A Questions-Based Guide to Choosing a CRO

ARG offers a comprehensive suite of global service solutions, built on industry-leading technologies and tools, and backed by our signature customer attention.

ARG thrives in complex protocols and intricate clinical trials because we have been successfully operating in both challenging one-off trials without well-defined blueprints, as well as large scale and global programs. We demonstrate that level of flexibility by relying on a diverse long-standing team of in-house experts who know to cultivate active partnerships with our sponsors. We ask questions, gather facts and opinions, and build consensus to deliver industry-leading functions.

We believe sponsors should ask questions as well, especially when choosing a CRO. Here are a series of key questions to pose in strategic areas of clinical trial management:

Clinical Operations

  • Does your CRO go to great lengths to understand specific therapeutic areas?
  • Does your CRO evaluate a protocol from a patient perspective?
  • Does your CRO care about site success?
  • Do your Project Managers take on client goals as their goals?
  • Does your CRO provide the right resources at the right time based on your study needs, or just tell you they have 80 CRAs available?
  • Does your CRO actually prioritize your study, or just tell you they do?

Data Management

  • Are you confident of your CRO’s commitment to drive, build and lock timelines?
  • Does your CRO support EMR data direct to clinical database collection?
  • Does your CRO support remote SDV and virtual clinical trials for our changing landscape?
  • Are your protocol amendment database updates completed quickly and seamlessly?
  • Does your CRO prioritize CRA and DM collaboration/communication?
  • Do your Data Managers understand site priorities in collecting patient data?

Biostatistics and Programming

  • Does your CRO use offshore SDTM teams to create SDTM data?
  • Does your Stats team typically get involved in the database build and study start-up tasks?
  • Does your CRO underestimate the amount of work required then ask for change orders to drive profits?
  • Have your CRO Biostatisticians represented Statistics in regulatory submissions throughout the approval process and lifecycle management?
  • Is your Biostatistics team committed and engaged in your clinical studies?

Quality Assurance

  • Does your CRO perform internal quality audits of their own departments?
  • Does your CRO include dedicated QA personnel on their study teams?
  • Does your CRO’s QA department have input to all aspects of your project from study plans to database review?
  • Does your CRO have the capabilities to allow for remote audits?