Data Management
With more than two decades of experience providing customized data management services for clinical trials to our clients, SynteractHCR is a contract research organization that has developed a reputation for high quality, cost effective solutions to fit your unique project needs. We know the importance of accurate, timely data management for clinical trials, and that’s why we have implemented the right combination of technologies with the care and insight of experienced personnel. Our clinical data managers have medical and life science backgrounds and as well as specialized programming experience.
Excellent planning and organization allow us to meet aggressive timelines in all phases of clinical development with accuracy levels consistently above 99.9%. Both internal and external audits of our databases verify these near zero error rates – so you can be assured that your data is being managed properly. SynteractHCR has provided data management services for more than 1500 clinical studies with enrollment ranging from 3 – 140,000 subjects, including many global programs. Many projects have been rescued studies from other vendors, but none of ours have ever required it!
Our Clinical Data Management capabilities Include:
- Case report form (CRF) design, production and tracking
- Custom database generation
- CRF review
- Data entry with quality control
- Automatic edit checking and query tracking
- Data cleaning
- Electronic data transfers from 3rd parties (e.g. central lab, PK, ECG data)
- Superior quality control and assurance
- Rapid database closure
Clinical Data Management Methods Include:
- SynCapture® - Our proprietary, hybrid electronic data capture (EDC) system provides maximum flexibility and efficiency by allowing multiple modes of data entry including paper, fax and web based in the same study. The system makes data capture easy at a low cost with all data residing in the same database and undergoing the same edit checks.
- Marvin – This fully scalable, user friendly, FDA 21 CFR Part 11 compliant is from XClinical for p-CRF/ e-CRF studies (http://www.xclinical.com/). Marvin is a 100% CDISC ODM compliant EDC system that is highly user friendly. With MARVIN, we have captured the data of a total of 34,652 subjects at 127 sites in 18 countries. MARVIN integrates numerous functions from the areas of Electronic Data Capture, Double Data Entry, Clinical Data Management, Clinical Trial Management and electronic Patient Reported Outcome into one unique application with a centralized CDISC ODM database. The main benefit of MARVIN compared to other EDC products is the fact that MARVIN is built on the CDISC standard from the ground up and fully utilizes the advantages this offers throughout the Clinical Data Management process. MARVIN was one of the first two EDC software products to be officially certified for the ODM standard by the CDISC organization.
- Medidata Rave® - SynteractHCR is a Medidata Services Partner accredited in Medidata Rave, an industry leading system supporting both electronic data capture and clinical data management for clinical trials. It has the flexibility to support any organization’s clinical trial operations, cost-effectively. Medidata Rave also provides user-configurable eWork flows, sophisticated eCRF design, simple and complex edit checking, customizable security parameters and integrations of other data sources.
- Clinical DataFax™ - This fax-based technology supports data collection by fax, where CRFs are faxed directly from the sites to the clinical database at SynteractHCR, significantly reducing time to database lock. SynteractHCR has utilized DataFax since 1996 giving our database developers longstanding DataFax experience, allowing us to consistently create high-quality clinical database applications.
SynteractHCR can also provide data management support for a client’s preferred EDC system, having experience across multiple platforms including DataTrak 4.0, eTrials 2.5, InForm 5.0, InSpire, OC 4.5.2, TrialMaster and CT Engine.