Leveraging our experience and expertise, we ensure efficient planning and preparation for your clinical trial. Partnering with us will guarantee all crucial steps for a successful clinical trial are meticulously executed.
Leveraging our experience and expertise, we ensure efficient planning and preparation for your clinical trial. Partnering with us will guarantee all crucial steps for a successful clinical trial are meticulously executed.
Based on the clinical trial protocol, we develop additional essential trial documents (including statistical analysis plan with sample size estimation, data protection concept, patient information and informed consent form, data processing register) for submission to the competent authority (e.g., BfArM) and ethics committee.
Securing the ideal research collaborators is crucial for your trial's success. Our long-standing expertise in diverse therapeutic areas allows us to leverage a far-reaching network of appropriate study sites and key opinion leaders, ensuring timely recruitment of suitable participants for your research. We offer support in identifying and engaging suitable partners, while handling the intricate contract management process.
To address the increasing resource shortage in clinical trial centres, we can engage additional medical study personnel to provide on-site relief.
Our team is on hand to help you prepare for discussions with regulatory auhorities or to handle further correspondence throughout your trials's execution. We offer support with application processes, consultative sessions with appropriate authorities, and trial registration protocols.
Leveraging our experience and expertise, we ensure efficient planning and preparation for your clinical trial. Partnering with us will guarantee all crucial steps for a successful clinical trial are meticulously executed.
We create, verify, and validate a study platform tailored to your trial's requirements. To this end, we conduct a standardised, documented system validation process and a logged testing procedure to ensure critical system functions.
After the successful test phase, we conduct a trial run with independent individuals to identify and eliminate possible sources of errors before the clinical trial platform is released.
Our experienced professionals are on hand throughout the entire planning and setup stage, and remain by your side during later phases of study conduct. This approach ensures your research aligns with current regulations and unfolds seamlessly.
Our established monitoring, quality assurance and data management concept ensures that your study complies with current guidelines and is of high quality. Our experienced team, with an average of more than 10 years of experience, accompanies you in this process.
Our many years of experience in study design enable us to offer you effective and customized strategies for your products. With us at your side, you can be sure not to lose valuable time in developing a suitable project strategy.
By collaborating on strategy development, we lay the foundation for the success of your trial. Our goal is to support you every step of the way in developing your medical devices or digital health applications to achieve the best possible results.
From data preparation to statistical analysis - our experienced team of scientists and analysts will support you in your next research project. Trust in our expertise and let us find the answers you are looking for together.