CONCEPTION - CUSTOMIZED SOLUTIONS FOR YOUR CLINICAL TRIAL

Sophisticated study designs for patient-centered solutions

Work with us to design a well thought-out study and project concept based on the needs and requirements of affected individuals and relevant service providers.

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Strategy development
Concept
Planning & Preparation
Study implementation
Closing and utilization of results
INDIVIDUAL STUDY CONCEPTS FOR INNOVATIVE HEALTH SOLUTIONS

A well thought-out concept for your success

Join us for a deeper dive into project design. Our overarching goal is to improve care for affected individuals, and a physician- and patient-centered mindset is integral to this goal. Patient perspectives and preferences, as well as the needs and experiences of affected individuals, take a central role in study design. From the outset, we also involve expert colleagues so that you can address their needs more quickly and accurately and benefit from their expertise.

COMPREHENSIVE PROJECT DEVELOPMENT

Define your study goals and requirements

In our first joint concept meeting, we develop a solid understanding of your study goals and requirements. Together we evaluate which type of study implementation is best suited for your project and which digital elements are needed.

  • Outline of the study and project concept
  • Determining the appropriate study implementation: decentralized or centralized
  • Identification of required digital elements
  • Preparation of an initial project management plan
  • Discussion of budget and resource issues

This first step is critical to developing a shared understanding of your study and paving the way for successful collaboration throughout the design process.

Evidence generation experts

Systematic literature review and thorough data evaluation
We are experts in generating evidence: In order to identify suitable methods and instruments, we may carry out a thorough systematic literature review. Have you already generated initial application or user data for your product? We would be happy to design an initial data evaluation. This may make it possible to avoid a complex clinical trial.

Integration of digital elements

From the outset, our approach takes into account the potential for digitization and cost savings in your study. We advise you on the requirements for an electronic data collection system and other digital elements such as electronic signatures or medical video consultations. Benefit from our extensive network of qualified market-leading providers and our expertise in interface coordination.

Keep flexibility

Decide on the basis of a responsibility matrix which processes or sub-processes will be taken over by us or our partners or even by yourself - this way you keep flexibility in budget calculation and we can develop a project management plan for efficient study planning and execution.

Ensuring compliance

Compliance with international and national regulations
We ensure that all processes comply with international (ISO 14155, ICH-GCP, MDR, IVDR, DSGVO) and national regulations (BÄO, BMV-Ä, MPDG). The data of your study participants are protected by our certified information management system (ISO 27001).

From evidence to market-wide acceptance

Over 30 years of experience in study design

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.

Contact us today for a personalized 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.

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