Expert Advice for Rapid Study Start-Up

Expert Advice for Rapid Study Start-Up

When working to operationalize clinical trial studies, the slower to launch, the more potential profit your company is losing. And although site identification is a key hurdle in getting studies off the ground, preparing a study is not a one-pronged approach. Take a minute to think about this analogy: Most people would be ecstatic to own a new luxury car, but what good is it without fuel to get it started?

Much like the car scenario, a successful study relies on a combination of site selection and rapid study start-up. Start-up delays impact overall delivery and results. As an experienced global project director, I have managed more than 1,000 investigational sites in more than 50 countries. Through that experience, I picked up a few tricks of the trade to ensure my clients meet all of their start-up timelines. Here are some practices to keep in mind:
 

  • Streamline your investigator search.
    Choose a vendor with a physician investigator database resource that offers a large pool for identification, regulatory knowledge of the countries of study, and targets the right size/sites for your needs.
     
  • Qualify sites with a rigorous evaluation process that includes specific selection criteria and thorough, confidential post-identification follow-up processes.
    Preparing up-front will greatly decrease chances of backtracking and/or duplicating efforts to meet requirement needs not initially specified.
     
  • Execute timely site contracts, regulatory submissions, and trainings.
    Use a proactive strategy – customize contracts based on protocol; a one-size-fits-all approach may not work, and is dependent on the product, site, and budgets.
     
  • Don’t delay protocol development.
    Ensure you have a team ready to start on the study protocol; as many downstream activities depend on their finalization.
     
  • Prioritize development of the data collection forms and edit specifications.
     
  • Create a flexible database development and validation plan.
    Helpful hints for designing these platforms can be found here and here.

The list above touches only on the high points of how to ensure rapid study start-up. If your trial would benefit from increased efficiency and the professional know-how of my expert team, please contact me.  I look forward to connecting to help ensure your product’s success.