For Physicians
Committed to the improvement of patient outcomes and advancement of medical science through innovation and quality execution of clinical research.
Growing Research Together
By working with SCRI, practicing physicians can add clinical research to their practice with minimal disruption to office workflow. SCRI allows access to the latest in medical breakthroughs while diversifying sourcesof financial revenues.SCRI, an industry leader in clinical trials, is dedicated to advancing solutionsfor patient care through clinical research. SCRI conducts the largest, community-based research program in the nation, including clinical trials in 10 therapeutic areas through its affiliation with a powerful network of hundreds of physicians. Additionally, SCRI offers management, regulatory and other research support services to drug development sponsors and strategic investigator sites across the country.Physician practices often lack the capital and infrastructure to manage clinical trials on their own. SCRI works with existing groups, forming a network of skilled researchers and then supplying the technical infrastructure and standardization support needed to effectively manage clinical trials in a community setting.
Program Development
- Interacting with numerous pharmaceutical companies and contractresearch organizations to develop a deep and broad trial menu.
- Reviewing the feasibility of each trial under consideration through theweekly Protocol Review Panel, a multi-disciplinary panel consisting of amedical director and representatives from Study Recruitment, FinancialServices, Clinical Services, Quality Assurance, Data Management andPatient Recruitment.
- Accessing multiple sites through one central organization.
- Simplifying communication by serving as the point of contact for trackingand completion of confidentiality agreements and pre-study questionnaires.
Patient Recruitment and Advertising
- For applicable studies, coordinating all advertising and patientrecruitment activities.
- Producing all advertising campaigns for optimal patient response includingmedia selection and advertisement development
- Pre-screening and pre-qualifying all responses to advertising and onlypresent qualified patients.
Contracting and Financial Services
- Simplifying financial aspects by negotiating the budget reimbursementfor all studies.
- Managing all financial study obligations such as patient stipends,purchased services and contractor payments.
- Tracking the progress of the trial and invoicing sponsors for paymentin a timely manner.
- Reconciling of amounts due and monies received on a monthly basis.
- Reviewing and negotiating all contracts to include appropriate paymentterms and indemnification provisions.
Clinical Services
- Assisting with interviews, selection and hiring of research coordinators.
- Providing in-depth training for new coordinators. Local training updatesoccur frequently.
- Offering daily oversight, support and guidance to physicians and coordinators.
- Assuring that smooth and timely communications occur between the site,the coordinator and the sponsor.
- Providing local site support via a Site Manager.
- Providing oversight and support to enhance patient accrual.
Regulatory Submissions
- Preparing initial regulatory packets and study documents with site-specificinformation for sponsor and Institutional Review Board (IRB) approval.
- Preparing and submitting required ongoing regulatory documents to thesponsor and IRB.
- Minimizing rapid turnaround times for the preparation and deliveryof regulatory packages.
Quality Assurance
- Preparing comprehensive internal audit reports for any selected organizationalong with a plan for corrective action.
- Providing oversight and a quarterly internal audit to assure compliance withall study-related activities.
- Reviewing all processes for compliance with GCP (Good Clinical Practices),ICH and FDA guidelines.
- Reviewing site research documentation and providing guidance in preparationfor external sponsor and FDA audits.
Digg
Del.icio.us
Yahoo
Google
Newsvine