By Efraim Roe, executive director of medical devices, and Patrick Young, executive director of clinical monitoring services, Premier Research Group
Medical device companies are outsourcing a greater number of product development services to CROs. The rationale to outsource is typically a strategic decision allowing device companies to take advantage of the CRO’s established infrastructure to efficiently manage the clinical development process and ensure that the latest regulations are being followed. This allows them to focus on their own core strengths of developing devices, rather than having to build, implement, and manage an entire clinical team on their own. CROs offer a number of benefits, and by leveraging a CRO’s expertise of product development, knowledge of regulatory requirements, and established processes and systems, significant efficiencies in product development can be realized.
Choosing A CRO
Choosing the right CRO is critical to a project’s success. When choosing a CRO, it is important to evaluate the core competencies of different CROs by reviewing them on the same spectrum of parameters (comparing “apples to apples”). This process can be easily managed by setting the same expectations across all CROs being assessed in the process of an RFI (request for information) and/or RFP. By following a standard comparison process, the company should provide the same set of questions and scope of work for CROs to respond.
RFI/RFP Focus Items
In selecting the right CRO partner, it’s important to consider the following criteria:
Quality — Quality work is directly linked to compliance with regulations. Ask about the quality certificates that the CRO holds. When it comes to medical devices, make sure the quality standard certificates that the CRO holds include ISO9001 and ISO13485 and reference ISO14155 (European Regulation) and 21CFR (FDA regulation). Review the CRO’s processes, and ensure that the different departments within the CRO communicate and have transparencies in their operating model. It is also important for the CRO to have an independent Quality Assurance department to provide assurance of the work being delivered with the highest quality.
Experience — Check the CRO’s relevant therapeutic experience, and request a client reference list. Insist on seeing the credentials (experience and background) of the project team being proposed, and confirm that the team is supported by involved executive management.
Capabilities — Assess the CRO’s global capabilities (including partnerships) throughout the regions the study will be performed. Managing several vendors might prove to be difficult, so it is often best to use a CRO with full-service capabilities. All operating systems used by the CRO should be transparent and linked with each other, preventing duplicate activities. Check to see if the CRO is using a CTMS (clinical trial management system) platform. This will offer efficiencies and provide current status of project metrics.
Cost — Cost is always a factor in selecting a CRO. When comparing different bids for services, it is important to compare unit costs/line items and not just total cost. Challenge the assumptions made, and you will see that in some cases CROs may provide a low-cost proposal that does not account for all study specifications and may lead to numerous change orders once the study is under way (resulting in higher unexpected costs).
While there are many CROs, choosing the right CRO partner for your company or project can be challenging. It’s important to consider all resources and services required to successfully deliver your project.
In the current economic environment, cost will be a determining factor in choosing the right CRO but it should not be the only factor. It is important to take into account quality, the experience of the team, and the CRO’s capabilities in order to maximize an outsourcing partnership.