In the clinical study process, medical imaging is becoming more common as primary and surrogate endpoints in clinical trials, that’s why an Imaging Contract Research Organization (ICRO) can be a key asset to your clinical trial team. At its core, an ICRO will manage and read medical images on behalf of a trial sponsor. They bring ongoing project management and support services to the sponsor and ensure investigator sites are trained and qualified.
Imaging vendors are important partners in your clinical trial: providing a wealth of ongoing support and medical imaging expertise at every stage, from imaging protocols, state-of-the-art image acquisition, quality control, analysis, to data management.
To ensure you select the appropriate partner for your clinical trial, here are four important factors to consider:
1. Breadth of Scientific Expertise and Experience
ICROs often lead the way in implementing new technologies and process improvements that increase the efficiency and quality of clinical development, and ICROs are no exception. As imaging technologies are advancing quickly, it’s important to select an imaging vendor that not only has experience in handling more complex modalities but are actively innovating in anticipation of new ones. For example, nuclear medicine methods like PET or SPECT exams are becoming more common in oncology, but some vendors may have difficulty managing those modalities.
Similarly, the track record of your ICRO is crucial: how many trials have they worked on? What is their experience in managing image workflows across global multicentric trials? Have they worked in the relevant disease indication before? Imaging vendors that have worked on a wide range of trials will have access to a rich resource of expert medical teams, and they can bring their expertise to your trial, too.
A further consideration is to ask whether your potential vendor can offer support and consultancy from the beginning to end of your trial. This is essential when your organization has no in-house imaging expertise. This can help with design of the imaging components of the trial including writing Imaging Review Charters and standard image acquisition manuals. Should any imaging issues arise it’s valuable to be able to seek advice from the vendor to help solve them quickly. Their availability and flexibility are also important criteria and must be considered when choosing the right vendor.
2. Approach to Quality Assurance
Image standardization is an ongoing issue, and this is where an ICRO’s expertise can play a crucial role. By providing a standard imaging acquisition manual in advance and working with sites to ensure all of them can follow the manual’s requirements, you’re reducing the risk of variability and increasing your trials chances of succeeding from the beginning. One of the questions to ask your ICRO at this stage is, what is the process for site selection or qualification? And how will the site be supported throughout the trial?
It’s important to ascertain the ICRO’s approach to reader selection and training. To produce precise, consistent and reproducible imaging data in trials, all efforts must be taken to reduce bias and variability that can lead to larger sample sizes (and longer studies) being required. Your ICRO should have a system and process in place to assess and manage intra- or inter-reader variability. In addition, they may be able to advise on incorporating certain design features into your trial to minimize bias and increase precision of observer-dependent endpoints.
Another important aspect to consider is the transfer of imaging data which needs to be compliant with 21 CFR Part 11 FDA regulations on electronic records and electronic signatures. This means ensuring that any systems being used to manage electronic records have been validated and have features such as audit trail functionality, and that there are standard operating procedures in place for the management of this data. Choosing an ICRO that provides regulation-compliant integrated software to manage your imaging data will help to navigate this component of quality assurance.
3. Technical Capability and Flexibility
An important aspect of choosing an ICRO is to consider the technical capability and platforms on offer. Here, there are three main components to consider.
First, does the ICRO use an integrated system for all aspects of the imaging workflow – upload by sites, storage, and analysis? Using multiple systems for these stages introduce errors and is far less efficient. By contrast, with integrated systems, clinical study sites upload patient images, which then remain in the same online platform throughout the quality control, online reading session and all query and data management steps involved. An integrated system also allows project managers and study coordinators to react quickly to issues should they arise.
A second consideration is whether an ICRO uses its own in-house software. This is an advantage because the vendor does not have to rely on third party suppliers and can prioritize the work that needs to be done. Project managers and technical experts will be located next to each other, ensuring great communication. This helps ICROs react quickly to any issues with the workflow and can also help to customize software to specific projects.
Finally, it is worth looking into the user interface of the technology on offer. As CRO or sponsor, is it straightforward for you to access the imaging analysis platform? Think about what you might need to report on throughout the trial, and check that the platform’s reporting capabilities meet the need of your organization.
4. Are They the Right Fit for You?
It’s essential to build a relationship with your ICRO that’s based on confidence and trust from the outset. That’s why it can be helpful to carry out due diligence on the company before you embark on that relationship.
In addition to researching the vendor’s track record (how many studies, how many years’ experience do they have, how many approvals), it’s essential to find one that is financially stable and to check its regulatory history (FDA/EMA audits, for example). Does it have a track record of profitability and growth, and from how many clients?
It’s equally important to consider the ICRO’s corporate culture and strategy - how flexible is the organization? Is there easy access to senior management in case of issues? Are they investing in R&D? An ideal ICRO will become a partner who is invested in making your trials a success, so you must ensure they will make a commitment to your business, and not de-prioritize you when new business comes along.
A small to midsize ICRO could be preferred in order to get enough attention or specific expertise, but this needs to be balanced with whether it has enough capability and scale for your trial. Given both the increasing complexity and global nature of clinical trials, it’s key to choose an ICRO that is large enough to offer scale but focused enough to do its core business well.
When considering partnering with an ICRO there are four main areas that you should be asking questions about:
- Does the ICRO have the required experience and subject matter expertise to support you from trial set-up all the way through to submission? Will they be on hand to consult with?
- What is their approach to ensuring high quality imaging data acquisition and analysis – and what is their system for dealing with issues that arise?
- Can the ICRO’s technology support the requirements of your trial – and is it flexible enough to be customized to your needs?
- What is the structure, culture and strategy of the ICRO – does it fit with the long-term partnership you require for your business?