ClinicalRM Clinical Technology
Clinical Trial Management System
ClinicalRM uses OnPoint, a web-based clinical trial management system which provides clinical trial support from study beginning to end. The system enforces role-based access controls and business rules for data entry at a system level and a study level, which ensures data security and consistency. Information regarding a product, program, or a study can be collected and reported through prebuilt reports and dashboards, with custom reports possible through integrated Microsoft Office support. ClinicalRM uses OnPoint for site identification and management, milestone tracking (at a Study, Region or Site level), CRF tracking, subject management, document management, payment tracking and invoice creation. To aid in clinical monitoring, the system can generate study-site specific monitoring reports with data prepopulated from within the database (such as Action Items from previous visits). Data entered on these reports can be automatically imported back into the OnPoint system once they are approved, and be signed using a 21 CFR part 11 compliant eSignature. OnPoint can also integrate with other programs, such as an EDC, if necessary. Information from OnPoint is made available to study sponsors via a secure Sharepoint site in the form of study reports and essential documents.
Remote Data Capture (RDC)
ClinicalRM offers Oracle RDC as a data management system for clinical trials. Oracle RDC is a robust system offering sponsors flexible study support capability. Oracle RDC is efficient and scalable providing the ClinicalRM Data Management Team with a platform which meets sponsor needs while streamlining study startup. Study set up in Oracle RDC provides a study ready case book which can be used to generate paper case report forms as needed. The RDC user interface has been designed to improve the efficiency and accuracy of case report form completion thus decreasing data discrepancies.