1) Managing a Clinical Program with Limited Resources
So you're a medical device start-up preparing your first trial. Managing a clinical program with limited resources can present a multitude of obstacles at the best of times, regardless of whether you're med device start-up or a small biotech company. With a small staff operating on a tight budget, running a trial completely in-house is rarely an option. Therefore companies must establish internal core competencies, while deciding what aspects of their trial needs to be outsourced. When selecting a vendor, sponsors must find a CRO who will care for their project, first and foremost. They will also need to take advantage of their vendor's expertise while looking to streamline internal SOPs aligning them with that of theirs. Sponsors should maintain control of site selection, ensuring the site has everything it needs and the staff know how to handle the device (more on that later).
On top of using your CRO's expertise to your advantage, sponsors should make the most of their resource capacity for trial execution. In the case of a small med device start-up with fewer staff, overseeing operations at various sites can be a logistical challenge. Nevertheless, it is vital sponsors safeguard the integrity of their trial by regularly auditing vendors and sites. Be sure to maintain control of project execution.
2) Preserve Flexibility
If developing a protocol internally, be open to receiving consultation from medical advisors, investigators, statisticians, and CROs. Define your regulatory strategy with input from a consultant or CRO. It's key that once the trial is underway, sponsors remain flexible throughout the course of the study. They should anticipate numerous changes, such as device iterations and protocol amendments. If you plan on conducting your trial in a foreign country, understand its standard of care as well as the country's patient population. Furthermore, sponsors should be aware of the regulatory environment they're operating in as many barriers could present themselves unexpectedly. To that end, when it comes to global studies, one way to insure success is by partnering up with a CRO that has country-specific knowledge and expertise.
What's more, it is essential the CRO understands the local culture; just because they speak the language does not necessarily mean they understand the culture. Determine what site management model works best for the study (will you adopt a global project leadership model or a regional one?). Take advantage of your CRO's global experience before establishing areas of responsibility.
3) Working with Vendors who only have experience in drug clinical trials
Oftentimes, small med device companies will rely on their CRO to provide expertise. But what do you do when you find a vendor that's an ideal fit, but doesn't have device experience? While the vendor of your choice would ideally have the requisite experience you desire, if the sponsor has sufficient device trial knowledge and the vendor has demonstrated they are more than competent at running trials, then device experience isn't essential.
In the event you pair up with a vendor without medical device experience, review your vendor's SOPs and processes, and identify what requires modification. Be sure to align your vendor's SOPs with the requirements of your device trial. In preparation of study start-up, glean what level of technical expertise will be required by site staff. Once you've done that, establish a device trial team and SOPs. Furthermore, sponsors should anticipate significant trainings that might be required; determine whether they need to learn about device trial regulations, the protocol, the device itself as well as its operability.
Lian Cunningham, Vice President, Clinical Affairs, Baronova – Strategic Considerations When Building a Clinical Program in a Medical Device Start-up Environment