Comprehensive expertise in all phases of clinical trials
Mediconomics has many years of experience in the coordination and execution of clinical studies of phases I-IV in a variety of therapeutic areas. Our multinational team will guide you through the entire study design and conduct process, ensuring that the data collected is of the highest quality.
Cross-phase expertise
With more than 220 completed clinical research projects, we have extensive experience in all phases of clinical trials. Our experts can support you from initial design through to data analysis and reporting, whether it is a Phase I safety and tolerability study or a large multi-center Phase III efficacy study.
Interdisciplinary team of experts
Our multinational team is made up of experienced physicians, scientists, statisticians, project managers and regulatory experts. This diversity of skills enables us to take a holistic view of your project and consider all relevant aspects – from study design to data collection and reporting.
Flexible support according to your needs
Depending on the requirements of the study in question, you can commission Mediconomics to carry out the entire project or just certain areas. We tailor our services to your specific needs and help you choose the best approach for your project.
Compliance with the highest regulatory standards
Clinical research is regulated by numerous national and international regulations. These generally include the AMG (German Medicinal Products Act) and ICH-GCP in the area of medicinal products, as well as the MDR (Medical Device Regulation), the MPDG (Medical Devices Implementation Act) and ISO 14155 for the area of medical devices. We support you in complying with all regulatory requirements, including obtaining the necessary approvals and ethics votes.
Early advice for success
Our specialists work closely with research and development departments and provide advice right from the conception of product ideas. In this way, we ensure that medicinal products and medical devices have the best prospects of obtaining regulatory approval.
Compliance with national and international guidelines
In accordance with national guidelines and the requirements of European and international standards, we advise and support our clients in all phases of the clinical and regulatory life cycle of medicinal products and medical devices. This also includes obtaining the necessary approvals from the relevant ethics committees and higher federal authorities.
Our regulatory expertise
Smooth project management is the key to the success of clinical trials. Mediconomics coordinates all project activities, from participant recruitment to data analysis and reporting. Our experienced team ensures that projects are completed on time, on budget and to the highest quality standards.
Holistic project management
Our experienced project management team will accompany you from the planning to the completion of your clinical trial. We coordinate all activities, including study design, recruitment of trial centers and subjects, data collection and management, and reporting. By providing comprehensive management from a single source, we ensure that all processes run efficiently and smoothly.
Use of the latest technologies
We use state-of-the-art technologies such as electronic data capture systems (EDC) and integrated databases to ensure efficient data management. These enable fast and error-free data collection, plausibility checks in real time and centralized data storage. By automating routine activities, we can save resources and increase data quality.
Compliance with regulatory requirements
Clinical trials are subject to strict regulatory requirements, such as GCP (Good Clinical Practice) and GDPR (General Data Protection Regulation). Our project management team ensures that all processes are carried out in accordance with the applicable regulations. This also includes the preparation of study protocols, test forms and reports in accordance with these requirements.
Flexible support according to your needs
Depending on the requirements of the respective study, you can commission Mediconomics to carry out the entire project or only certain areas. We tailor our services to your specific needs and support you in selecting the optimal approach for your project.
Benefit from Mediconomics’ extensive expertise and infrastructure to successfully implement your clinical research project and advance new therapies. Contact us today to find out more about our services and how we can make your project a success.
Locations
Maps
contact@mediconomics.com
+49 (0) 511 560 998-0
Call us
And what can we do for you?
Dr. (MD) Uwe Albrecht,
FIBMS, FFPM (Dis.), FICR, CSci
CEO
Headquarters
Hanover
FAQ – frequently asked questions
Our experienced project management team coordinates all activities from planning to completion of the study. By using modern technologies and holistic management from a single source, we ensure that projects are completed on time, on budget and to the highest quality standards.
We support you in complying with all applicable national and international regulations when conducting your research project. Our team will obtain the necessary approvals from the relevant ethics committees and higher federal authorities for you.
We prepare regular progress reports, the intervals and scope of which are adapted to the needs of our customers and also project-specific. In this way, we guarantee your ‘sponsor’s oversight’ and keep you up to date on the progress of your project. Necessary decisions can be made in an interactive exchange.
Of course, we also prepare all necessary study reports, such as annual safety reports, interim reports or final reports in accordance with GCP and other regulatory requirements.