How does MEDIACC fit in with service providers (CRO) for clinical studies?

Classification of MEDIACC as a comprehensive service provider of clinical studies for medical devices in Europe

For manufacturers of medical devices who are looking for a contract research organisation (CRO) as part of a clinical evaluation, indication extension, inclusion of a DiGA or DiGA in the BfArM directory, performance study or other "other" clinical investigation, the specialisation for clinical studies of medical devices is relevant. Traditionally and historically, most CROs have specialised in drug trials. Their processes, standard procedures and staff training often do not include the regulatory requirements of Regulation (EU) 2017/745, 2017/746 or ISO14155.

This includes all areas of study conception, design, endpoint selection, study planning and set-up, implementation and data management.

An overview of the tasks and requirements of clinical contract research organisations (CRO), who they benefit and criteria for selection can be found here.

Selecting a contract research organisation (CRO) is a complex process that requires careful planning and consideration and must be aligned with your needs and the clinical investigation required for the innovative product before or after market entry.

‍Challengeus for the best clinical study for the evidence for your innovative medical device.

MEDIACC not only fulfils the typical tasks of a CRO, but also offers additional added value that sets it apart from other providers. Our comprehensive support in conducting clinical studies for medical devices, including regulatory support, data management and quality control, ensures that your projects are conducted to the highest standards - and preferably completely digitally.

‍Whatmakes MEDIACC special?

MEDIACC offers a wide range of services that go beyond the typical functions of a classic CRO. Our services include:

• Clinical studies of medical devices: we support you in planning, conducting and monitoring your clinical studies to ensure they are efficient and successful.
• Regulatory support: Our team will help you with the submission of documents and compliance with all relevant regulatory requirements.
• Data management: We offer comprehensive solutions for managing and analysing your study data to ensure accurate and reliable results.
• Quality management (ISO27001): For digitally conducted clinical studies, the high quality standards formulated in ISO27001 are certified at close intervals and our study processes are optimised through regular audits to ensure the integrity of your studies.
• Creativity: Clinical studies for medical devices are as diverse as medical devices themselves. Finding the right solution for an innovative medical device is part of the study concept.
• Culture and intrinsic values: MEDIACC lives and drives: excellence, innovation, teamwork and close collaboration with our customers, quality and integrity, diversity and sustainability.
• Expertise in fully digital and hybrid study designs: Digital clinical studies, either as decentralised clinical trials or digitally supported hybrid studies with internationally based trial centres, are the established standard of the digital trial centre (DTC-MED®), which enables high-quality studies with large or small numbers of patients to be conducted in a short time without great effort. These designs allow for more efficient data collection and management as well as improved patient participation. Digital studies also offer advantages such as improved data integrity and more efficient processes.
• Over 30 years of experience: Founder and head PD Dr Caroline Schmidt-Lucke has over 30 years of experience from more than 500 clinical studies in various therapeutic areas and medical devices in risk class III.
• LKP: As a physician-led company, we have physicians with many years of clinical experience, so that the study participants are always at the centre, there is a deep understanding of processes in clinics and practices and the tasks of the head of the clinical investigation are taken over from the very beginning. For us, maintaining relationships with the renowned university hospital network is also part of our work. These partnerships give us access to in-depth expertise and support the efficient coordination of complex tasks

‍Our corporate values are not only part of our culture, but also set us apart from other CROs through their consistent implementation. These values guarantee that we offer you customised solutions that are tailored to your specific needs and ensure the highest quality.

Digitalisation and patient centricity: drivers of change for contract research organisations (CRO)

Clinical research is undergoing the same far-reaching transformation process as the other business sectors, albeit with a slight delay. The delay is due to the complex regulatory framework and requirements of"Good Clinical Practice" (GCP) for clinical studies (or clinical investigations, performance studies).

In the area of clinical studies, too, the best solutions in the technological and procedural areas in compliance with GCP and the Declaration of Helsinki will lead to an acceleration of the market entry of innovative products. The increase in efficiency also benefits companies for which it was not possible to conduct clinical studies a few years ago. This also enables smaller companies to utilise such performance for ground-breaking innovations that were previously reserved for large corporations.

MEDIACC attaches great importance to the selection of optimal EDC (Electronic Data Capture) systems for data acquisition in clinical studies, taking into account factors such as GCP, data security, user-friendliness and integration. We work independently of manufacturers and do not allow any compromises in this area.

MEDIACC, as a leading contract research organisation (CRO) for clinical studies of medical devices, relies on innovative technologies and patient-centred approaches to continuously increase the efficiency and quality of clinical studies.

Get in touch with us

If you would like to find out more about our services or need support with your clinical studies, please contact us directly at. Our experienced team is at your disposal to answer your questions and offer you customised solutions.