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From Strategic Consultancy to the Planning and Execution of Clinical Trials

Strategieentwicklung und Beratung

Workshops für individuelle Studienlösungen und Unsicherheitsbeseitigung.

Study design

Creation of study concepts and consulting on digital study elements.

Performance of Clinical Studies

Training, study monitoring and close collaboration with study centers.

DDCT-MED®

Digital Decentralised Clinical Trials in the MEDIACC

Biomedical Statistics and Clinical Outcome Evaluation

From initial data to convincing results for your medical device

Publications and Medical Writing

Data analysis, study reports, and support for professional publications.

Trainings and Seminars

Practical knowledge transfer for your success

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StrategIC development for YOUR clinical trial

The cornerstone for your successful health innovation

Strategic development is the first step in ensuring the success of your medical device or digital health application. Utilise our market knowledge to establish the appropriate evidence base for your product and let us collaboratively develop bespoke solutions in a workshop setting.

Arrange a workshop now

MEDIACC services within the framework of Digital Decentralised Clinical Trials (DDCT-MED®) include:

Consulting, conception and planning of formally multicentre decentralised digital studies or integration of individual elements (hybrid), manufacturer-independent:

  • Advice and support in the complex selection process
  • Preparation of the test plan with all attachments
  • Preparation of all required trial documents and processes
  • Setting up completely digital trial concepts and discussing them with ethics committees and authorities
  • Development and implementation of digital recruitment strategies
  • Electronic consent processes
  • Using digital platforms for data collection, patient communication and study management
  • Conducting and managing fully digital or hybrid clinical trials
  • Remote monitoring and digital data management
  • Training and support for study staff and patients in using digital tools
  • Close cooperation and support of study centres, including international centres
  • Integration of telemedicine and telemonitoring into study processes
  • Ensuring data protection and IT security in accordance with regulatory requirements
  • Support for the integration of mobile sensors and apps for objectifying data collection
  • Central, certified Digital Trial Centre (DTC-MED®) with qualified study assistants and physicians
  • Evaluation and reporting based on digitally collected study data
  • Control of recruitment speed and target population in real time
  • Evidence-based increase in retention rate through automated and haptic motivational elements
  • Monitoring (central/digital in real time)
  • Data evaluation, preparation of study reports and support for scientific publications

Technical and Process Description of Digital Clinical Trials for Medical Devices

We provide evidence from clinical trials based on GCP-compliant, manufacturer-independent digital, decentralised, or site-based clinical investigations (trials for medical devices). Our services cover all phases of clinical trials—study planning, conduct, and analysis—and are seamlessly integrated with our Digital Trials Manager, a technology specialized in digital studies.

Within the framework of hybrid or fully digital studies, MEDIACC offers the use of a dedicated study platform. This platform enables electronic collection, management, and processing of clinical trial data. For those wishing to leverage the advantages of digitally managed studies, MEDIACC recommends study management via a study platform—even when site-based study centres are involved. Of course, it is still possible to conduct a traditional, predominantly paper-based study; however, based on our extensive experience and scientific evaluations, we believe the benefits of a study platform are clear—particularly in terms of significantly reduced personnel requirements for data collection, as well as improved data quality and plausibility.

MEDIACC is your partner for elegant, efficient clinical trials for your medical device—working with you and for your patients. We rise to your challenges and support your product with individual or comprehensive consulting and services for both traditional and fully digital clinical trials (DDCT-MED®), all from a single source. With our digital trial centre (DTC-MED®), you have access to a highly specialised team ranging from study assistants and investigators to principal investigators. Our experts are deeply familiar with the regulatory landscape of European and national evidence generation, as well as the practical challenges of clinical trials, and understand your business objectives.

For further, detailed information on the technical and procedural aspects of DDCT-MED® and DTC-MED®, please contact us during the conceptualization phase of your hybrid or fully digital clinical study.

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Similarities and Differences Between Traditionally and Digitally Conducted Clinical Trials

Despite all their differences, traditionally and digitally conducted clinical trials share fundamental principles and requirements. Both are based on the same scientific, ethical, and regulatory standards. The primary goal remains the valid, safe, and transparent generation of clinical evidence.

The key differences between traditional and digital clinical trials include:

  • Type of data collection (paper-based vs. electronic)
  • Recruitment speed and reach
  • Flexibility and burden for patients (on-site visits vs. digital participation)
  • Monitoring (manual/on-site vs. centralised/digital in real time)
  • Resource consumption (paper, travel)
  • Cost structure and planning reliability
  • Possibility for real-time management and adaptation

Digital clinical trials differ from traditional approaches through faster recruitment, higher efficiency, better data quality, greater patient centricity, increased sustainability, and reduced resource consumption. They enable efficient, flexible, and regulatory-compliant conduct of clinical investigations—a clear advantage for manufacturers and patients alike. The degree of digitalisation should be chosen based on various factors relevant to each individual study.

Regulatory Assurance for Your Digital Study

DDCT-MED® complies with all relevant regulatory requirements:

  • We follow the guidelines of the ACT EU Initiative and the European Medicines Agency (EMA).
  • We take into account the "Recommendation Paper on Decentralised Elements in Clinical Trials" (2022).
  • We implement the "Guideline on Computerised Systems and Electronic Data in Clinical Trials" (2023).
  • We meet the requirements of the FDA for decentralised clinical trials.
  • Data protection in accordance with GDPR and the highest level of IT security according to ISO 27001.
Focus on medical devices

Why choose MEDIACC to conduct clinical trials?

MEDIACC stands for transformative patient-centered clinical studies at the highest scientific level in Germany and Europe and is recognised as an independent scientific institute by Authorities and international standards organisations. In doing so, we are guided by your company and product-specific needs.

Traditional and digital clinical trials differ primarily in their implementation, but are based on the same scientific, ethical and regulatory principles. The aim always remains the valid, reliable and verifiable generation of clinical evidence.

Our digital processes optimise study implementation and increase data quality. We use cutting-edge technologies that simultaneously meet regulatory requirements: Our risk management and continuous monitoring ensure the highest quality and data integrity for your study.

From designing traditional or completely digital clinical trials to reports or high-level publications, from initial data analyses to complex research issues — challenge us!

Contact us today for a personalised consultation!

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.

Arrange a free consultation now
address:
Sächsische Strasse 70
10707 Berlin Wilmersdorf
Germany


contact:
030 521 044 80
info (at) mediacc.de
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