Choosing the right Contract Research Organization (CRO) is crucial for successfully navigating the ever-evolving and increasingly discriminating medical device approval process. The right choice can help deliver your product to the market efficiently and economically. The wrong choice can lead to trial failure, significant financial loss and even potentially damage to your company’s reputation.
Unlike pharmaceutical trials, medical device companies are ultimately responsible for the quality of the trial-related duties of their chosen CRO, according to the International Conference on Harmonisation, Guideline for Good Clinical Practice (1997). This responsibility makes it imperative that medical device companies have thoroughly reviewed their chosen CRO’s quality assurance processes and found that they satisfactorily align with their own quality demands.
The International Organization for Standardization guidelines for good clinical practice state that trial sponsors also must ensure that the CRO’s standard operating procedures meet their quality standards and are strictly followed throughout the process (ISO 14155:2011(E)4 section 8). With these inherent responsibilities, medical device companies must complete thorough due diligence when selecting a CRO, and choose one that displays a lengthy background of prior approvals, has glowing reviews from previous partnerships and has quality assurance processes in place that they trust will ensure strict adherence to best practices.
However, in their eagerness to get trials underway as quickly as possible, some medical device companies can make mistakes in the CRO selection process. These include choosing a CRO based solely on price or the fact that they have worked with the CRO in the past and avoided disastrous results. Selecting a CRO on the basis that they submitted the lowest bid could later result in the revelation that they lack the necessary tools or experience, which slows trial progress and can result in significant unexpected costs once the trial is underway.
Choosing a CRO that your company has worked with in the past can be tempting, but in the current rapidly-evolving regulatory environment, it is necessary to consider whether another CRO might offer better results. Unfortunately, most companies do not think to review other options until their long-standing CRO has created issues, or they find that they do not have the expertise to handle the advanced imaging demands of their novel technologies.
To avoid these mistakes and identify the ideal CRO to meet the imaging needs of your trial, it is important to involve them at the very beginning of the process. If CROs are consulted at or before the product development stage, medical device companies can avoid the frustration and costs associated with a compromised trial by ensuring that processes and quality assurances are sufficient before testing begins. This extra time also allows a sense of trust to build between the two organizations, as they get to better understand one another’s vision, capabilities and potential.
At Medical Metrics, our services include imaging protocol development, medical image management, independent image review and scientific consulting. We have helped numerous companies both large and small find approval and success in the marketplace and are set apart by out commitment to the highest standard of quality and reliability. We welcome an opportunity to better illustrate our capabilities and how our imaging expertise can meet your trial’s needs.
