Clinical Project Management
Key to the success of a full-service project is the Project Manager. The project manager will break down the project goals and scope into deliverable components, compile a project plan and associated documentation and oversee the work of the project team to ensure the timely delivery of project-specific milestones. The project manager will be the main contact for our client and will provide routine project updates on study progress.
It is our experience that a strong scientific background with passion for detail orientation and critical reviewing are mandatory skills in order to deliver a world class proof-of-concept study. Thus, for such early clinical stage projects, we recruit the Project Manager from our pool of Clinical Research Scientists. Other skillsets are more relevant for managing classical ‘large-scale, big pharma, phase 3 trials’, e.g. the ability to obtain results through management of larger group of people and systems, whereas the scientific background is of lesser importance.
Project management activities are divided into three phases, start-up, maintenance and closeout. The specific activities undertaken during each phase will change in emphasis as the project develops. All project management activities will be conducted in accordance with the SMERUD SYSTEM as detailed in a dedicated SOP . The PM is responsible for the coordination and management of all activities to ensure delivery of the project in accordance with the specifications agreed with the client.
ICH-GCP quality standards
Strict compliance with ICH-GCP is key to our operations. Our QMS is fully compliant with ICH-GCP R2. A complete set of SOPs is available to cover all aspects of ICH-GCP. Our staff receives a full GCP refresher training every two years and is trained on the GCP compliant SOPs to ensure that all our work is conducted in accordance with GCP. Further, our clinical research associates (CRAs) ensure that site staff are properly trained on GCP and that the site activities are GCP compliant. Work performed by the site (incl. GCP compliance) is continuously monitored by the CRA. Work performed by SMERUD project staff (incl. GCP compliance) is supervised by a SMERUD project manager. In addition to the hands-on, project specific follow-up, compliance is monitored by internal audits.
Feasibility analysis
A feasibility survey is performed to identify and select potential investigators/sites for participation in the study. As part of this process, the SMERUD collective corporate experience is reviewed with regard to similar clinical trials conducted before, and our experience with participating investigators and sites. In addition, we perform literature review and structured searches in clinical trial databases to identify investigators active in the relevant therapeutic area. From these activities a comprehensive list of potential investigator sites is developed.
A study-specific feasibility survey form is then developed for submission to the potential investigators. A list of criteria for rating potential site performance such as ability to enroll target population, adequately trained staff, access to specialized equipment, involvement in other clinical studies etc. is developed. Following receipt of the responses to the feasibility survey from potential investigators, an analysis is performed resulting in a feasibility study report, encompassing a priority list of investigators for review with our client.
Pre-study visits (site selection visits) may be a part of the feasibility study, and/or be conducted following a short-listing of potential investigators.