In the life science industry, there are biopharma companies who carry out clinical trials and there are specialized service companies who help with the production of these clinical trials. One of the most common types of pharma services business models is the contract research organization (CRO). CROs can specialize in a variety of clinical trial functions to help trial sponsors operate at a higher quality, and with deeper subject matter expertise.
Within the world of CROs there is a smaller and more specialized group of companies known as Imaging CROs. Imaging CROs acquire and read medical images on behalf of a sponsor or another CRO. Added to this they also provide a wealth of knowledge and expertise about medical imaging that can be applied to clinical studies. But first, let's discuss the value of using a CRO in general.
The Value of Using a CRO
CROs are the backbone of the clinical trial industry. It's often more efficient and cost-effective for sponsors to outsource clinical services, rather than incorporate the necessary infrastructure and expertise in-house. Indeed, it is established that CROs can reduce the cost of and increase the speed of clinical trials – clinical trials conducted by CROs are completed on average 30% quicker than those conducted in-house. Outsourcing also provides flexibility in human resourcing that sponsors often need.
CROs lead the way in implementing new technologies and process improvements that increase the efficiency and quality of clinical development. These include novel trial design, advanced statistical analysis and risk-based monitoring as well as improvements in patient recruitment strategies and site selection.
A CRO in general makes clinical trials more efficient and cost effective, and improves trial quality.
The Added Value of a Specialist Imaging CRO
Let’s now look at imaging CROs in more detail. Imaging CROs add a key asset to a clinical trial: the addition of specific knowledge about medical imaging. This includes expertise in imaging protocols, state-of-the-art image acquisition and analysis, data management and quality control.
Access to this knowledge is critical as medical imaging is such a vital component of many clinical trials. It can be used to stratify patients to the most appropriate treatments and as surrogates of clinical outcomes, and it can allow early measurement of treatment efficacy. Given this importance of imaging data, a specialist imaging company should be consulted. They have expertise and in-depth understanding of the complex medical technology that is needed to provide high-quality imaging services.
Data quality is at the heart of high-quality imaging services. This is achieved through several mechanisms by medical imaging companies. Standardization of image acquisition across sites and a focus on quality control (QC) of images ensures that the required data can be obtained from the images. A central read (a process by which the image interpretation is not done by the local study site) minimizes bias and subjectivity that might otherwise arise from the sponsor or study monitor's familiarity with patients.
The reliability and reproducibility of image data interpretation is realized through consistent data review (using standardized grading protocols) and the use of two readers. High quality data means faster, more efficient trials that reach completion sooner.
Partnering to Produce High Quality Imaging Data
How do imaging CROs work with sponsors? Medical imaging CROs offer highly specialized subject matter expertise to complement their integrated state-of-the-art products and services for the management of medical images in clinical trials. By providing these imaging services directly to trial sponsors, an effective and productive partnership can be built between a medical imaging CRO and a sponsor. The imaging CRO provides project management and support services to the sponsor delivered by leaders in medical imaging. The Investigator sites are trained and then qualified by the imaging CRO. This process is to ensure that they can manage the images according to recommended guidelines)
The relationship between the imaging CRO and sponsor is further strengthened through the use of shared tools, technologies and platforms to facilitate data management. For example, platforms that allow imaging data — uploads, QC and reads and so on — to be accessed in real time by a sponsor and their study partners. Together, these products and services ensures the trial runs as smoothly and efficiently as possible.
To Conclude
A CRO in general makes clinical trials more efficient and cost effective, and improves trial quality. If you are considering medical imaging in your trial, consult an expert imaging CRO that will:
- Apply their expertise and knowledge to provide high-quality imaging services
- Partner with a sponsor to provide state-of-the-art products and services to manage medical images in clinical trials
- Use technology to form effective partnerships with sponsors
- Produce high quality imaging data enabling trials to complete sooner
