CRO for clinical studies in dermatology

Our solutions for clinical studies in dermatology

Dermatology presents unique challenges that researchers, developers and medical professionals are confronted with on a daily basis. Skin diseases in particular are a heavy burden for those affected – both physically and mentally – as there are usually visible symptoms. For these very reasons, careful and continuous research in the field of dermatology is essential. As an experienced CRO, we would like to support your research project and offer you support for your clinical study:

Customized project planning
Data analysis with an eye for detail
Highest quality standards

Thanks to our many years of experience in the field of dermatology, we can guarantee that we will accompany your products in the most uncomplicated and effective way possible on the path from initial clinical trials to market approval. We will support you with the initial administrative procedures and ensure that patients are continuously recruited for your ongoing studies in order to bring them to a conclusion as quickly as possible.

Customized solutions

Due to the unique challenges mentioned above, it is necessary to approach each study as individually as those affected by dermatological diseases deserve. With us, you will find a partner who pays attention to every detail of study planning, which is ensured by close cooperation between all departments. We offer you:

Individual study protocols: We create study protocols that are tailored to the various clinical pictures and treatment approaches. We will work closely with you to identify the most important endpoints for your product in the best possible way.
Selection of suitable study parameters: An individualized study protocol naturally also requires that any study parameters are equally adapted to each situation. We work out the most suitable endpoints, such as improvement in skin appearance, reduction in itching or healing rates, and take into account seasonal influences that can affect certain clinical pictures (season, humidity, UV index)

Patient recruitment and management

Through our years of experience in clinical research and the patient recruitment strategies we have developed, we are very familiar with the challenges of recruitment and have always supported trial centers in ensuring that the patient population is selected to be as representative as possible for the respective issue. Our techniques include:

Analysis of the target population based on the selected inclusion criteria such as skin type or disease progression
Cooperation with selected dermatologists and specialized clinics
Continuous patient education and motivation
Targeted advertising campaigns via dermatology portals and social media
Educational materials on study objectives and benefits for the subject

Efficient project management

Conducting dermatology studies requires a high level of coordination and expertise to adequately respond to any variables and potential risks. Through our experienced project management team, we help to ensure that your study is completed efficiently, on time and within budget. Seamless integration of all parts of the project is particularly important to us and we offer:

Interface for transparent communication between all parties involved
Flexible resource management, adapted to your requirements
Use of state-of-the-art technologies to record and analyze the study parameters
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. We guarantee this:

State-of-the-art technology
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 dermatology. We offer you:

On-site visits to check that all treatments and patient visits are being carried out correctly
Remote monitoring for prompt checking of patient diaries, for example
Central monitoring to identify trends and respond to them immediately
Training for investigators to ensure objective assessment of dermatological symptoms in all trial centers

Clear and precise reporting

At the end of your dermatology study, we provide you with a thorough and transparent evaluation of the data collected. We prepare meaningful study reports for you in a timely manner, focusing on the key clinical findings. We focus on the criteria discussed during study planning (e.g. improvement in skin appearance, reduction in itching or quality of life), while also taking 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 further planned regulatory applications – for which we are also happy to support you – 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 an application option in dermatology, you can count on us. We are familiar with the specific regulatory requirements that also affect dermatology 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 seasonal influences that could reduce the success of the therapy, thus ensuring that we successfully overcome regulatory hurdles on the first trial. We support you in communicating with the authorities and prepare you optimally for any remaining 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 dermatology. 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 dermatology together with you.