Today, medical imaging CROs (ICROs) are more likely than ever to be a key asset in running a clinical trial. And, the clinical trials of which ICROs are a part are more likely than ever to be international and involve vast numbers of players. The amount of data that must be managed is growing daily, as is the pressure for ever faster turnaround times for that data. In this rapidly changing environment, how can a sponsor or traditional CRO be sure that its ICRO of choice is up to the task?
There are a few key elements to look for, and several important questions to ask.
Start with the basics requirements.
There are three basic criteria to consider in evaluating ICROs today:
- Breadth of scientific knowledge and experience
- Operational expertise
- Sophisticated platform technology
The first of these — scientific experience — speaks for itself. The other two require a few more words.
At a time when clinical trials are growing more and more complex, the ability to keep sophisticated global interactions and operations running smoothly is paramount. Any potential imaging partner must be able to provide a proven track record of success. Ask how many trials they’ve worked on or what their experience is in managing complex imaging workflows for multicentric international trials.
Sophisticated technology supports both operations and science. It also distinguishes adequate imaging partners from those who can bring exceptional capabilities and ease to a clinical trial. Medical imaging is a rapidly evolving, highly technical field. An ICRO must be fanatical about keeping up with the constant changes and planning for the future. Ask your candidate ICROs what differentiates them from their competitors. Ask what new capabilities they have added in the past year or are about to bring online.
Culture, Values and Attitude Matter
Traits and soft skills are difficult to assess, but can make all the difference in challenging situations. Take the time to establish whether or not your prospective partners are collaborative by nature. Do they have the ability and ready willingness to adapt to dynamic situations? Will they commit to supporting you 24/7? As your imaging partners, will they offer flexibility when necessary to help you achieve your goals? Will they bring urgency to the task of setting up your trial? Can you envision having a solid, productive relationship with this organization and its people?
And, finally, as good intentions are never enough, be sure to ascertain whether or not your prospective ICRO has the financial stability and resources to deliver on its promises.
To Conclude.
If imaging will be part of your clinical trial, engage an expert imaging CRO that can deliver everything you will need:
- Top-notch scientific knowledge and experience
- Project management and operational excellence
- End-to-end in-house technology, medical services, and reader management
- High-quality data with transparency and integrity
- A firm commitment to partnering with you fully from beginning to end
If you can be assured of netting all this from your ICRO, you will have taken a huge step toward securing a successful, efficient trial.
Some specific questions to ask and issues to raise regarding scientific experience, operational expertise, and platform technology.
Scientific experience:
- Are your physicians board certified?
- Do you have an international network of physicians?
- Do you offer scientific consulting services?
- Has the ICRO previously worked in this indication?
Operational expertise:
- Describe your investigator site training and support.
- Have you worked on international trials?
- Are your operational teams trained in GCP (Good Clinical Practice)?
- Describe your experience with regulatory authorities.
Technology platform:
- Is your platform an end-to-end central imaging platform?
- Do you offer an integrated read system?
- Describe your technical support services.
- Are you 21 CFR Part 11 compliant?
- Are you ISO certified?
