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Simplify Study Start-up at Your Site: 5 Strategies for Streamlining the Contract and Budget Processes

Sites have only so much control over the budgeting and contracting process. At least half the responsibility lies with sponsors and CROs. However, with a little extra upfront preparation, sites can streamline negotiations, perhaps cutting weeks off the process and streamlining study start-up as a result. Here are five tips to help streamline the contract and budget process for faster study start-up at your site.

1. Visualize the Study Start-up Workflow

First begin by creating a flowchart and define what the study start-up process looks like for your institution. The study start-up process will look different for each site, but a basic flowchart may look something like this:

From there, drill down to the specifics.

  • Define the Process: Each site should outline its unique process flow, identifying key departments and approval stages. Get granular: Include the names of decision-makers and specify to whom issues should be elevated.
  • Identify Gaps: Once you lay all this out, you’ll be able to pinpoint areas of delay or conflict. Are there conflicting instructions? Does each step have an accountable party? Do some departments have slower response times than others?
  • Do a dry run: Test the workflow with hypothetical situations to uncover hidden bottlenecks. You may discover additional gaps or changes you need to make to your workflow.

By highlighting areas where processes might get stuck or become inefficient, a well-crafted visual flowchart can illuminate opportunities for improvement, even in the most organized sites.

2. Develop the Coverage Analysis Before the Budget

Developing the coverage analysis first helps smooth the process, reducing errors and misalignments. It becomes a roadmap for creating a detailed internal budget. By addressing all the cost issues in the coverage analysis, sites can prevent complications during the budgeting process.

Next, sites should build their internal budget. This version, visible only to the site team, forms the basis for reviewing and negotiating the sponsor’s budget template. It should include all the fees the site anticipates incurring, from per-patient fees based on the protocol’s schedule of events, to administrative fees, such as start-up, maintenance, close-out, and other conditional fees (such as monitoring and audit fees, chart review fees, serious adverse event report fees, etc.). 

3. Develop a Negotiator’s Playbook

The internal budget and the study start-up workflow provide the basis for a negotiator’s playbook. Create separate playbooks for budget and contract negotiators that include comprehensive information to expedite the negotiation process, clearly distinguishing between actual requirements and the “nice to haves”.

These playbooks should empower negotiators with detailed information and pre-approved alternative language options, reducing the need for constant escalation during negotiations. For that to happen, all the site stakeholders, especially the legal team, should weigh in on its development.

4. Finalize Everything Before the Informed Consent Form (ICF)

To avoid being forced to reopen negotiations, finalize the budget and the contract before the ICF. That’s the only way to ensure the ICF aligns with both.

5. Equip Negotiators with the Tools and Support They Need

It is critical to ensure negotiators understand which changes they have the power to accept and which changes need to be escalated. Much of that will be spelled out in the playbook, but some negotiators may need additional training.

If you equip your negotiators with what is and is not reasonable to accept, you will still come out with a win because you’ll receive a final budget much faster, which means enrollment can begin sooner.

By refining negotiation processes and equipping teams with the necessary tools and knowledge, research sites can accelerate study start-up times and make the contracting and budgeting process less onerous. The goal is not just to secure favorable terms, but to streamline the entire negotiation process for swifter study initiation and execution.

Looking for additional support for your site’s budget and contract negotiations? Contact us today to streamline your study start-up.

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