We spend time, pass the time and we certainly can’t stop its march. When it comes to the conduct of clinical trials, time is of the essence. reports that for clinical research associates, “The typical work week is 60 hours…”. How can clinical research site professionals maximize their bandwidth and increase the time they have to provide excellent care to patients? One approach is to engage the expertise of clinical trial services specialists who can effectively and intelligently negotiate budgets and contracts with sponsors/CROs.

Research sites encounter two major structural disadvantages when negotiating study budgets with sponsors. Firstly, negotiating study budgets requires an interesting mix of talents: negotiators need the business savvy of executives with the regulatory insights of attorneys. Secondly, negotiations require extensive planning and tracking. Often, research site staff are just too busy to fully optimize their negotiating strategies. Patient care, data collection and regulatory compliance are the forefront at the site level.

Instead of tasking one research staff member, generally the PI (Physician Investigator) with shepherding the contract process and serving as the singe point of contact for all parties, hiring a third-party fiscal agent streamlines this necessary, complicated and time sensitive process. The most skilled financial teams review budgets and contracts in meticulous detail, line by line, to negotiate transparently. The universe of items to be negotiated, according to PDF includes:

  • Regulatory compliance
  • Confidentiality
  • Publication
  • Intellectual property and study data
  • Indemnification
  • Subject injury
  • Insurance
  • Payment
  • Third-party reimbursement
  • Termination rights
  • Limitations of liability
  • Independent contractors

It’s essential to take a granular approach and thoroughly analyze the protocol to account for all possible overhead. Innovative management of pass-through fees further augments clinical trial budgets. The time savings for research site staff means that there is much more time to devote to research and most importantly, patients.

There is a significant benefit for patients when the CRC (clinical research coordinator) has the opportunity to forge a trusted, professional relationship. When patients feel comfortable and supported, they are also empowered to ask questions, communicate any apprehensions they may have, and provide key insights into their experience with the given study. In this environment, the CRC can more easily assist patients navigating the study process. Study compliance, adherence and retention rates are magnified.

It is challenging for CRCs to balance time for patients with administrative duties. Outsourcing budget and contract negotiations enables CRCs to truly focus on excellence in patient care.

GuideStar’s research finance team has years of experience with clinical research budgeting and billing, and regularly performs budget and contract negotiations for hospitals, health systems and physician practices around the country. Our service delivery is based on operational and financial best practices to ensure optimal results for research programs.

GuideStar Staff

Post by GuideStar Staff

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