CRO for clinical studies in orthopaedics

Our support for your success

Orthopaedics is becoming increasingly important in the modern world. The population is characterized by a high individual urge to move and a constantly increasing life expectancy. This results in problems and injuries that can make every case unique. This is where we can work together and change orthopaedics with your innovative products to provide patients with the help they deserve.

With over 25 years of experience in all areas of clinical research, we have gained valuable experience that we would now like to share with you. We offer you comprehensive support in the planning and implementation of studies tailored to the special needs of patients with orthopaedic diseases. We can also assist you in the recruitment of doctors and patients and in the creation of a study design tailored to you and your product. You can benefit in particular from our expertise with medical devices, innovative technologies and strict regulatory requirements.

Understanding the complexity of orthopaedics and finding solutions

Orthopaedics covers a very diverse spectrum of diseases and their treatment methods. From simple fractures, which can be healed quickly, to congenital malformations or degenerative joint diseases, which usually require lifelong treatment, there are countless challenges to overcome. Each study therefore requires a very precise design that reflects the versatility and complexity of the patient groups concerned. We offer you customized solutions that we will develop in close collaboration with you:

Individual study protocols: We create study protocols that are tailored to the various clinical pictures and treatment approaches. We are in constant communication with you in order to work out the most important endpoints for your product in the best possible way.
Long-term follow-up: Many orthopaedic problems, such as degenerative diseases or traumatic injuries, and their treatment require long-term observation. Our expertise in study design ensures this long-term, continuous and precise collection of patient data over long periods of time.

Patient recruitment and management

The recruitment of suitable test subjects can be a challenge, particularly in orthopaedics, due to age and comorbidity factors. Thanks to our many years of experience in the field of clinical research and the specially developed strategies for patient recruitment, we are very familiar with these challenges and ensure that the patient population is selected to be as representative as possible for your needs.

Analysis of the target population based on the primary criteria and the inclusion criteria
Cooperation with a large number of specialists
Patient education and motivation
Targeted advertising campaigns to reach the desired collective
Educational materials on study objectives and benefits for the subject

Efficient project management

Conducting orthopaedic studies requires a high level of coordination and expertise to adequately respond to any variables and potential risks. Through our experienced project management, we help to ensure that your study is completed efficiently, on time and within budget.

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

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

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 orthopaedics. We offer you:

On-site visits to check that all treatments and patient visits are being carried out correctly
Remote monitoring for prompt review of patient diaries
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 orthopaedic 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 focus on the criteria discussed during study planning (e.g. pain relief, functional improvement or improvement in quality of life), while also taking into account individual adjustments that were necessary or desired during the course of the study. These reports provide you with a sound basis for any planned regulatory applications – which we are also happy to support you with – and also for a successful market launch of your product.

Regulatory support from start to finish

As a team, we support you in all regulatory procedures that you may encounter in the course of your product life cycle – from the initial application to the final approval as a therapeutic option in orthopaedics, we are at your side. We are familiar with the specific regulatory requirements that also affect orthopaedic studies and can therefore take these into account in study planning from the outset. Together, we find suitable endpoints, define safety parameters and take into account potential comorbidities that could limit the success of the therapy, thus ensuring that we successfully overcome regulatory hurdles on 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 orthopaedics. We are aware of the challenges and special features of clinical studies in this field and have already successfully supported numerous projects. Now we would like to bring your project to its goal and change the future of orthopaedics together with you.