Contract Research Organization CRO Clinical Data Management Biostatistics Scian

Overview of Services: Medical Devices Companies

SciAn Services has extensive experience in supporting the clinical development and registration trials of medical devices. We can assist you with protocol development, data management, biostatistics and reporting in your path to obtain regulatory approval by FDA and Health Canada. Utilizing our effective project management and data management systems, we are able to offer a wide-range of cost-effective solutions.

Trial Management & Site Monitoring
We will manage your clinical studies in collaboration with our sister company Context Clinical Research Inc. and your in-house staff or other CROs, as required.

EDC
Our 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.

Traditional Data Management Services: double data entry, data validation, coding, medical/science review, central lab data transfers, DSMB support, on-demand/scheduled data exports/lock; database audits.

Biostatistics & Medical Writing / Reporting
Our Biostatistics and Medical groups will be available to analyze your study results and produce industry standard clinical study reports ready for regulatory submission, 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.