Services | Theorem Clinical Research - study initiation services

By: Theorem Clinical  09-12-2011
Keywords: health care, Project Management, clinical research

Study Initiation—And Throughout the Life of Your Study.

Theorem Clinical Research understands the importance of accelerating the site activation process -- and we're structured to streamline these activities. Our experienced professionals form project specific study initiation teams to carry out investigator recruitment through site activation and are the primary site contact through this phase of your study.

Your Study Initiation Manager is your greatest asset to rapid study start-up. One leader provides focused oversight of the study initiation team and proactively works with you and our Project Lead to achieve the site activation goals.

  • Feasibility. Our dedicated, global feasibility team performs protocol, country and enrolment assessments in all major therapeutic areas, globally, and works closely with our therapeutic experts in both our medical and project management groups for value-added input. Items for exploration can include comments on study design and anticipated protocol challenges, the presence of competing studies, investigator grant estimates, the types of facilities utilized, and enrolment estimates.
    Please see your Theorem Clinical Research representative for more information on feasibility pricing.
  • Investigator Recruitment. Our investigator recruitment plan is tailored to your particular study. We utilize our properietary investigator database, along with commercial databases, relevant health care organizations and your recommendations, to choose sites for consideration. The Study Initiation Manager ensures the right questions are asked and evaluated throughout the screnning and recruitment process to select sites for a qualification visit.
  • Site Activation. The study initiation team evaluates each site's IRB and agreements process to project site-specific activation dates. The team coordinates the collection, review and tracking of essential documents and assists the sites to achieve their activation dates.
  • Clinical Trial Applications. Our local country experts understand local country guidelines and provide central management and coordination of Clinical Trial Applications (CTAs). These experts, coordinated by the Study Initiation Manager, provide counsel on CTA requirements and timelines, assist in the selection of appropriate countries for the project, coordinate submissions to regulatory authorities and ethics committees, as well as assist with responses to questions from the regulatory authorities.

Keywords: clinical research, Clinical Trial, health care, Project Management, Provide Counsel, Recruitment Plan, Recruitment Process, Research Representative, Study Design,

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