Scoping & Clinical Project Preparation - Clinical, operational, and regulatory project preparation with Charité
Service Description
CEED supports startups, SMEs and healthcare technology companies in the structured preparation of clinical, operational and regulatory projects within the Charité ecosystem.
The service focuses on creating a structured foundation for subsequent clinical project implementation, including:
- project scoping,
- documentation review,
- stakeholder alignment,
- clinical and regulatory assessment,
- and project and cost planning.
The service addresses common early-stage challenges such as:
- unclear clinical project scope,
- regulatory and evidence uncertainty,
- identification of suitable Charité stakeholders,
- and limited transparency regarding feasibility, timelines and costs.
Activities include:
- review of product, project and scientific documentation,
- identification and initial engagement of relevant Charité stakeholders,
- initial assessment of clinical, operational and regulatory project requirements,
- development of project roadmaps,
- and preliminary cost and implementation planning.
Depending on project maturity and requirements, the service may include integration with:
- clinical departments,
- institute of medical informatics,
- data and research infrastructure,
- regulatory and ethics interfaces,
- and operational study support structures.
The service is designed to establish a structured basis for future clinical validation, PMCF, real-world data or implementation projects within complex hospital environments.
Provider & Contact
Fixed-price scoping and preparation module for early-stage clinical, operational and regulatory project alignment within the Charité ecosystem. Additional services may be integrated depending on project progression and requirements.