Study set-up
As a consultancy company, we are aware that at times our Clients may require support in only selected activities in their clinical trials, projects known to usually be complex and multi-stage. This is why we offer flexible, customized solutions, designed to fit the purpose of our Clients. Our experience in the design and planning ranges from Phase I (including First in Human, FIH) to Phase IV clinical trials, and also observational studies.
The study set-up that we provide includes:
- 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 essential study documents being part of clinical trial application (CTA), 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(s),
- For medical devices, submission of the CTA to the appropriate Competent Authority (CA) and Bioethics Committee (BC), communication with CA/BC experts allowing to obtain hassle-free and swift permission to conduct the study,
- For medicinal products, submission of the CTA via the online clinical trial information system (CTIS), management of the CTIS application, timely responses to requests for information (RFI), ending in obtaining study approval.