CRO for clinical studies in urology

Our support for your success

Like many other areas of medicine, urology is an extremely diverse field with a multitude of clinical pictures and symptoms, such as functional or structural urinary tract disorders or disorders of the male reproductive organs. As individual as each patient is, research in this field must also be conducted on an individual basis. We are well aware of this difficulty and have therefore been able to gain a very broad range of specialist knowledge through the supervision of various clinical studies in this specialist area, which we would now like to use to support you and your project.

With our 25 years of experience in conducting clinical trials, we are the ideal partner for your urological concerns. We are familiar with special patient populations, difficult regulatory applications and complex data sets and are therefore guaranteed to provide you with satisfactory support from the initial application to the final evaluation of your study. With a customized study design and our knowledge of patient recruitment and data analysis, we will be happy to convince you and bring your product smoothly through to approval.

Customized solutions

Urological studies always deal with very sensitive topics that the majority of the population is reluctant to think about, let alone talk about. It is therefore all the more important to make a contribution to research here. And optimal research requires a study protocol that is specifically tailored to it. We are aware that the success of a study depends to a large extent on the design of the protocol. For this reason, 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 individual study protocol naturally also requires that any study parameters are also adapted to each situation. We specifically select endpoints such as symptom burden, functionality and quality of life to give your product the necessary resilience for approval. We also take into account potential influencing factors such as age, concomitant diseases and previous drug treatments when drawing up the protocol, thus avoiding surprises during the evaluation.

Patient recruitment and management

Through our years of experience in the field of clinical research and the specially developed strategies for patient recruitment, we are very familiar with the challenges of recruitment and have always successfully supported the trial centers in selecting the best possible representative patient population for the respective issue. Our techniques include:

Analysis of the target population based on the selected inclusion criteria
Cooperation with selected urologists and specialized clinics
Continuous patient education and motivation
Targeted advertising campaigns via specialist medical portals and social media
Use of patient registries for chronic urological diseases

Efficient project management

Conducting clinical trials requires a high level of coordination and expertise at all times in order 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:

An 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 urology. 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 guarantee a standardized evaluation of urological parameters in all trial sites

Clear and precise reporting

At the end of your urological study, we provide you with a thorough and transparent evaluation of the collected data. We prepare meaningful study reports for you in a timely manner, focusing on the key clinical findings. The criteria discussed during study planning (e.g. quality of life, pain or incontinence) are in the foreground, whereby we 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 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 a product within urology, you can count on us. We are familiar with the specific regulatory requirements that also affect urological studies and can therefore take these into account in study planning right from the start. Together, we find suitable endpoints, define safety parameters and take into account potential influences that could reduce 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 any remaining queries. We want to make the approval process for your product 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 urology. 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 together with you and change the future of urological treatment.