Promedim: The Roadway to Seamless Medical Oversight of Clinical Trials

Insufficient medical oversight of clinical trials is a primary scrutiny of regulatory authorities and a common reason for major/critical audit findings. Provision of 365/24/7 coverage by expert physicians can be expensive and arduous for sponsors to perform and demonstrate that they can do so robustly.

We conversed with Hugh Devine, (Director of Business Development, Promedim) to find out how his firm can help life sciences companies provide this oversight in the most compliant, transparent, and cost-efficient manner.

According to you, what are the challenges companies in the clinical trial space are grappling with?

There are two perspectives to that question. One is the inability to comply with regulatory mandates for medical oversight and secondly, the lack of a technology platform that can help companies efficiently meet regulatory compliance.

As per the ICH E6 5.3 guideline, medical personnel trained in relevant therapeutic areas should be available around the clock to answer any study-related question. Herein lies the challenge. Many companies have sites distributed across the world, yet the medics are mostly based at a particular geographic location. This happened with one of our biotech clients that had 32 sites globally but had medics based in California. In such cases, the medics will only be available during work hours, usually from nine in the morning till five or six in the evening, after which any trial-related questions will remain unanswered. The other part is that it is not acceptable to just have a spreadsheet with a list of medics, and their phone numbers, and say you have 24/7 coverage. A trial sponsor must also be able to prove those medics’ availability. In addition to ICH, there are FDA guidelines such as 21 CFR Part 11 which is all about e-signatures, mandatory documentation for protocol changes, control of electronic records and the ability to document and prove compliance.

Our solution is designed with such regulatory rigor in mind whilst offering transparency to the sponsor and ease of use and coordination for the on-call medics.

Where does Promedim fit in the picture?

The first part of what we do is offer medical services. It is for companies who don’t have in-house medics to support a clinical trial or need assistance in augmenting their in-house team’s ability in rendering around-the-clock medical coverage. Our medics are spread across the globe, covering multiple time zones and varied specializations. They can effectively answer any question pertinent to their domain. The second part is the technology we bring to the market. Our proprietary medical monitoring app, promedim24, is in simple terms a platform that provides a log in and log out feature for medics to register their availability. It also serves as a central repository for all trial-related documents. This is important because trial documents such as protocols and brochures undergo several iterations during the course of a study, and our platform makes it effortless to find and use the latest versions. From a compliance standpoint, it is imperative that any changes in the study and the reason for making the change be documented, electronically signed, and fed into the audit trail. Our solution has the feature to document such changes and their underlying reasons, and there is an audit trail that can be tied back to the person who made the changes and when. We can also customize our services and solution to meet different customer needs. For example, we can provide translation services for many different languages.

The three components—medical services, technology, and compliance—are supported through cloud-based delivery. In fact, we are the only fully validated, cloud-based medical monitoring technology and medical services provider.

Please shed some more light on the technology solution.

We have iOS and Android apps that allow medics to login and mark themselves as available. They are then able to receive calls and answer questions related to the study. Once their ‘shift’ ends they simply log out of the app and are no longer available to receive calls. This is centrally monitored by our control center who have access to the console 24/7 and can see who is available and route the call appropriately.

It granularly records the availability details of medics, time of log on, time of log off and calculates the duration of availability.

In case of an audit, a client can dynamically generate a report based on date range; anything from three days or three months. This report shows day-by-day details of each medic in a given trial and the levels of coverage they provided.

The next is what differentiates us in the market.

The system of routing a call/query to a medic upon need was vastly manual; a control center would dial telephone numbers of medics taken from a long list, unanswered calls went to voicemail and then move onto the next number in the list. There is no way to check medic availability ahead of starting the calls so callers would be on hold during this process. But our technology is cloud-based. As soon as a query is raised (be it routine or emergency), our global control center accesses our promedim24 console to determine a relevant medic’s availability and routes the query in real time. If the call goes unanswered or the medic is busy, the control center can route to the next medic who shows as available in the console to ensure a “warm hand-off” is complete.

So, the solution is a one-stop-shop for many needs. It can record medic attendances, enable quick resolution of queries, and ensure that a medic has the most up-to-date information while answering questions. All of this is done in strict accordance with regulatory mandates and can be quickly presented when requested by a sponsor or an auditor.

Is there any case study you would want to mention?

I have three case studies. The first one is of a company that had over 50 medics spread globally and didn’t require our medical services. For them, the challenge was to effectively manage the availability of the medics. Our promedim24 app and the global control center that constantly monitors availability status of each medic, have vastly improved the efficiency of delivering medical monitoring as a service and we have been engaged with the client since then.

The next client, a small biotech company with limited medical resource was starting a global study. They required their Chief Medical Officer to be supported by Promedim’s medics to ensure global, round-the-clock provision with maximal cost effectiveness. The continuous medical coverage was demonstrated through instant reports accessed through our Promedim24 App.

Our final study best represents our hybrid model of working with a company’s internal medical team. An innovative biotech company, developing new medicines in the critical care setting, required immediate medical helpline support for investigators in a complex study. The support was focused on enrolling patients and helping to correctly titrate the study drug. Our 24/7 technology solution integrated the extensive company team with additional external medical resources to support sites around the clock on three continents. This enabled potential patients to be assessed by the sponsor in real time and drug titration to be managed in collaboration with the sponsor. The technology allowed coordination of the medical support team from the sponsor together with a CRO to ensure no calls were missed despite very high call volumes.

What is next on your corporate roadmap? Any new launches or expansions?

We are currently in the final phase of developing the next release of our software which will significantly enhance its communication capability. Calls and queries between a subject and a medic need to be properly documented and the next version will allow two way communications between the study site and medic. This takes place with the promedim24 app so is subject to the same level of security and compliance as the rest of the software. Sponsors can be confident in the knowledge that their medical queries are centrally stored in a fully encrypted environment that can be readily accessed when required. Each query is electronically signed and once completed, reports can be provided to sponsors and sites as required. At the end of the study, a TMF-ready PDF report can be produced at the touch of a button.