Clinical Phase I & Phase II/III Trials

We provide our client a full package support in the transition from Pre-clinical to First in Human / Phase I clinical studies.

We actively cooperate with the San Matteo Phase I Clinical Trial Unit and Experimental Therapy, both for phase I studies in healthy volunteers and phase I/II in patients, covering a wide range of disciplines including pharmacokinetics, pharmacodynamics and safety evaluations

We can design and execute Clinical trials for Phase II in order to obtain some preliminary data on the effectiveness (e.g. Clinical Proof of Concept), short-term side effects and risks associated with your drug.

We can both advise in the clinical trial management and monitoring through all clinical phases of Development and provide direct control and monitoring, through our internal CRO service.

Here are some of the services we can provide:

Study Documents (I.B., Protocol Development and Preparation and Submission of CTA to ECs)
Study tools and supplies (Investigators' binders and Study Drug Management)
Initiation Activities (Central laboratory, Contract & Fees Negotiation, Conduct Site Qualification Visit)
Study Conduct (Interim and Close-out Visists, Telephone Contacts)
Study Management (Project Management and Study Reports)
Data Management (CRF-eCRF, Database, Medical Coding, Double Data Entry, Data Cleaning & Query Generation)
Biostatistics (Statistical Plan, Analisys and Report)
Medical Writing (Prepare Final report)
Study Documents Archiving
Medical-PharmacoVigilance (SAE/CIOMS Management)
Reporting of SUSARS to CA, ECs, Investigators and EudraVigilance
Annual Safety Report
Distribute Annual Safety Report to CA
Maintain Study Files/Ongoing Regulatory Document Collection
Records Management (in accordance with ICH (GCP) guidelines