Study Management

Syreon provides professional Study and Project Management Services to ensure that trials are conducted in accordance with the most stringent scientific and operational objectives. Options for Senior Tier Study Management models, customized to the requirements of each Sponsor and study, are shown in the following sections.

Executive Committee

This committee comprises key representatives from the sponsor and from Syreon, and is designed to ensure clear communication and efficient study operation. Executive Committee teleconferences are held regularly to discuss study progress and related issues, and are facilitated via a special access application on the study web site documenting study performance, milestones, minutes, reports, payments and other key measures.

Scientific Advisory Committee

This committee consists of key opinion leaders from the relevant discipline, who may or may not be investigators in the study. This Committee convenes at least quarterly in person or by audio-visual conferencing. The Scientific Advisory Committee provides expert advice on all relevant aspects of the program, including the study protocol and analytical plan, selection of participating centres, choice and use of outcome measures, review of the analysis plan, and preparation, submission and authorship of all scientific communications, presentations and publications.

Data or Safety Review Committee

This committee normally consists of medical and statistical experts in the relevant field, who generally are not investigators in the study. The Data Safety Monitoring Board normally meets in person or by audio-visual conferencing at least quarterly, or as otherwise determined by study needs. The Data Safety Monitoring Board is responsible for review of all data reports, interim analyses, and recommendation regarding premature study discontinuation based on success, toxicity or futility.

Project Management

Project Management services at Syreon are designed to ensure that all studies are conducted on time, within budget, and in accordance with ICH GCP and all other relevant regulatory guidelines (including privacy legislation such as HIPAA in the USA, PIPEDA in Canada and applicable regulations in the European Union).

Highly trained professional project managers work closely with each sponsor to identify the precise study objectives, timelines and critical outcomes; to support the Executive, Scientific and Data Review Committees; to co-ordinate the internal project team; to track communications, timelines, milestones and operations throughout the study; and to ensure timely and accurate completion of study reports.

Project management procedures follow a structured and efficient sequence from concept to completion, preparing from the start for successful database lock, analysis and reporting. Detailed project plans guide the operation of all studies, and progress reports ensure that all issues impacting trial progress are clearly understood, documented and resolved from initiation through to data export and the provision of the final report.