A structured planning, guidance and monitoring of clinical research projects is essential for their success and quality. By carefully managing projects, risks can be minimized and project goals can be met cost- and time-efficiently.
We support you during the planning, initiation, coordination and monitoring of your projects. Our portfolio encompasses sub-projects as well as entire projects.
Do you need help realizing your clinical studies?
We can help you in all stages of a clinical study (from the initial idea to the official study end).
Our services include:
- Development of a project plan
- Feasibility study
- Financial planning
- Obtaining the approval and favorable opinion of Authorities and Ethics Committees
- Preparation of the necessary study documentation
- Procurement of study personnel
- Coordination of investigator meetings and trainings
- Supervision of the study during the entire term
- Trouble shooting
- Preparation of study reports, congress abstracts, and publications
Do you need support in preparing a clinical evaluation?
We can help you with the following aspects, among others:
- Development of literature search strategies
- Execution of literature searches
- Assessment and summary of literature data
- Preparation/review/revision of clinical evaluations
- Review/revision of clinical evaluation plans (CEP)
We can also help you with implementing the EU regulation 2017/745 (Medical Device Regulation).
Our offers include but are not limited to:
- Assistance in preparing a post market clinical follow-up plan (PMCF plan)
- Review of your documents with regard to the MDR requirements
- Assistance in executing and evaluating the PMCF activities
Furthermore, we can help you with individual tasks:
- Preparation/review of literature search strategies
- Preparation/review/submission of publications
- Review/revision of documents
- Planning of non-interventional studies (NIS)
- Preparation/review of study reports for non-interventional studies