Strategic considerations for choosing the right CRO partner for your clinical trials and PMCF studies.
Over the past decade, medical device and diagnostic companies have increasingly turned to clinical research organizations (CROs) for product development services. The outsourcing of clinical trials or PMCF activities is often a strategic move that enables device companies to leverage the CRO's infrastructure to manage the clinical development process and navigate increasingly complex regulations.
By partnering with a specialized CRO, device and IVD companies can focus on their core competencies of developing devices and diagnostics rather than building complete clinical teams internally. This strategic approach allows organizations to accelerate their development timelines while ensuring regulatory compliance.
As a starting point, a clinical research organization should ideally have expertise in your product type and therapeutic area. However, increasingly important as regulations become more complex is for a CRO to apply appropriate regulations and standards customized to your project that meet the specific needs of your product and company goals.
When evaluating potential CRO partners, consider the following:
Eclevar MedTech has a team of experts who are former leaders of competent authorities and notified bodies and can help navigate the complexities of regulations. We recommend reviewing the professional credentials of the project team and support of executive management at an early stage in project discussions.
Ensure the CRO holds relevant quality standard documents including ISO 14155 (European regulation), ISO 9001, and ISO 13485 to guarantee compliance with regulatory requirements.
Does the CRO have global capabilities and partnerships for your target regions? Full-service capabilities including CTMS (Clinical Trial Management System) support provide significant project efficiencies.
Compare unit costs and line items rather than overall costs. Ensure transparency around pass-through costs which can significantly impact final project expenses.
Verify the CRO's expertise in your specific regulatory pathway. Former competent authority and notified body leaders bring invaluable regulatory knowledge.
Consistent project team members throughout the study duration ensure continuity, institutional knowledge, and better project outcomes.
Specialized knowledge in your therapeutic area (orthopedics, wound care, cardiovascular, etc.) ensures nuanced understanding of your product requirements.
The quality of work is directly linked to compliance with regulations. It is important to ensure that your medical device CRO or IVD CRO holds the relevant quality standard documents:
These certifications demonstrate the CRO's commitment to maintaining rigorous quality standards and regulatory compliance throughout all project phases.
When evaluating a CRO's clinical trial capabilities, consider:
Studies often involve working with several vendors, so having the full-service capabilities of a clinical research organization will help streamline operations and reduce coordination complexity.
Cost is often a key factor in selecting a clinical research organization. However, it's critical to compare costs appropriately:
This process can be managed by implementing a standard comparison framework when assessing clinical research organizations. Establishing the same expectations and scope of work for medical device CROs to respond to ensures you're comparing apples with apples.
Global medical device clinical research organizations with well-known names can be experienced in working with pharma trials. However, medical device trials have particular requirements which sometimes become unclear when resources are shared across projects, potentially impacting the quality of work due to staff not fully understanding the nuances of medical device trials.
Frequently, sponsors approach large companies with famous names feeling it's a safe choice and derisk the project. However, they often experience disappointment when encountering significant churn of project managers over the duration of the studies. The holistic approach can be lost as larger companies tend to compartmentalize their operations, and extra layers of fixed costs are often passed on to the sponsor.
A boutique medical device CRO can offer a potentially more reliable service proposition:
Sponsors have quick and easy access to operations and executive management teams to provide a personal, highly responsive, and customized service at all times. This can be important when study issues need to be identified quickly and the project team can be available to address questions and provide frequent updates.
The process for selecting an IVD CRO for a medical device company is very similar to selecting a general medical device CRO. However, there are important nuances worth considering:
This expertise will help diagnostic companies navigate the regulatory pathways, particularly for IVDR. Operations teams ideally need to have project managers and CRAs with direct IVD experience to ensure quality and address these considerations appropriately.
Eclevar MedTech has dedicated IVD experts who can provide a tailored approach to this segment to ensure quality and address these considerations in the right way.
In today's challenging economic environment, cost will always be a key factor in selecting the right CRO. However, it should not be the only factor. Consider the complete value proposition:
These factors are critical to the success of your project and will ultimately provide better value than selecting based on cost alone.
Selecting the right CRO partner is crucial for your clinical trial success. Our team of regulatory experts and experienced project managers is ready to discuss your specific needs and how we can support your clinical development program.
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