Trial Management & Site Monitoring
If independent management and monitoring of your trial is required, we will manage your clinical studies in collaboration with our sister company Context Clinical Research Inc.

Data Management
Our cost-effective data management services include double data entry, in-depth data validation, medical/science review of CRFs, coding of AEs and medications, integrating central laboratory data, periodic data exports, database lock, database audit and database release in SAS and/or in XML, as per CDISC specifications.

EDC
Our secure and 21 CFR Part 11-compliant edc system with its intuitive user interface is used to host your studies on-line. Key benefits include rapid deployment, flexible study configuration for all phases of trials, comprehensive on-line data validation, rapid change management, and experienced user support. Our system and services ensure analysis-ready data at any time.

Biostatistics & Medical Writing / Reporting
Our Biostatistics and Medical groups will be available to analyze your study results and produce industry standard clinical study reports (ICH report as per FDA's CTD), manuscripts, presentation materials, etc. - compliant with regulatory guidelines.

View our services in more detail.

View how our services comply with all regulatory guidelines.

We look forward to collaborating with you in the near future, please contact us.