Trial Management Services

MOUNT SINAI SERVICES collaborates with its clients to design an efficient clinical trial process from protocol design to final outcome analysis - on time and on budget.  

Project Management

MSS provides each client with a dedicated project manager to ensure successful project completion, and offers strong, collaborative project management and access to designated technical staff to answer and respond to all client questions and needs.

Protocol Development

MSS can assist with protocol development in full accordance with ICH-GCP standards. We can work from the ground up to provide comprehensive protocols for Phase I-IV clinical trials, or provide consultative review and editing of draft protocols developed by trial sponsors or CROs.

Ethics Review and Approval

MSS can coordinate the preparation and submission of applications to local Institutional Review Boards to facilitate timely approvals for clinical trials. We have experience with local preferences for consent forms and other necessary documents and can customize templates for IRB requirements.

Site Evaluation and Setup

Our close relationships with clinicians and researchers allows MSS to efficiently identify and recruit respected investigators at academic centres and community clinics. Potential sites are reviewed and evaluated by our experienced staff to assess their capacity and qualifications for participation. MSS then manages relationships and requirements for selected sites, ensuring that all instructions are understood and carried out prior to study launch.

Data Management and Reporting

Our data management and reporting solutions are customized to each client and the specific requirements of their clinical trial.  Our Lab Information System (LIS) provides rapid and secure access to clinical trial data.  Automated data capture directly from testing equipment, and the use of bar-coding, ensure that error due to human interaction with client data is eliminated.