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HOME SERVICES DRUG DEV. CLINICAL TRIALS REGULATORY CASE HISTORY CONTACT

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 Intro 8

                    

ISO 2008

case  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 1/2 clinical trials for a potential anticancer agent

  • 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

  • Regulatory support for the development of a cell product of an European Company, for the treatment of liver failure in newborn (late preclinical and phase 1)

  • Phase 1/2 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 3 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.

  • Regulatory support to an European Company to get CE Mark and (510)k clearance for a Medical Device intended to process lipoaspirate adipose tissue for autologous and homofunctional transplantation.

  • Regulatory and clinical support to an Academic Institution for the First in Human approval of a T-cell Therapy in patients with carcinoma.