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Catalogue of Services

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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Study design - solutions for your clinical evidence

Sophisticated trial designs for patient-centered solutions

MEDIACC provides you with study concepts that are customised to your medical product and precisely tailored to your regulatory requirements and corporate objectives. We create study concepts for you that are scientifically sound, efficiently feasible and optimised for the regulated healthcare market.
Work with us to design a well thought-out study and project concept that is based on the needs and requirements of those affected and relevant service providers.

Arrange a workshop now

Steps in designing a clinical trial for medical devices

Designing a clinical investigation (trial) for medical devices requires a structured, transparent and closely coordinated process with you as Manufacturer. MEDIACC accompanies you from initial goal definition to operational preparation and ensures that all regulatory, scientific and practical requirements are optimally met.

  • Goal definition and requirement analysis
  • Systematic literature review and data evaluation
  • Development of the trial concept and selection of trial design and trial type
  • Involving relevant stakeholders
  • Planning and preparation of study documents
  • Ensuring regulatory compliance (MDR, ISO 14155, GCP, GDPR, other national and international requirements)
  • Budget and resource planning
  • Project management and time planning
  • Preparation for implementation (training, logistics, monitoring)
  • Continuous quality and risk management
  • Continuous agreements to ensure success
From evidence to market-wide acceptance

Over 35 years of experience in trial design

Studies for your medical device can and must be designed differently than in the pharmaceutical sector.

Our many years of experience in study design enable us to offer you effective and tailor-made strategies for your products. The concept is an iterative process in which our specialists with many years of practical experience focus on every detail while keeping the big picture in focus.

This is where we lay the foundation for the success of your study. Our goal is to support you at every step of the development of your medical devices and achieve the best possible results.

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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
Our services
Strategy developmentStudy conceptImplementation / Clinical PhaseConclusion and utilization of resultsDDCT-MED®
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