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Selecting a Medical Device & Diagnostic Clinical research organization

Considerations for selecting Medical Device & Diagnostic CRO    

Selecting a Medical Device & Diagnostic clinical research organization for PMCF study

Over the past decade Medical Device & Diagnostic companies have increasingly turned to CROs for product development services.

The outsourcing of clinical trials or PMCF activities process is often a strategic move that enable device companies to leverage the clinical research organizations infrastructure to manage the clinical development process and help navigate the increasing complex regulations and adhered to for such trials.

By doing this device & IVD companies can focus on their core competencies of developing devices & diagnostics rather than building complete clinical teams.

What should a medical device & diagnostic sponsor consider for selecting a clinical research organization for clinical trial or PMCF study?

As a starting point, a clinical research organization should ideally have the product type and therapeutic area of expertise for the sponsor.  However increasingly important nowadays as regulations become ever more complex is for a clinical research organization to apply the appropriate regulations and standards customized to the project that meet the specific needs of the product and company goals.  

Eclevar MEDTECH has a team of experts who are ex-leaders of competent authorities and notified bodies and can as a starting point help in  navigating through the complexities of regulations. Eclevar recommend seeing the professional credentials of the projects team and support of executive management at an early stage in the project discussions. 

Eclevar also has an international team of leading KOLs at leading hospital sites across all key therapeutic areas who provide medical oversight and expertise to projects.

Other key considerations for the selection of a partner for medical device & diagnostic CRO:

Quality

The quality of work is directly linked to compliance with the regulation. It is important to ensure that the medical device CRO Or IVD CRO holds the relevant quality standard documents ISO14155 (European regulation), ISO9001, and ISO13485.

A

Clinical trial Capabilities

Does the clinical research organization have global capabilities and partnerships for the regions where the study will be performed in? Studies often involve working with several vendors so having the full-service capabilities of a clinical research organization will help. Is the CRO able to provide efficiencies for a project for example in providing a CTMS (clinical trial management system)? 

B

Cost

This can be key a factor in selecting a clinical research organization. Comparison with other CROs needs to be comparable (i.e apples with apples) such as comparing unit costs/line items and not overall cost. Does the CRO provide transparency around pass-through costs which can often impact the cost of the clinical trial or PMCF study? If the project costs look very low have all the study specifications included as in future costs may increase significantly with multiple pass-through costs.

This process can be managed by the sponsor for setting the same expectations when assessing clinical research organizations in the process of RFI(request for information) and/or RFP. Implementing a standard comparison process can provide the same set of questions and scope of work for medical device CROs to respond.

C

Are global big medical device clinical research organization or IVD CRO the solution?

Global medical device clinical research organization with big names can be well versed in working with pharma trials however medical device trials have particular requirements which sometimes can come clear when resources are shared across projects and impact the quality of work due to staff not clearly understanding the nuances of medical device trials. 

Frequently an SME will approach a big company with a famous name feeling it is a safe choice and derisking the project however often they experience disappointment when experiencing a 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 cost are often passed on to the sponsor. This is where a boutique medical device CRO can offer a potentially more reliable service proposition.  

Eclevar is 100% dedicated to medical device & diagnostic trials and with stable expert teams avoiding churn of project members. Eclevar has few complex organizational structures with a lean approach which helps improvise the cost efficiencies project while being proactive and responsive. 

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 quick updates frequently.

Is the process different for invitro diagnostic (IVD)
companies to select IVD clinical research organization?

The process for selecting IVD CRO for a medical device company is very similar however there are nuances worth considering if the IVD clinical research organization has dedicated regulatory experts in IVDs. This will help diagnostic companies in navigating the regulatory pathways particularly for IVDR. Operations teams ideally need to have project managers and CRAs with direct IVD experience.

Eclevar Medtech has dedicated IVD experts who can help provide a tailored approach to this segment to ensure quality and address these considerations in the right way 

In summary today’s economic environment is challenging so the cost will always be a key factor in selecting the right IVD CRO however it should not be the only factor. Quality and experience of the team, IVD CRO capabilities, and maintaining a stabilized partnership with low churn of project managers are critical to the success of a project.

If you would like to discuss a project with us feel free to contact us

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