News | April 8, 2014

Rho Shares Lessons Learned In Rescuing Clinical Trials

Source: Rho
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Rescue trial experts discuss red flags, tips for selecting an effective CRO

As a first-class provider of clinical trial rescue services, Triangle-based contract research organization (CRO), Rho, is often called upon to resolve issues when clinical research studies do not go as planned. Drawing on valuable experience working on dozens of federal and commercial rescue studies, Rho clinical data scientist’s Alicia McNeil and Elizabeth Kelchner provide sponsors with the following lessons learned in sponsor-CRO partnerships, including the red flags for when a sponsor should consider exploring a new CRO, tips for selecting a new one and how to make a transition between CROs go as smoothly as possible.

Recognizing You Need a New CRO

  • You loved the experienced team you met at the initial meeting, but upon project award you were assigned a different, less-experienced team (the bait and switch).
  • Project team members don’t return your calls or answer your emails in a timely fashion.
  • You don’t have regular access to status reports.
  • You haven’t seen important study documents like a project management plan or data management plan.
  • There are signs data isn’t being collected or managed properly
    • Your CRO is collecting data in a system that was not designed for clinical trial data (like Excel).
    • Queries aren’t being sent or closed on a regular basis.
    • You aren’t given the opportunity to perform User Acceptance Testing (UAT) in the Electronic Data Capture (EDC) system.

Selecting a New CRO to Rescue the Trial

  • Ensure that the potential new CRO has a thoroughly documented rescue process or rescue project plan template.
  • Ensure that the CRO has successfully implemented rescues between the applicable platforms (EDC to EDC, Paper to EDC, EDC to Paper).
  • Be sure the CRO understands the need to minimize and manage process change for clinical sites.

Transitioning Effectively to a New CRO

  • Keep copies of all documentation, including Data Management Plans, annotated case report form (CRF), build specifications, decision logs, etc., in case you need to transition to another CRO. Don’t rely on the incumbent CRO to do this—the more historical information available to the new CRO, the better.
  • Obtain regular data transfers.
  • Request and implement a communication plan. Know how to escalate issues if needed.
  • Have regular meetings with all team members to ensure that everyone is on the same page.
  • Try not to burn bridges too early with the CRO from which you are transitioning.
  • Negotiate the financial side of transitions carefully so that the incumbent CRO can complete tasks within given time constrains instead of relying on the new CRO to do so

About Rho
Rho, a privately-held, contract research organization (CRO) located in Chapel Hill, NC, provides a full range of clinical research services across the entire drug development process. For more than 25 years, Rho has been a trusted partner to some of the industry’s leading pharmaceutical, biotechnology, and medical device companies as well as academic and government organizations. Our commitment to excellence, our innovative technologies, and our therapeutic expertise accelerate time to market, maximize returns on investment, and lead to an exceptional customer experience. For more information, visit www.rhoworld.com.

SOURCE: Rho