CRO for clinical studies in cardiology

Our range of services for your success

Clinical studies in cardiology pose a particular challenge due to the complexity of cardiovascular diseases and the large number of very complicated treatment options. When it comes to the development of new drugs, medical devices or innovative treatment methods, research in cardiology is of crucial importance for progress in the cure and treatment of cardiovascular diseases.

We offer you our comprehensive support and expertise in this field to help you efficiently design clinical trials in the field of cardiology and thereby make a contribution to medicine. With our customized study designs, efficient patient recruitment and our study management with an eye for the essentials, together we will bring your products to market faster and more reliably. Our modern data management is precise 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 interventional cardiology, we are the right partner for you.

Tailor-made study design - complexity of cardiovascular diseases

Cardiology encompasses a variety of diseases, all of which have an individual etiology, manifestation and treatment, which makes an equally individual study design necessary. When drawing up a study protocol, we therefore tackle a variety of problems 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 suffer from several diseases at the same time
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 precise selection, as subgroups (e.g. certain disease stages) are often required. Our experienced team has an extensive repertoire of methods at its disposal to effectively find suitable patients for your study:

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

Efficient project management

With our experienced project management, we help you to ensure that your study is completed efficiently, on time and within budget. Our project managers coordinate all aspects of the study centrally and act as a central point of contact across the board. 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 subsequently analyzed. In close cooperation, we provide you with the collected data promptly and thus enable efficient evaluation. Despite constant further development of the examination methods and thus also of the collected data, we always offer you the latest state of the art in data processing and pay 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 ensures the quality and integrity of the data collected in your studies, paying particular attention to the challenges within cardiology. We offer you:

On-site visits to check the correct implementation of all treatments and patient visits, as well as patient safety
Remote monitoring for prompt review of patient diaries in long-term studies
Central monitoring to identify trends and respond to them immediately
Training for investigators to guarantee a standardized procedure in all trial centers

Clear reporting

At the end of your cardiology study, we provide you with a thorough and transparent evaluation of the data collected. We prepare meaningful study reports for you as quickly as possible, summarizing the relevant clinical findings. We provide you with the complex data, consisting of multidimensional endpoints to record the success of the therapy and long-term observations of serious interventions, according to your wishes and, of course, also take into account individual adjustments that were necessary or desired in the course of the study. With these reports, we offer you a sound basis for any planned further regulatory applications – in which we are also happy to support you – and also for 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 support you in all regulatory procedures that you may encounter here – both in the field of medicinal products and medical devices, we contribute our expertise and help your projects to succeed. We are very familiar with the specific regulatory requirements for both medicinal products and medical devices and can therefore take these into account in study planning right from the start.

Together, we find suitable endpoints, define safety parameters and also take into account the regulatory standards and requirements to which cardiology products in particular are subject, thus ensuring that we successfully overcome regulatory hurdles at the first attempt. We support you in communicating with the authorities and prepare you optimally for the remaining possible queries. We want to make the approval process for your therapeutic approach as efficient as possible and identify, address and avoid potential obstacles at an early stage.

Place your trust in our expertise

Benefit from our specialized experience in the field of cardiology. We have already successfully supported numerous projects and would be delighted to support you and your project. You too can rely on our experience and expertise to successfully implement your clinical study and let us contribute to the development of innovative therapeutic approaches together.