Designing and organising clinical trials for medical devices requires taking into account different specifications and regulatory constraints, making them more complicated than drug trials. Selecting the right partner with the specific capabilities needed to organise the trial supplies is key to the success of the trial.
But why is it so important and what do you need to take into account? Read on to learn more, and discover how to select the partner with the correct experience and expertise for your unique trial.
While new drugs always require a clinical trial, the risk stratification (or class) of the medical device determines if one is needed. Whether you are in the US or EU, which device class requires a trial varies. Drug trials typically start with a small group of healthy volunteers and gradually grow bigger, while medical device trials involve smaller groups with the disease or condition under study. Safety reporting requirements for devices also differ from those for drugs.
Adding to the complexity, the rapidly changing regulatory landscape for medical devices is not the same in the US and the EU.
Selecting the right partner to organise the trial supplies needed to conduct a successful trial is key to bring a device to market and help the patients who need it. In-depth vendor qualification focusing on these three qualities will ensure the most suitable fit is identified for the trial:
Being able to adapt to changes and having a flexible approach are essential. A close relationship with a supplies expert that has the relevant experience within medical devices to manage any specific medical device-related processes will ensure the trial runs smoothly.
As with all clinical trials, the focus must be on the patient. They are dealing with a disease or condition that the device has been designed to alleviate, or even cure. Specialized service solutions like Clinigen Clinical Supplies Management’s Direct-to-Patient (DtP), a patient-centric and novel approach to the clinical supply shipping process, can help ensure smooth delivery, patient retention and compliance, providing the patient access to the device and significantly improving their experience.
Working with a supplies partner that has extensive international experience with labelling, distributing in different countries, logistics, providing ancillary supplies, and managing carriers and inventory, can only be an asset. They must also be used to dealing with regulatory specifications for medical devices.
The ability to provide a comprehensive supplies strategy with effective solutions greatly increases the ability to conduct a successful trial on time and within, or even under, budget.
With more planning involved in medical device clinical trials, choosing a partner that is willing and able to cover all the steps and not cut any corners makes all the difference. Being proactive and flexible ensures that they can deal with the wide range of medical devices being developed, and take into account all the additional steps required such as putting together the parts received and delivering the ready-to-use device to the patients.
With over twenty years’ experience in clinical supplies and having managed major medical device projects, Clinigen Clinical Supplies Management has the expertise, commitment and agility needed to tailor its services to the specifications of each unique medical device trial.
How can our customised and innovative solutions help your project?
Schedule a 20-minute, no-cost consultation with one of our clinical supplies services experts.
As a leading provider on a global scale, Clinigen is committed to delivering fully integrated logistics services to our clients. Over 80% of the studies we are supporting are multi-national and we organise shipments to 110+ countries.