Clinical Trial ( I, II, III, IV Phases).

Study of pharmacokinetics and pharmacodynamics.

Writing up and elaboration of Clinical Research Protocols:
writing up of research protocols will be done in conformity with the SOPs (Standard Operative Procedure) of the Sponsor. The protocol can be written in Italian or English.

Writing up and elaboration of CRFs (Case Report Forms):
in conformity with the Sponsor’s SOPs and in the desired language.

Clinical site selection.

Clinical sites’ activation and contact with the Hospitals:
obtaining of ethical and administrative authorisations.

Investigator’s meeting organization.

Clinical Monitoring.

Data Cleaning and CRFs collection

Data elaboration and issuing of queries.

Close-out and Long Term Archiving.

Final Report:
in conformity with Sponsors’ SOPs and ICH (International Conference on Harmonisation).

Fee disbursement

Planning and organization of scientific training for Pharmaceutical Representatives:
this activity, carried out in cooperation with the establishment of training and / or the Sponsor’s Medical Direction, has the purpose to train / update the ISF on medical and scientific issues related to the specific product: knowledge of anatomy, physiology, pathology, related to the apparatus or the organ concerned, the mechanism of action, side effects related to study medication ...

Elaboration and drawing up product monographies:
the aim is to provide Pharmaceutical Representatives with a support document, the contents of which sum up all the main phases of the development and application of the drug. It is an aid whose contents sum up the main stages of the drug’s development and application.

Medical Writing:
the aim is to write up scientific proceedings as the editorial rules suggest. It will be carried out in Italian or English language.