An effective monitoring strategy considers factors including the medical condition concerned, the class and nature of the device, the phase of development and the complexity of the clinical investigation. Our expert team will develop an appropriate strategy, combining close support for the sites and remote activities with on-site visits as required. ClinChoice supports a risk-based approach to monitoring, ensuring efficiency and adherence to regulatory expectations.
Medical Devices & Diagnostics
Rigorously Monitor Clinical Activities at Every Stage
As the crucial interface between project teams and Investigators, our CRAs demonstrate top clinical monitoring skills to address site-level issues proactively. With rich experience and a robust training program, including modules on ISO14155, as well as technology powered by Techorizon, a wholly owned subsidiary of ClinChoice, our CRA team monitors all project parameters for compliance with the clinical investigation plan and regulatory requirements. Supported by an internal data visualization platform, ClinChoice also implements risk-based monitoring according to industry standards to ensure monitoring activities are focused appropriately on sites or data requiring the most attention.
Robust Training System
ClinChoice prioritizes training to equip every CRA with additional and up-to-date regulatory knowledge and technical prowess. All individuals undertake a personalized training program to ensure they’re well-prepared to provide high-quality services that consistently earn trust and recognition from our partners. This means you can always rely on the quality of the ClinChoice CRAs assigned to your clinical investigation.
Flexible Delivery Models
Our CRAs are home-based and strategically located to enhance local language and cultural comprehension while also minimizing travel and inefficiencies. We’ll leverage a delivery model that suits your operational needs, ensuring quality in medical devices and diagnostic clinical development. In addition to our full-service offering, we provide CRA teams on a per-project or Functional Service Provider (FSP) basis.