication committees/ clinical event committees
- Independent validation of SAS® programs
- Phase 1 data management
- Phase 1 statistics
- Adaptive design trials
- PK/PD analyses, including PK parameter calculations
- Meta analyses
- Stability analyses for drug expiration dating
- Design and analysis of pharmacoeconomic studies
- Medical Writing and editorial services related to all needs including abstracts, posters, manuscripts, and scientific meeting presentations
- Statistical validation of centralized randomization via IVRS
- Randomization Call Center services