To conduct Phase I to Phase IV clinical trials for sponsors, we provide the following services in compliance with local regulatory requirements.
Evaluation of the feasibility :
- write and validate a specific feasibility study questionnaire
- selection and validation of investigation centers, in terms of
- Recruitment capacity
- Technical and logistics resources
- Experience in the conduct of clinical trials,
- Motivation and time available for the project
This can be achieve in addition to the feasibility assessment performed by the sponsor itself in order to ensure good-quality, and reliable data.
Training of investigators and nurses involved in the clinical trial.
Regulatory affairs:
Preparation and submission of EU Clinical Trial Applications, including IMPDs of all types and complexity. We can also arrange meetings with key worldwide regulatory authorities and support you in the preparation of the supporting documentation.
Logistic organization:
Pre selection visit (to outline the activities required to facilitate the investigational site selection process), Site initiation visit, Monitoring Visit and Close-Out Visit.
Project management: regulatory process optimization, management monitoring, etc.
Our offer is flexible and we can also work on all of the above or simply on one or several modules.