In the rapidly evolving fields of pharmaceuticals, biotechnology, and medical devices, clinical research plays a pivotal role. Ensuring the integrity of clinical trials, adhering to ethical standards, and complying with regulations is essential. This calls for specialised expertise and a robust infrastructure, often provided by Contract Research Organisations (CROs). CROs are indispensable partners for companies seeking to navigate the complex regulatory landscape while staying at the forefront of innovation.
Leading the charge in this field is the European Cardiovascular Research Center (CERC). This distinguished organisation, driven by a team of accomplished physicians, not only secures regulatory approvals but strongly emphasises addressing critical patient needs. With a focus on improving patient outcomes and advancing European research initiatives, it stands as a beacon of expertise in clinical research.
Founded by seasoned physicians with extensive clinical research experience, CERC is guided by a team of esteemed medical directors. Their vision was to establish a reputable, high-quality, dedicated CRO in Europe. Its objectives include strengthening European clinical trials and academic leadership, acting as a global CRO, and providing support for emerging scientific leaders. The centre boasts an impressive track record in regulatory guidance, trial design, global study management, monitoring, and core lab activities for pre- and post-market drug and device trials.
At the forefront of CERC’s dynamic team is Marie-Claude MORICE, CEO and a visionary in cardiovascular research. Dr. Morice’s exceptional accomplishments, like the G.O. Hartzler Master Operator Award she received at TCT 2014, testify to her remarkable work. Her innovative spirit and forward-looking approach continue to shape the field.
As the organisation celebrates its 15th year, Dr. Morice’s leadership remains instrumental in driving innovation and excellence in clinical research. Insights Care had the privilege of interacting with Dr. Morice, gaining valuable insights into her impactful work in clinical research and her ongoing contributions through CERC.
Join us on an enlightening journey through CERC’s inspiring path of leading with innovation.
Empowering Excellence in Cardiovascular Research
CERC was established in 2008 under the guidance of influential European and international leaders dedicated to advancing cardiovascular research. Founded by a team of seasoned clinical researchers led by Dr. Morice, their collective goal is to elevate patient outcomes and promote the prominence of European research. Their combined expertise fosters seamless collaboration with industry partners and fellow medical research teams, focusing on pioneering techniques, concepts, and treatments.
Distinguished as a research institution with a wealth of clinical research experience, CERC stands apart, driven entirely by a team of dedicated doctors. Their commitment extends beyond regulatory compliance for new device approvals, as they actively address unmet patient needs within their trials. This unique approach sets CERC in a class of its own. With a vast network of over 450 high-quality recruitment centres, it provides invaluable guidance and logistical support for academic research endeavours.
CERC’s Expertise and Solutions
As a preeminent CRO, it offers a range of services in the field of cardiovascular research aimed at supporting clinical research related to cardiovascular diseases and facilitating the introduction of new treatments and therapies for patients. The services provided by CERC include:
Strategic Planning: This initial step is crucial for the success of any trial. CERC carefully considers every aspect of the trial, including development plans, regulatory requirements, and trial timelines, to ensure its success in the shortest possible timeframe. Strategic planning guides the overall project management and budget and should be undertaken early on to establish a clear vision for the project.
Regulatory Submissions: Clinical research success relies on a strong foundation of regulatory mastery, navigating a labyrinth of diverse guidelines, standards, and country/region-specific requirements. Adhering meticulously to the required format isn’t merely a formality; it’s the key that unlocks the gateway to a favorable review. CERC stands as a committed partner to study sponsors, providing strong support from the nascent phases to the final submission, ensuring the study journey through the regulatory landscape is not just compliant but above all accelerated.
Trial Management: CERC offers comprehensive services and expert guidance throughout the entire lifecycle of clinical trials and clinical data management. This can involve overseeing entire projects, from strategic design advice to the production of clinical reports or handling specific individual tasks.
Core Lab Services: The core lab services provide specialised, centralised, and impartial analysis of patient imaging data. This data is an integral part of dossiers for CE, FDA, PMDA, and other regulatory agencies submissions and approvals and serves as valuable information for the medical community. CERC collaborates with medical experts in various specialties to offer core lab services, some of which are listed below:
- Angiographic analysis
- Optical coherence tomography (OCT) analysis
- Echocardiography (Echo) analysis
- Intravascular ultrasound (IVUS) analysis
- Electrocardiogram (ECG) analysis
- Computed tomography (CT) analysis
- Magnetic resonance imaging (MRI) analysis
CERC also has excellent track records in CEC, DSMB, and medical device vigilance services.
Dedicated to Excellence
Dr. Morice was drawn to clinical research from the moment she ventured into interventional cardiology. Over her three-decade career, she has been an integral part of clinical research, resulting in 470 peer-reviewed publications. Her outstanding contributions to cardiology have earned her esteemed recognitions, including Best Clinical Researcher in 1995 (Erasmus) and Cardiologist of the Year in 1997.
Dr. Morice’s visionary contributions to interventional cardiology have greatly improved patient well-being. She is deeply committed to educating and training, particularly young professionals. Some initiatives, such as the PCR Clinical Research program and the PCR Tokyo Valves Course, have supported the next generation of practitioners.
As a board member of the Academic Research Consortium and co-founder of Women as One, Dr. Morice actively works to create a more inclusive, diverse, and equal future for women in medicine. She is also involved in the Stent Save Life initiative and has held various positions in the EAPCI and ESC.
At the inception of CERC, Dr. Morice recognised an opportunity to retire from patient practice and solely focus on clinical research, fulfilling her lifelong commitment to helping people live better. Throughout her career, she has dedicated her life to improving patient outcomes through medical practice or extensive clinical research.
Celebrating a Milestone of Mastery
Reflecting on CERC’s recent 15th-anniversary milestone, Dr. Morice expressed her pride in the team’s accomplishments. She stated, “I am very proud to have worked on clinical research with our team over the past 15 years and with our accomplishments.” Dr. Morice further commended the achievements of the team, founders, and industry partners, highlighting their success in improving patient outcomes through the conduct of critical trials. With more than 8000 peer-reviewed published papers, our research group stands out as one of the most scientifically prolific entities in our field. Our unwavering commitment to advancing clinical practice has significantly contributed to the strengthening of clinical evidence, consequently influencing the development of guidelines and improved patient care.
Dr. Morice, who served as the Senior Consulting Adviser of EuroPCR, has expressed her pride in CERC’s excellent collaboration and contributions to this esteemed organization dedicated to education in interventional cardiology, minimally invasive transcatheter procedures, and related therapies.
Our scientific impact extends to the global stage, with CERC- driven trials taking center stage at world-leading scientific events over the years.
Notably, in the 2023 year alone, nine of our trials have been featured in the Late Breaking Clinical Trials sessions at EuroPCR, TCT, and PCR London Valves, underscoring the significance and impact of our ongoing research initiatives, Dr Morice added.
While acknowledging that there is further work to be done, Dr. Morice highlighted important achievements, stating, “Of course, there is still more work to be done, but I believe that one of our significant accomplishments, in addition to all the trials we are collectively proud of, is that we are part of the ARC Consortium.” ARC is a non-profit organization led by researchers, regulators, and industry partners and is dedicated to unifying trial definitions and designs for comparability and pooling. Dr. Morice believes this to be one of the major achievements.
Continuously Pushing Boundaries in Innovation
CERC is composed of a diverse team of experts, each contributing their unique strengths to ensure the organisation remains at the cutting edge of new developments and technologies. Among them are specialists such as Dr. Mylotte, Dr. Tchetche, and Dr. Garot, who excel in the field of structural heart disease. Dr. Smits, Dr. Hildick-Smith, and Dr Cuisset bring their expertise to coronary artery disease, with Dr. Lassen and Dr. Chieffo mastering bifurcation treatment. Dr. Mehran and Dr. Steg lead in the research of drugs and drug-device combination treatments.
Dr. Paunovic, leveraging extensive experience as the former chief medical officer for Terumo, provides invaluable industry insights and trends while Dr Mori brings the perspectives of scientific societies and governmental organizations. Additionally, physicians like Dr. Capodanno and Dr. Chevalier are adept in clinical trial design and innovation. Dr. Mahfoud’s proficiency in renal denervation and heart failure, alongside Dr. Neylon’s and Dr Erglis, expertise in imaging, further enrich the collective knowledge.
Dr. Morice, sharing an optimistic vision, states, “With many more experts in our CERC family, we are confident in our ability to consistently lead in innovation across all facets of cardiovascular disease, clinical research, regulatory requirements, and industry trends.”
Embracing Diversity in Cardiovascular Research
In Dr. Morice’s words, “At CERC, diversity and inclusion are integral to our team, clinical projects, spanning various types, populations, and geographies. We’re currently driving forward numerous exciting initiatives.” The team takes pride in spearheading a pivotal trial on DeNovo lesions, comparing the efficacy of drug-eluting balloons (DEB) with DES, a topic of immense relevance. Furthermore, they’ve curated specialised TAVI programs designed specifically for women and the Middle East region. Additionally, a substantial randomised trial focusing on Asian populations is underway, evaluating DEB against DES. Dr. Morice emphasises, “Our dedication to diversity and venturing into uncharted territories is mirrored in our collaborations with innovative, up-and-coming firms. We’re grateful for the trust our industry partners place in us.”
CERC’s Future Outlook
Dr. Morice is confident that, with the reinforcement of the management team, the new generation of the clinical research team will be even more efficient and conduct more trials with equally significant impact. Dr Morice shares, “Looking ahead, we acknowledge the challenges posed by European regulations, but I am optimistic that these will soon be addressed, propelling Europe back to the forefront of innovation.”
CERC’s visionary outlook centers on continuous digitalization and the transformative integration of Artificial Intelligence into routine operations, especially in CoreLab but extending beyond. The future direction encompasses broadening therapeutic areas to include neuro interventions, oncology, and pharmaceutical trials. Additionally, CERC aims to support medical device companies in compliance with the Medical Device Regulation (MDR) by implementing lucrative and more efficient trial designs along with real-world clinical evidence.
As such, CERC is poised to lead the way in advancing clinical research by embracing cutting-edge technologies, diversifying therapeutic areas, and navigating regulatory challenges to contribute significantly to the future of medical innovation.
Dr Morice enthusiastically concludes, “The future of innovation and clinical research in Europe will be bright again!”
