Case Histories

Collaborations have been established with different kinds of partners – ranging from small start-ups to well established pharma companies – in various therapeutic areas, including anticancer agents, anti-virals, antibiotics, cardiovascular, pain-killers, among others.

In most cases, the development stage of the candidate is early pre-clinical.

Support to our Clients may range from “full package” (entailing management of all activities required by the development program) to more limited ones, such as regulatory or licensing support, or conduction of well defined tasks within the development program, as clinical trials design and monitoring. Here are some examples of support provided to our Clients:

European Biotech - Full development program, from clinical candidate selection to phase I/II clinical trials for a potential anticancer agent
Diversification of a large, non-pharma Company, applying its technology to human therapy – Driving the development of a new therapeutic system for the treatment of solid tumors
New Start-up – Designing and implementing the development program for a first-in-class peptide antibiotic project
US biotech – Orphan Drug Des. and Protocol Assistance procedure at EMA, for a clinical stage candidate
Identification of licensees and co-development partners in Japan/Far East, for new antibiotic candidates (phase I, preclinical) originated by a European Biotech company

Regulatory support for the development of a cell product of an European Company, for the treatment of liver failure (late preclinical)

Phase I/II clinical trial conduction in Italy and Germany for a new clinical entity: from Clinical Trial Application to Competent Authorities, to clinical trial monitoring, data collection and analisys. Pharmacovigilance and Eudravigilance Management

Phase III clinical trial conduction (from CTA submission, to clinical trial monitoring, data analysis and report) for a biotech drug in neurological area.

Case Histories

European Biotech - Full development program, from clinical candidate selection to phase I/II clinical trials for a potential anticancer agent

Diversification of a large, non-pharma Company, applying its technology to human therapy – Driving the development of a new therapeutic system for the treatment of solid tumors

New Start-up – Designing and implementing the development program for a first-in-class peptide antibiotic project

US biotech – Orphan Drug Des. and Protocol Assistance procedure at EMA, for a clinical stage candidate

Identification of licensees and co-development partners in Japan/Far East, for new antibiotic candidates (phase I, preclinical) originated by a European Biotech company

Regulatory support for the development of a cell product of an European Company, for the treatment of liver failure (late preclinical)

Phase I/II clinical trial conduction in Italy and Germany for a new clinical entity: from Clinical Trial Application to Competent Authorities, to clinical trial monitoring, data collection and analisys. Pharmacovigilance and Eudravigilance Management

Phase III clinical trial conduction (from CTA submission, to clinical trial monitoring, data analysis and report) for a biotech drug in neurological area.

Regulatoty support to an European Company for Medical Devices pre-clinical and clinical Development in cardiovascular area