Consorzio per Valutazioni Biologiche e Farmacologiche – Dege e shoqerise se huaj, Albanian Branch Office, has been established in Tirana (Albania) in May 2015 acting as a full-service support to the overall clinical research strategy, offering one-stop local solutions to investigators, sponsors, Contract Research Organisations (CROs) and research institutions. Through research services such as medical writing (e.g. the preparation of study protocol and other documents), regulatory sciences (e.g. the preparation of regulatory applications), site management services (strategic research consultation and study feasibility assessment), project management, trial management (including study monitoring, data management, bio-statistics), it brings competences and internationally/European agreed standards on clinical research and regulatory sciences to a neighbouring non-EU country.

CVBF Albania is a branch of Consorzio per Valutazioni Biologiche e Farmacologiche, an italian not-for-profit consortium acting in the field of life sciences and biotechnologies since 2000, with the mission to perform research and provide scientific, economic and regulatory consultancy for innovation in the health sector at European level, with particular interest in paediatric and rare diseases fields.

CVBF Albania acts as a Contract Research Organization (CRO) to conduct GCP (Good Clinical Practice) clinical trials and supporting companies willing to conduct clinical research in Albania.

Projects and activities

CVBF Albania is member of TEDDY – European Network of Excellence for Paediatric Research, an independent multidisciplinary, multinational Network composed by 50 partners from 20 EU and non-EU countries aimed at facilitating the performance of good quality paediatric studies and research, category 1 member of Enpr-EMA, the European Network of Paediatric Research at the European Medicines Agency.

CVBF Albania is also an associate member of EUCROF (the European CRO Federation), a non-profit organization founded in 2005, with the objective to promote clinical research by improving the knowledge, competence/expertise and skills of Contract/Clinical Research Organisations (CROs) in Europe. The Federation develops training and educational programs for clinical research and shares information on developments in clinical research with health care professionals at international level.

EUCROF consists of members and associate members from 20 countries and stands for 300 member CROs.

In collaboration with the University Hospital Center “Mother Teresa”, service of paediatrics, Tirana, CVBF Albania is promoting a Young Persons Advisory Group (YPAG) named KIDS Albania, an organisation composed of youths actively participating as partners, advising researchers and their teams on a full range of activities in various research projects and initiatives.

CVBF Albania is involved in the implementation of the EU-funded research projects, DEEP and GAPP, at the University Hospital Center “Mother Teresa” Tirana and is involved as Third Party in the ID-EPTRI (European Paediatric Translational Research Infrastructure) project.

The ID-EPTRI project, coordinated by CVBF and submitted within the INFRADEV-2016-2017 single-stage call for proposals, is aimed to create the framework for a new paediatric Research Infrastructure (RI), EPTRI, that is complementary to the existing Biomed Research Infrastructures acting as a ‘Paediatric Common Service’ in the ESFRI Scenario. The project involves 26 partners from EU and non-EU countries including consolidated RIs, top-level universities, scientific and clinical centres of excellence in Europe and is aimed to create a Conceptual Design Report to realize the European paediatric RI.

EPTRI will be a “one-stop-shop” for advice in paediatric drug development with demonstrated capacity to bridge the existing gaps in paediatric medicines research by connecting the different steps in research from early stages, to enable and prepare researchers in many methodological areas to conduct research that effectively underpins the development of medicines in children, to increase the global competitiveness of the European RIs and the paediatric research also in favour of children, young people and their families.

The DEEP project, coordinated by CVBF, is aimed to study the efficacy and safety of deferiprone (the first oral iron chelators developed in Europe) in children affected by β-thalaessemia major and other transfusion dependent haemoglobinopathies. The project comprises 22 recruiting centres in EU (Cyprus, Greece, Italy, United Kingdom) and non-EU (Albania, Egypt, Tunisia) countries, scientific partners from allover Europe and a pharmaceutical group based in Canada. The project has the specific aim to produce a new oral liquid formulation of deferiprone suitable for paediatric use and to integrate the existing information on deferiprone use in iron overloaded paediatric patients.

More information on the DEEP project are available at official website: www.deepproject.eu

The GAPP project, coordinated by CVBF, intends to improve the therapeutic perspectives of children who suffer from chronic pain, providing them with a drug, gabapentin, which is supposed to be effective and safe, as already demonstrated in adults, and which was included in the European priority list of off-patent paediatric medicines worthy of research grants. Through the development of a Paediatric Investigation Plan (PIP) appropriate dosages, efficacy and safety of gabapentin in children older than 3 months will be assessed. The project involves two Italian companies committed in the development of a new formulation for neuropathic pain in children, European leading scientific institutions located in France, Italy, UK and the Netherlands, and 18 recruiting centres located in Albania, France, Germany, Greece, Italy, Poland, Ukraine and the Netherlands.

More information on the GAPP project are available at official website: www.pediatricpain.eu

 

In collaboration with the University Hospital Center “Mother Teresa”, CVBF Albania is also working to set up a Clinical Trial Center (CTC) in Tirana to facilitate the conduct of clinical research in paediatrics.