Clinical Trials Systems (IVRS, EDC and CTMS)

Clinical trials sponsors depend on clinical application technologies like IVRS, EDC, and CTMS to manage important aspects of human clinical trials of investigational drug products and devices. These systems are used mainly for patient enrollment and randomization, clinical supplies management, and patient data collection and cleaning. Clinical researchers today do not have a comprehensive information technology system to conduct and manage their clinical trials, and generally need to combine the use of multiple systems and vendors to meet their needs. This adds a layer of complexity that we can help clients understand and manage.

Our core team of principals and consultants has extensive experience with IVRS, EDC, and CTMS initiatives and projects. We provide services to both clinical trials sponsors and the application service providers and vendors. We can play a key role on these team including providing project management, analysis, development, and validation services.

For clinical trials sponsors, we support clients with their needs assessment and vendor selection of either the contracting to an application service provider or the technology transfer of a vendor’s solution to their internal IT environment. We support the programming and validation of IVRS and EDC study applications with highly skilled resources.

For application service providers and vendors, we provide contract staffing to support development and validation operations, as well as assist with strategic technology projects for new product development and upgrades.