Study set-up
As a consultancy company, we are aware that our Clients may require support in selected aspects of clinical trials, which are known to be complex and multi-stage. This is why we offer flexible, customized solutions in terms of assistance in study set-up, designed to fit the purpose of our Clients. We offer assistance in the design and planning of the clinical trial, whether it is Phase I (including First in Human, FIH), or Phase IV or observational study.
The study set-up that we provide include:
- Support in the planning of the clinical trial assumptions, including the choice of endpoints, hypotheses assumptions and estimation of sample size necessary to achieve sufficient power of the study,
- Analysis and recommendations regarding the preparation of a Paediatric Investigation Plan (PIP), or its waiver. Preparation of relevant documentation,
- Preparation or verification of clinical trial application and essential study documents including (but not limited to):
- Study Protocol,
- Investigator’s Brochure (IB),
- Subject Information Form and Informed Consent Form (ICF),
- Case Report Form (CRF),
- Preparation or verification of Investigational Medicinal Product Dossier (IMPD, also for ATMPs),
- Search and selection of clinical sites, feasibility and (if necessary) site selection visits together with recommendation on desirable site,
- Submission of the CTA to the appropriate Competent Authority and Bioethics Committee (regarding clinical trials of medical devices), or via the online clinical trial information system (CTIS), to the competent competent authority and the Bioethics Committee (regarding clinical trials of medical devices) or via the clinical trials information system (CTIS) in the case of clinical trials of medicinal products,
- Communication with experts from the Agency allowing to obtain hassle-free and swift permission to conduct the study. Responding to requests for information (Request for Information – RFI).