CRO for clinical trials in oncology

Comprehensive expertise in oncology

Conducting clinical trials in oncology is a very special challenge, as the treatment of cancer is particularly characterized by the large number of different types of cancer, different stages of the disease and the individual patient situation – no two cases are the same. Thanks to numerous collaborations, we have been able to continuously deepen our experience in the field of oncology and promise you quality and efficiency at all times. We would like to accompany you and your clinical trial – from the first idea you approach us with to the approval of your product.

Together, we start with precise planning of the study and ensure that your clinical study is carried out to a high standard throughout. We also regularly monitor the latest scientific findings and innovative therapeutic methods that could have an impact on your study. With us, you get a customized solution that adapts to your research needs and ultimately brings your products to market faster and more safely.

Individual and customized study designs

Oncological diseases are extremely diverse and studies in this area require customized protocols to meet the different needs of patients. Points that we keep in mind for you at all times include

Diversity of cancer types: From relatively easy-to-treat skin cancer to complex metastatic tumors, each cancer requires specific therapeutic approaches. Therefore, a careful definition of the disease stages to be examined and the target parameters is essential in order to be able to evaluate the effectiveness of the treatment in a uniform manner.
Multimodal treatments: Combination therapies are frequently used in oncology, with a combination of chemotherapy, immunotherapy or targeted radiotherapy often being chosen as the therapeutic approach. We support you in developing a study protocol that takes these different therapy options into account and records the possible interactions.
Personalized medicine: Oncology is increasingly characterized by personalized treatments. Our expertise enables us to develop study protocols that take individual patient profiles into account.

Patient recruitment and management

Recruiting patients for oncology trials can be particularly challenging due to the complexity and variety of treatment options and potential patient cohorts. We use advanced recruitment strategies to efficiently identify and target the right patient population, while always prioritizing the quality of trial outcomes. We also support you with many other challenges:

Recruitment for rare cancers
Increased demands on patient care and the necessary support for test subjects
Long-term follow-up of patients to evaluate optimal efficacy and safety

Endpoint definition and data analysis

Especially in oncology, the precise definition of primary and secondary endpoints is essential for a careful analysis and evaluation of the efficacy of a therapy. Thanks to our expertise, we can reliably take into account a wide range of different parameters to advance your project individually:

Clinical endpoints taking into account the latest findings from molecular oncology such as biomarkers
Subjective endpoints through various tools for recording quality of life
Complex data analysis with advanced technologies to provide you with the most accurate study results possible

Patient welfare and ethical responsibility

In oncology, the well-being of patients always comes first and we are fully aware of the responsibility this entails. Thanks to our experience, we can support you in keeping patient safety at the highest level at all times.

Patient education, which we customize specifically for your study to prepare patients, physicians and family members for any possible scenario and encourage cooperation
Long-term care to ensure that patients receive the best possible care at all times

Efficient project 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

Through our high-quality monitoring, we ensure the quality and integrity of the data collected in your studies, paying particular attention to the challenges within oncology. 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
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 oncology 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. In doing so, we prepare the complex amount of data consisting of imaging, genome data and patient surveys for you and also take into account individual adjustments that were necessary or desired during the course of the study. With these reports, we provide you with 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 therapy.

Regulatory support from start to finish

Oncology studies are subject to strict regulatory requirements. As a team, we support you in all regulatory procedures that you may encounter in connection with an oncological therapy approach – from the initial application to the final approval as a therapy option in oncology, we are at your side. We are familiar with the specific regulatory requirements that particularly affect oncology studies and can therefore take these into account from the outset of study planning. We also support you in minimizing regulatory costs by helping you to obtain orphan drug designation or SMB (small medium business) status.

Together, we find suitable endpoints, define safety parameters and take into account the different types and stages of cancer whose multimodal treatment could influence the success of the therapy, 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 oncology. We are aware of the challenges and special features of clinical trials in this field and have already successfully supported numerous projects. You too can rely on our experience and expertise to successfully implement your oncology study and let us contribute to the development of innovative cancer therapies together.