CRO SERVICES
Data Sciences: Data Management & Statistics
SRA gives clients a fast, accurate read on studies in progress with transparent data management and statistical analysis services. We provide customized statistical consultancy support in all areas of drug development. Our international reach and large talent pool enable us to quickly establish global support for a diverse client base, including start-ups, venture capital-backed biotechs, medical device firms and pharmaceutical companies.
Working within a flexible framework of our own ICH-compliant procedures or those of our clients, we use industry-standard tools, like Oracle Clinical™, Oracle Clinical RDC™ and SAS®, to deliver high quality results. Our seasoned data sciences experts have passed external systems audits and a voluntary MHRA audit.
Assisting with Phase I-IV studies around the world and across a wide range of therapeutic areas, they are skilled at dealing with national regulatory bodies like the FDA, EMEA, MHRA, and BfArM.
Benefits
- Ensures strategic approach to data collection and analysis
- Improves data accuracy
- Provides local support around the globe
- Speeds time to market
Services
- Study design, sample sizing and protocol writing/review
- Randomization
- CRF and database design
- Data entry
- Data management, including data tracking, validation checks and quality control
- Managing and reconciling laboratory and other external data
- Medical dictionary coding
- Electronic Data Capture
- Table, figure and listing production for study reports
- SAS programming
- Pharmacokinetic/Pharmacodynamic modeling
- Statistical consultancy
- Regulatory submission support, including ISS and ISE data integration and analysis
- DSMB statistical support
- Project management