Need Help? Chat Now With a Live Representative!

A Questions-Based Guide to Choosing a CRO

A Questions-Based Guide to Choosing a CRO

A Questions-Based Guide to Choosing a CRO

October 21, 2022

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?
ARG and Humacyte Collaborate on Human Acellular Vessel (HAV) Program Advancements in Vascular Trauma

ARG and Humacyte Collaborate on Human Acellular Vessel (HAV) Program Advancements in Vascular Trauma

CHARLOTTESVILLE, VIRGINIA – ARG (Atlantic Research Group) proudly announces its ongoing collaboration with Humacyte, a leading biotechnology company, on the […]

February 23, 2024
Revolutionizing Treatment: Our Contribution to Humacyte’s Latest Innovation

Revolutionizing Treatment: Our Contribution to Humacyte’s Latest Innovation

In 2014, ARG began working with Humacyte on their Human Acellular Vessel (HAV) interposition graft program, which included three separate […]

February 7, 2024
Curiosity and Communication Drive ARG’s Partners Towards Success

Curiosity and Communication Drive ARG’s Partners Towards Success

After leaving her role as a small-town pediatrician in Georgia and spending time at home with her children, Dr. Jen […]

January 24, 2024
GO TO TOP