IMR

  Program Benefits for Physicians

By working with Insight Medical Research, physicians can add clinical research to their practice with minimal disruption to office workflow. Insight Medical Research allows access to the latest in medical breakthroughs while diversifying sources of financial revenues. Insight Medical Research (IMR) is an industry leader in clinical trials, is dedicated to advancing solutions for patient care through clinical research.

Physician practices often lack the capital and infrastructure to manage clinical trials on their own. IMR works with existing groups to form a network of skilled researchers and supply the technical infrastructure and standardization support needed to effectively manage clinical trials.

Program Development

  • Interacts with numerous pharmaceutical companies and contract research organizations to develop a deep and broad trial path.
  • Reviews the feasibility of each trial under consideration through Protocol Review, Financial Services, Clinical Services, Quality Assurance, Data Management and Patient Recruitment.
  • Accesses multiple sites through one central organization.
  • Simplifies communication by serving as the point of contact for study start up from completion of CDAs and feasibility questionnaires to site activation.

Patient Recruitment

  • For applicable studies, coordinates all advertising and patient recruitment activities.
  • Pre-screens and pre-qualifies all potentially qualified patients.

Contracting and Financial Services

  • Simplifies financial aspects by negotiating the budget reimbursement for all studies.
  • Manages all financial study obligations such as patient stipends, purchased services and contractor payments.
  • Tracks the progress of the trial and invoicing sponsors for payment in a timely manner.
  • Reconciles of amounts due and payments received on a regular basis.
  • Reviews and negotiates all contracts to include appropriate payment terms and indemnification provisions.

Clinical Services

  • Assists with selection and hiring of research coordinators.
  • Provides in-depth training for new coordinators. Local training updates occur frequently.
  • Offers daily oversight, support and guidance to physicians and coordinators.
  • Assures that smooth and timely communications occur between the site, the coordinator and the sponsor.
  • Provides local site support.
  • Provides oversight and support to enhance patient accrual.

Regulatory Submissions

  • Prepares initial regulatory packets and study documents with site-specific information for sponsor and Institutional Review Board (IRB) approval.
  • Prepares and submits required ongoing regulatory documents to the sponsor and IRB.
  • Minimizes rapid turnaround times for the preparation and delivery of regulatory packages.

Quality Assurance

  • Prepares comprehensive internal audit reports for any selected organization along with a plan for corrective action.
  • Provides oversight and a quarterly internal audit to assure compliance with all study-related activities.
  • Reviews all processes for compliance with GCP (Good Clinical Practices),ICH and FDA guidelines.
  • Reviews site research documentation and provides guidance in preparation for external sponsor and FDA audits.