We are delighted to host Pascal Winnen, Founder & CEO of HEMEX, a swiss-based Contract Research Organization (CRO) for this episode in our mm.Blog. Pascal and one of our founders, Florian, give an outlook on how digital tools shape the realization of clinical studies in our new dynamic virtual world.

Given the industries demand to digitalize clinical workflows and enhance clinical data quality and accessibility, how do you describe the state of clinical studies today and in the future?

Pascal: “It may be considered somewhat ironic that the healthcare sector, which is so innovative and fast moving, is still hesitant to embrace the novel virtual clinical trial culture which has now become our reality. The global pandemic has been a driving force in demonstrating how we need to adapt and find new solutions to conduct and monitor clinical trials.

Tools such as Electronic Data Capture (EDC) systems have been instrumental in helping us make the transition to working remotely yet still enable us to collect vital data. EDC platforms allow physicians to enter patient data and for monitors to check that all the information has been recorded correctly. If an error has been made, a quick alert can be raised directly in the system and the problem resolved by the study coordinator. Having access to an EDC platform ensures that everything can be done in real-time and with very high data quality.”

Florian: “From a sponsor’s perspective clinical studies are probably the most complex projects to demonstrate safety and effectiveness throughout the life cycle of a medical device or treatment. Innovation in healthcare currently faces two overlapping challenges. On the one hand, with the MDR in place the requirement for sufficient clinical data has become even more important. On the other hand, the global pandemic creates a big obstacle drastically slowing down site selection, patient recruitment due to postponing elective surgeries, and additional hurdles for source data verification.

Handling the pandemic carves out resources from clinical infrastructure and staff. As time and dependencies always have been a crucial part in clinical project management, any tool that simplifies time consuming workflows involving various parties is a big help. Simple tools such as DocuSign are still not the baseline even though they have demonstrated data security long ago and are commonly used in many sectors.”

How would you describe virtual studies, preferably where does virtual stop and on-site physical presence begin?

Pascal: “There have been many technological advances enabling ‘eClinical’ platforms to establish themselves and assist sponsors, CROs and PIs to all work together virtually. However, work still needs to be done to make these platforms easy-to-use, interconnected and affordable to all those engaging in clinical trial activities.

Ethics Committees have been releasing new guidelines on conducting studies during the pandemic. They will hopefully continue to realize how using technology can enable better, more accurate data capture to support their decision making. There have also been concerns raised over data protection laws and requirements as patient data is entered and stored in locations on the internet.

Going forward, we must work together to establish new norms and standards whilst ensuring clinical trials don’t compromise patient safety and wellbeing. From a legal perspective, electronic signatures, for example, are still not accepted on patient Informed Consent Forms (ICF). In the coming years, this will probably become the new norm and we can all play a role in sharing the advantages and find innovative solutions to prevent misuse.”

Florian: “There has always been a gap between the potential new technologies offer and implementing and realizing their benefits. But when it comes down to the question paper-based vs. digital, the dice have been cast long ago. Today an increasing percentage of healthcare is already engineered, thought and provided digitally. In addition, concepts such as value-based healthcare emphasize patient outcomes and call for more data to track these outcomes along the patient journey. It becomes apparent that clinical studies for innovative treatments incorporating a new ‘digital DNA’ are easier to conduct and monitor virtually.

As interconnectivity in healthcare increases and more clinical data becomes available, data capture and data security are key. Therefore, health authorities and care providers play a crucial role in shaping the ethical and regulatory framework for this evolution. Developments such as ‘smart hospitals’ are fertile ground to innovation in healthcare and more than just a buzzword. Simultaneously, virtual care blends into on-site physical presence, a shift that can already be seen in telemedicine.”

Siteless Trials: Can patients take part in a clinical trial from home?

Pascal: We frequently hear the term ‘Siteless Trials’, which still seems futuristic but is not far from becoming our next go-to method of conducting certain clinical trials. When patients enroll in a clinical study, it can be a daunting process, with many checks, examinations and forms to sign. All these checks are of paramount importance, however, there is scope to improve the patient experience and collect accurate data using other methods which will still support the future successful market launch of the medical device in question.

Using technology, such as wearable devices, could enable physicians to access real-time data collected directly from patients whilst at home. One may ask whether it is really necessary for a patient to travel to the hospital for a check-up 12 months after they’ve undergone a procedure to take their heart rate, blood pressure measurements and have them complete a survey? Putting the patient first when designing trials could encourage more people to participate if there was more flexibility and remote monitoring.

With most patients having access to a mobile device, using apps to collect real-time data is becoming easy. For example, a patient can now effortlessly record an Adverse Event in a couple of seconds on their phone and help patients in the future suffering from similar symptoms or side effects.

Giving patients a ‘voice’ on a platform where they can tell you how they are feeling improves data quality and patient safety. Along the same lines, sponsors can give patients updates via such online platforms to maintain engagement and share the most up-to-date information about their treatment.

Florian: Pascal just outlined the potential benefits that smart devices offer, but many sponsors do not fully acknowledge their added value yet. Sure, they may not be applicable to every medical device or treatment and not every piece of information captured by clicking a button is relevant for the outcome of a clinical trial. However, any technology that enables virtual data capture might add another valuable data dimension that we may have missed in the past or, to some degree, is closer to real world evidence.

“You’re on mute”: Interaction between CRO and Sponsor

Pascal: All-in-all, the global pandemic has made us realize that we can change and do things differently. As a CRO, HEMEX has adapted to our client’s needs and is ready to plan and conduct clinical trials worldwide. We have established a new process, enabling us to conduct Site Initiation Visits with hospital teams virtually. With our colleagues at medical magnesium, we organized a virtual project ‘kick-off’ meeting so that both teams could get to know each other. We have regular weekly meetings to give progress updates and answer any questions, give advice, etc. We hope that we will soon be able to travel to Germany to meet the medical magnesium and the clinical hospital teams with whom we work closely on their two PMCF studies.

All in all, the COVID-19 pandemic has allowed us to reflect and make positive changes. Each and every one of us can now play a small part in transforming the way clinical trials are conducted today and in the future, to make sure that patients are at the forefront of everything we do.

Florian: Conducting virtual clinical studies is an interesting mission statement, especially during the pandemic. At medical magnesium we are at our best in the operating room or wet lab to derive our clinical pathways together with passionate surgeons simply because we are a physical medical device manufacturer. In a post-pandemic time, we will still depend on on-site clinical activities to a high degree and procedures such as arthroscopic surgeries will still be done by highly trained surgeons. Our implants enable a ‘single surgery therapy’ which is closely monitored throughout our PMCF studies. Hence, we would love to invite the CRO team to introduce them to investigators, surgical techniques and corresponding aftercare. As soon as traveling becomes possible again, we will catch up on physical investigator meetings together with our CRO to fully take their experience and perspective into account. In the meantime, we implement digital tools whenever possible.

About HEMEX
HEMEX is committed to changing the future of healthcare by guiding the most promising European start-ups through each and every step to bring innovative pharmaceuticals, medical devices and in vitro diagnostics to the market. Headquartered close to the thriving Basel global Life Sciences hub, the goal at HEMEX is to ensure start-ups have access to a wide range of tailored products, practical solutions and fundraising support, either in-house or via our network of pre-qualified experts, laboratories, CMOs, warehouses, logistic partners and affiliates. This empowers the next generation of transformative discoveries to grow into successful and sustainable businesses, and drive change in both human and animal healthcare. Find more information on www.hemex.ch