PMCF INVESTIGATIONS

The importance of entrusting the responsibilities of managing clinical investigations, including PMCF investigations, to knowledgeable and experienced individuals cannot be overstated.

 Clinical investigations are complex and the data they generate must be ethically and scientifically valid, reliable and robust.

THE RIGHT PARTNER

As a medical device manufacturer, it is important to look for effective ways to conduct testing more efficiently and within budget: this is a mission you can entrust to a contract research organization like Eclevar.

REQUEST FOR QUOTE

Choose Eclevar as your CRO partner to support your PMCF investigations.

questions arising

Once you have received approval to take your device to the clinical stage, many questions you need to answer will appear, including:

– What are the right endpoints to collect and report to best support my trial objectives?
– How do I identify and qualify preferred sites to ensure successful study recruitment and compliance?
– What is the best patient population and how can I motivate patients to participate in my trial?

Doctor

PMCF common errors

If not conducted properly, errors could jeopardize the success of the medical device for which they are conducted, such as its entry into the market or its continued presence.

PMCF studies often have the following errors, for example:
– they do not cover all indications;
– They do not have primary endpoints that are clinically meaningful;
– they do not cover the lifetime of the device;
– study designs are based on poor statistical design;
– there is an overestimation of study numbers;
– the interaction between accessories and devices is not considered in the PMCF.

Trust and expertise

The importance of entrusting the responsibilities of managing clinical investigations to knowledgeable and experienced individuals cannot be overstated.

Clinical investigations are complex and the data they generate must be ethically and scientifically valid, reliable and robust.

Hospital partners

trial site identification

The selection of the clinical study site(s) is a crucial step in the planning of any clinical investigation and has a significant impact on the success of the study. Inappropriate site selection can lengthen the duration of a clinical study and, in the worst case, lead to project failure.

Often, manufacturers sponsoring a clinical study identify a Key Opinion Leader, but do not adequately evaluate the KOL’s clinical site to ensure that it can recruit study subjects at an acceptable rate and that it has the resources to provide the required services in a timely and compliant manner.