A flexible, multidimensional, global organization

CVBF

Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) is a not-for-profit research organisation founded in 2000 with the mission to perform research and education in the pharmaceutical field integrating management, monitoring, regulatory, clinical, epidemiological, economical, methodological and statistical expertise.

CVBF is a certified Contract Research Organisation (‘CRO’) authorised by the Italian Medicines Agency (AIFA) and has significant experience in the field of multicentre, multinational clinical studies, conducting research activities mainly in the context of EU funded projects by acting both as sponsor and/or CRO. It also coordinates two of these projects: DEEP – DEferiprone Evaluation in Paediatrics; and GAPP – GAbapentin in Paediatric Pain. In addition, CVBF is registered in EudraVigilance as a non-commercial sponsor of clinical trials, and is a member of scientific networks, INCiPiT and TEDDY, and the CRO associations AICRO and EUCROF.

The organisation provides services related to the following areas:

  • Clinical Trial Management
  • Clinical Sites selection and contracting
  • Clinical Operations and Drug Management
  • Data Management and Monitoring
  • Statistical Analysis and Medical Reporting
  • Pharmacovigilance

CVBF also manages the regulatory and ethical applications needed for the approval of new therapies and medicinal products: These invlove:

  • Clinical Trial Applications
  • Ethics Committees submissions
  • Dossiers for Orphan Designations
  • Paediatric Investigational Plans
  • Scientific Advices requests
  • Centralised Marketing Authorisation
  • Advanced Therapy

Furthermore, CVBF has accrued notable expertise and experience in project management and scientific coordination, and is currently involved in research and innovation activities of international projects (EJP RD – European Joint Programme Rare Diseases; EPTRI – European Paediatric Translational Research Infrastructure; conect4children (c4c) – COllaborative Network for European Clinical Trials For Children; PedCRIN – Paediatric Clinical Research Infrastructure Network).

Penta and CVBF have an important and long-standing collaboration, which was formalised with the signing of a Master Services Agreement in 2019. They first started working together in 2005, with the EU funded TEDDY – Task Force in Europe for Drug Development for the Young Network of Excellence (NoE), and continued with the ARPEC – Antibiotic Resistance and Prescribing in European Children project in 2010, GRiP Masters – Global Research in Paediatrics NoE in 2011, and NeoMero – “European multi-centre network to evaluate pharmacokinetics, safety and efficacy of Meropenem in neonatal sepsis and meningitis” project in 2013.

Currently, CVBF is providing services related to regulatory, data management and pharmacovigilance in the framework of SMILE (PENTA 17)– “Strategy for Maintenance of HIV suppression with elvitegravir-darunavir/ritonavir in children”, EPIICAL – “Early treated Perinatally HIV Infected individuals: Improving Children’s Actual Life” and NeoVanc – “Treatment of late onset bacterial sepsis caused by Vancomycin susceptible bacteria in neonates and infants aged under three months” project.