Being the consultancy company, but also providing services as the Contract Research Organization (CRO), we are well aware that study Sponsors might choose to have several subcontractors and need support just in selected areas related to the conduct of clinical trials. This is why we offer customized solutions in terms of assistance in clinical trials, designed to fit the purpose of our Clients.
Our services can be limited to specific activities, from the areas below:
- Project management, risk analysis, a detailed work schedule implementation;
- Providing high quality clinical trial monitoring services in accordance with our GCP-compliant standard operating procedures;
- Supervision of bioanalytical laboratory and verification of work executed during the method development, validation and analysis of study samples;
- Providing pharmacovigilance services, adverse device effect and medical device deficiency notification, ongoing assessment of the usage of medicinal product/medical device and reporting of adverse reactions to the relevant Competent Authority and Bioethics Committee or via EudraVigilance system.
Trust, but verify and oversee.
We can do this for you!