Conceptualisation - CUSTOMIZED SOLUTIONS FOR YOUR CLINICAL TRIAL

Advanced trial designs for patient-driven solutions

Partner with us to to create a meticulously planned study and project strategy that addresses the needs of affected individuals and key healthcare stakeholders.

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

A carefully considered framework ensures your success

Delve deeper into project conceptualisation with us. Our overarching aim is to enhance care for those affected, and a physician- and patient-centric mindset is integral to this goal. Patients' perspectives and preferences, as well as the needs and experiences of those affected, play a central role in clinical trial design. From the outset, we involve specialist colleagues to ensure you can swiftly and precisely address their requirements and benefit from their expertise.

COMPREHENSIVE PROJECT DEVELOPMENT

Define your research objectives and specifications

During our initial joint conceptualisation meeting, we will develop a robust understanding of your research objectives and requirements. Together, we will evaluate which type of clinical trial implementation is best suited for your project and determine which digital elements are appropriate.

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

This first step is critical to developing a shared understanding of your clinical trial and paves the way for successful collaboration throughout the more detailed design process.

Experts in evidence generation

Systematic literature review and thorough data evaluation
As specialists in evidence generation, we perform a meticulous systematic literature review when required to identify appropriate methodologies and tools. If you have already collected initial application or user data for your product, we can carry out a preliminary data evaluation. This process may potentially eliminate the need for an extensive clinical study and therefore reduce costs.

Integration of digital elements

Our approach considers the potential for digitalisation and cost reductions in your clinical trial from the outset. We provide guidance on the requirements for an electronic data capture system and other digital elements such as verified electronic signatures or virtual medical consultations. Benefit from our extensive network of qualified market-leading providers and our expertise in interface coordination.

Maintain flexibility

Utilise a responsibility assignment matrix to decide which processes or sub-processes will be managed by us, our partners, or your in-house team. This method preserves your budgetary flexibility and enables us to create a project management plan for the effective planning and implementation of your study.

Ensuring regulatory compliance

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

From evidence to market-wide acceptance

Over 30 years of experience in clinical trial design


Leveraging our long-standing experience in clinical trial design, we provide effective and tailored strategies for your products. With our support, you can rest assured that valuable time will not be squandered in crafting a suitable project strategy.

By collaborating on strategy development, we establish a solid foundation for the success of your clinical trial. Our objective is to assist you at every stage of developing your health innovation, striving for optimal results.

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.

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