CRO for clinical studies in cardiology

Our range of services for your success

Clinical studies in cardiology pose unique challenges due to the complexity of cardiovascular diseases and the wide range complicated treatment options. As cardiovascular conditions remain a leading global health concern, research in this field is essential for advancing both prevention and therapy.

We offer comprehensive support and expertise in this field to help you efficiently design and conduct clinical trials in cardiology -whether for pharmaceuticals, medical devices, or innovative treatment approaches. Through customized study designs, efficient patient recruitment and focused study management, we help bring your products to market faster and more reliably. Our modern state-of-the-art data management is precise and and provides fast, professional reporting to meet all regulatory requirements on the path to approval.

Whether you are developing new drugs to treat high blood pressure or a medical device for international cardiology, we’re the partner you can trust to support you every step of the way.

Tailor-made study design - complexity of cardiovascular diseases

Cardiology encompasses a broad range of diseases, all of which have an individual etiology, manifestation and treatment, making a tailored study design essential. When developing a study protocol, we therefore address a variety of challenges in order to provide you with the best possible support:

Definition of exact and suitable inclusion and exclusion criteria
Consideration of comorbidities, as cardiology patients often present with multiple concurrent conditions
Selection of relevant endpoints such as quality of life factors, blood pressure or various biomarkers
Determination of suitable treatment periods and possible follow-up phases

Patient recruitment and management

The recruitment of patients for cardiology studies requires a highly targeted approach, as subgroups (e.g. certain disease stages) are often required. Our experienced team used an extensive repertoire of methods to identify and engage suitable patients for your study:

Analysis of the target population based on the inclusion criteria
Selection of suitable ans close cooperation with specialists
Targeted advertising campaigns to effectively reach the right audience
Adaptation of the study design to optimize patient retention in long-term studies
Educational materials on study objectives and potential benefits for subjects

Efficient project management

Our experienced project management team can help to ensure that your study is completed efficiently, on time and within budget. Acting as your central point of contact, our project managers oversee and coordinate all aspects of the trial, from planning and logistics to communication with all involved parties. We guarantee you:

Structured planning and implementation of the study
Interface for transparent communication between all parties involved
Flexible resource management, adapted to your requirements
Fast response to unforeseen events and continuous quality assurance

Clinical data management

Our data management team is always on hand to help you collect comprehensive data sets and ensure that all parameters are accurately recorded and thoroughly analysed. Working in close collaboration with you, we provide prompt access to collected data and thus enable efficient evaluation. As examination methods continue to evolve, so too does the quality and scope of the data we gather. We remain committed to applying the latest state-of-the-art data processing techniques, with particular attention to:

State-of-the-art technologies
Rigorous control and professional handling of all collected data
Precise evaluation of data for interim reports
Close cooperation with monitoring for the best data integrity

Clinical monitoring

Our high-quality monitoring processes safeguard the quality and integrity of the data collected in your studies, paying particular attention to the unique challenges within cardiology. We offer you:

On-site visits to confirm the correct implementation of all treatments and patient visits, as well as patient safety
Remote monitoring for timely review of patient diaries in long-term studies
Central monitoring to identify trends and issue appropriate and immediate responses
Training for investigators to guarantee a standardised procedure in all trial centres

Clear reporting

At the conclusion of your cardiology study, we provide you with a comprehensive and transparent evaluation of the data collected. Our team quickly prepares meaningful study reports for you, summarising the relevant clinical findings. We provide you with an overview of the full data, including the predetermined multidimensional endpoints that illustrate the efficacy of the therapy and long-term observations of serious interventions. Any individual adjustments made during the study are fully reflected. These detailed reports provide a solid foundation for any planned further regulatory applications – which we are also happy to support- and also contribute to the successful approval of your therapeutic approach.

Regulatory support from start to finish

Clinical trials in cardiology are subject to particularly strict regulatory requirements. As a team, we can support you in all regulatory procedures- whether for medicinal products or medical devices, by bringing in-depth expertise to help your projects succeed. With a thorough understanding of the specific regulatory governing both product types, we incorporate all relevant requirements in study planning right from the outset.

Together, we identify suitable endpoints, define safety parameters and also ensure alignment with the regulatory standards and requirements to which cardiology products in particular are subject. This proactive approach ensures that we efficiently and successfully overcome regulatory hurdles. We also support you in communicating with the appropriate authorities and prepare you optimally for any potential follow-up queries. Our goal is to make the approval process for your therapeutic approach as efficient as possible and by identifying, addressing and avoiding potential obstacles at an early stage.

Place your trust in our expertise

Benefit from our specialised experience in the field of cardiology. We have successfully supported numerous projects and would be delighted to support you and with yours. Rely on our experience and experience to successfully implement your clinical study, and let’s work together to advance innovative therapeutic approaches.