CRO for clinical studies in dentistry

Comprehensive expertise in dentistry

Dentistry is a very complex challenge for many clients due to the variety of treatment approaches and the often individual needs of patients. With technology advancing at an ever-increasing pace and improved treatment options in the field of dentistry, continuous research is essential to provide patients with new and improved therapies. We want to help you transform the conduct of clinical trials within dentistry from a challenge to an ease for you.

We can help you conduct clinical trials with the highest precision so that they meet the highest scientific standards. Let us be part of your journey – from the initial planning to the market launch of your new innovative therapies and products!

Tailor-made study design - diverse treatment approaches and individual patient needs

There is a wide range of treatment approaches in dentistry. These range from preventive measures to complex surgical procedures. The diversity of dental treatments means that we need to design a study protocol that is as customized as possible to your specific requirements. Thanks to our many years of experience in a wide range of specialist areas, we are ideally prepared for this task and are able to respond to all your needs in the best possible way:

Selection of suitable inclusion and exclusion criteria
Conservative vs. surgical treatments and associated safety and efficacy requirements
Selection of suitable treatment periods and subsequent follow-up periods
Consideration of different patient needs and characteristics such as oral hygiene, genetic predisposition and existing diseases such as periodontitis

Patient recruitment and management

Although the recruitment of suitable patients in dentistry is comparatively unproblematic compared to other medical disciplines due to the wide range of treatments offered by dentists and the often quite short treatment times, there are still some challenges that need to be overcome. You can always rely on our expertise to meet these challenges.

Recruitment of specific patient groups: Recruitment is often difficult, especially in specialized studies in which a very narrow patient group (e.g. patients with tooth loss or periodontitis) is sought.
Long-term studies: dental treatments such as the insertion of implants or orthodontic therapies require long-term follow-up in order to evaluate the success of the therapy. Together we develop a suitable study concept to maintain patient loyalty over long periods of time.

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

Precise 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. Just as dentistry is constantly evolving and using the latest technologies, we also offer you the same in data processing:

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 dentistry. 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 and precise reporting

At the end of your dental 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 prepare the complex data, consisting of multidimensional endpoints for recording the success of treatment and long-term observations in the case of serious interventions, according to your wishes and, of course, also take into account individual adjustments that were necessary or desired during 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 a successful approval of your therapeutic approach.

Regulatory support from start to finish

Clinical studies in dentistry are subject to strict regulatory requirements, just like all other studies. 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 medicinal products and medical devices and can therefore take these into account in study planning from the outset.

Together, we find suitable endpoints, define safety parameters and also take into account the different regulatory standards and requirements that dental products are subject to in different countries, 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 dentistry. 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.