Areas Heads
Monitoring & GCP Compliance Head
Alessandra Foietta
Alessandra is a senior Clinical Research Associate. Skilled in fostering cross-functional team collaboration, overseeing project finances, and enhancing client relationships for repeat business. Proven success in supporting team members in achieving KPIs, fostering career development and ensuring SOP compliance. Known for identifying potential issues and developing preventive solutions. Proficient in budget forecasting and monitoring clinical project scope, schedule, and costs to align with contract and financial performance targets.
Work experience:
20+ years’ experience working in clinical research for an Italian CRO (OPIS Srl) and for a multinational (Novartis Farma SpA), including 7 years as a Compliance & Training Manager and more recently, 5 years’ experience as a CRA Manager. Expertise in oncology area (mainly Ematology) in early compound and transplantation. Track record of driving clinical team performance to achieve superior project delivery, patient engagement, and site management.
Education:
Master of Science in Biology from the University of Milan. She has completed leadership trainings (M1 journey, coaching, giving feedback), change management, influencing for opportunity and storytelling.
Safety & Regulatory Head
Cristina Manfredi
Cristina leads the Regulatory and Safety Area at CVBF. She is EudraVigilance Specialist and Clinical Project Manager of an international project.
Work experience:
Strong experience in clinical research in the fields of Regulatory and Safety.
Education:
MA in Marketing Communication. Master in Bioethics for Clinical Trials and Ethics Committees.
Data and Site Management Head
Rosa Padula
Rosa is the Head of Data and Site Management Unit and a Clinical Project Manager at CVBF. She is also a Senior CRA.
Work experience:
Rosa has several years of experience in Clinical Research. Main area of activities: set-up of local/international project activities according to the company standards and regulations. Managing tasks/activities according to project-specific quality standards as well as relevant SOPs, ICH/GCP and local requirements. Preparation/Review of regulatory documentation for EC/AC submission. Editing and Review of trial documentations: protocol, CRF, ICF, IB. Contract negotiation and finalization with study sites. eCRF development, testing and management. Monitoring activities.
Education:
Master’s Degree in Chemistry.
Clinical Project Managers
Clinical Project Manager
Ana Dilo
Ana holds the roles of Clinical Project Manager with reference to multinational trials, and Training Manager, with reference to high level professional curricula, and webinars, delivered by European Consortia and Organisations.
Work experience:
Ana previously worked as pharmacist and then as Regulatory affairs & Pharmacovigilance responsible in a pharmaceutical company.
Education:
Master degree in Pharmacy from University of Medicine Tirana (Albania) and Master of Advanced Studies in Toxicology from University of Geneva (Switzerland).
Clinical Project Manager
Arlinda Demeti
Arlinda is a Clinical Project Manager at CVBF. Previously she has worked as a Clinical Research Associate for international studies having clinical sites in Albania, Germany, Italy, and Switzerland.
Work experience:
Arlinda has been working under the Directorate of Health and Social Projects at the Ministry of Health and Social Protection in Albania where she was involved in several health projects focusing on the digitalisation of Albanian Health System (e-referral, e-prescriptionin, human resource management system, e-social services registry). Further, Arlinda was part of the research unit at the Swiss Paraplegic Center in Notwill/Switzerland where she also performed practical work in the biobanking laboratory with the latest methodologies and devices to isolate cells, DNA, RNA. In addition, she has been working as retail pharmacist and technical manager pharmacist for 4 years in Albania in both pharmacy and pharmaceutical warehouse.
Education:
Arlinda Demeti holds a Master of Science degree in Pharmacy from the University of Tirana (Albania), and a Master of Arts in Health Sciences at the University of Lucerne (Switzerland) with a major in Health Services and Systems Research.
Clinical Project Manager
Claudia Pansieri
Claudia works as a Clinical Project Manager in CVBF. She is an expert in health data and participates in international projects.
Work experience:
Research Fellow at HUNIMED-Humanitas University and at IRCCS Mario Negri, where she developed skills in project development, clinical epidemiology, longitudinal research, and evidence synthesis (by means of systematic reviews and meta-analyses) to inform health care decisions. She is author and co-author of several scientific publications in national and international journals.
Education:
Master’s Degree in Chemistry and Pharmaceutical Technology. Master of Philosophy in Life and Biomedical Science.
Clinical Project Manager
Irisi Sukaj
Irisi holds the role of Regulatory Officer at CVBF, and Clinical Project Manager with reference to multinational trials, working in several languages (Albanian, English, French, German, Italian).
Work experience:
A highly experienced professional in Drug Regulatory Affairs with more than 12 years involvement in the sector, Irisi Sukaj has successfully held the position of Head of Regulatory Affairs and Pharmacovigilance Department in the only Albanian Pharmaceutical Industry for over 10 years.
Education:
Irisi Sukaj concluded the general high-school in her hometown in Albania with excellent results. She holds an Integrated Diploma of 2nd degree in Pharmacy from the University of Tirana and a 2nd level Master degree from the University of Camerino, Italy in “Hospital and Territorial Pharmacy”.
Clinical Project Manager
Ornela Cullufe
Ornela is the Office Manager at the Tirana branch office of CVBF, and works as Clinical Research Associate and Clinical Project Manager. She is the Team Leader of the first YPAG (Young People Advisory Group) in Albania named KIDS Albania part of iCAN (International Children’s Advisory Network).
Work experience:
Ornela worked as pharmacist with extensive background in patient care, pharmacology, communication and implementation of health care programs.
Education:
She obtained her master’s degree in Pharmacy in 2014 from University of Medicine in Tirana (Albania).
Clinical Project Manager
Silvia Pulici
Silvia is a Clinical Project Manager and a Senior CRA at CVBF.
Work experience:
Silvia worked 15 years in a pharmaceutical company first in Pre-Clinical Research, then in Clinical Research as Monitor and Associate Manager for clinical trial management. From 2008, she collaborated with San Matteo Hospital in Pavia, for 9 years, working at the Scientific Secretary of the Ethics Committee. She was involved as part of the Clinical Trial Quality Team of the Hospital in activities for improvement of quality of non-profit studies. She also collaborated in the activation of the San Matteo Phase I Clinical Trial Unit.
Education:
Master’s Degree in Pharmaceutical Chemistry and Technology.
Team Members
Legal Officer
Benedetta Mascolo
Benedetta has been appointed as Legal Officer at CVBF and Regulatory Officer in training.
Work experience:
In 2021, she began her career in clinical trials as a data manager after a successful application for a fellowship at Policlinico of Foggia.
Education:
Master’s Degree in Law at the “Roma Tre” University. Second-level master’s degree at the D’Annunzio University of Chieti-Pescara. She obtained the qualification to practice as a Lawyer.
Clinical Research Associate
Clara La Bruna
Clara collaborates with CVBF as a Clinical Research Associate.
Work experience:
She worked as Pharmacist; She holds the role of Pharmacovigilance Officer at Garibaldi Hospital in Catania.
Education:
Master’s Degree in Pharmacy. Master of II level in Pharmacovigilance. Clinical Research Associate Certification at LNAge higher education school in Rome.
Data Manager
Daniele Giachello
Daniele holds the role of Data Manager at CVBF and is involved in all the activities of a clinical study at the Burlo Garofolo paediatric IRCCS.
Work experience:
Daniele worked as scholarship holder for Istituto Neurologico Carlo Besta, where he was part of the Laboratory of Movement Disorders and worked on genetic testing via sanger sequencing.
Education:
Bachelor’s Degree of Biotechnology at the University of Milan and Master’s Degree in Medical Biotechnology and Molecular Medicine.
Human Resource Officer
& Trial Archivist
Elisa Cattani
Elisa works at the Pavia office of CVBF as Human Resource Officer and Trial Archivist, in which she collects and stores all the documentation related to clinical studies, provides assistance to the Quality area and holds the role of Office Manager.
Work experience:
Elisa previously worked as secretary at Studio Legale Fieschi-Avico-Tullio.
Education:
Graduation of company secretary at “Istituto Professionale di Stato per i Servizi Commerciali “L. COSSA”
Regulatory Officer
Elisa Zucca
Elisa works as a Regulatory Officer in CVBF.
Work experience:
Elisa has worked for more than 10 years with an In vitro Medical Device company, first as Research and Development Scientist and then as Regulatory Affairs Specialist where she developed skills in Medical Device design control, quality assurance and technical documentation drafting.
Education:
Master’s Degree in Medical and Pharmaceutical Biotechnology. Master of Philosophy in Biomolecular Sciences and Biotechnologies.
Marketing Manager
Flogert Dollani
Flogert currently works at the Pavia branch office of CVBF as Marketing Manager.
Work experience:
Flogert has worked for more than 10 years with multinational pharma companies, such as NovoNordisk and Servier in Sales and Marketing.
Education:
Flogert holds a Master of Science degree in Pharmacy from the University of Tirana, Albania. Prior to that, he has studied at the University of Florence (Italy), in the Faculty of Pharmacy – course of “Quality Control in the Pharmaceutical Industry”.
Safety Officer
Francesca Cadile
Francesca joined CVBF as a Pharmacovigilance and Safety Officer.
Education:
Francesca holds a Bachelor’s Degree in Biotechnology from the University of Messina, Master’s Degree in Medical and Pharmaceutical Biotechnology from the University of Pavia and a Ph.D. in Translational Medicine at the Department of Molecular Medicine – Human Physiology Unit at the University of Pavia. Francesca attended a training course of 50 hours in Clinical Research (as per DMC 15/11/2011).
IT Consultant
Gianluca Nanoia
Gianluca is an IT consultant of CVBF.
Work experience:
Gianluca has a strong professional experience providing IT consulting services for various companies.
Education:
Gianluca has obtained several certifications Microsoft, HP and VMWARE.
Clinical Research Associate
Justyna Szpotan
Justyna collaborates as a Clinical Research Associate in CVBF, as a a resource in outsourcing.
Work experience:
Justyna is currently working as a Project Manager and has over two years of experience as a Clinical Research Associate. She has been involved in on‑site and remote monitoring activities in Phase III and IV clinical trials, ensuring compliance with ICH‑GCP and regulatory requirements. She has been responsible for the preparation and submission of required study documentation within the Clinical Trials Information System (CTIS).
Education:
Justyna holds a PhD in Medical Sciences (Medical Biology), Master’s and Bachelor’s degrees in Biotechnology. She has completed postgraduate studies in non‑commercial clinical trials and is pursuing postgraduate studies in innovation in the medical technology market. Her education is complemented by extensive international academic and research experience gained through programs and scientific internships in Austria, Italy, and the United States.
Regulatory Officer
Laura Villani
At CVBF Laura operates as Regulatory Officer, supporting EU and extra EEA Sponsors in the preparation and submission of the clinical trial application dossier on investigational medical products.
Work experience:
She worked for several years as Molecular Biologist in the Haematologic Research area in public Institutes for Hospitalization and Care of a Scientific Character (IRCCS). After attending the Advanced Training Course as “Specialist in Biomedical Research” she obtained the Clinical Research Associate (CRA) certification according to the provisions of the D.M. November 15, 2011, Art 4.
Education:
Laura holds a Master’s Degree in Biological Sciences.
ISMS Responsible Person
Luca Forlani
Luca is the Information Security Management System Responsible Person of CVBF.
Work experience:
Luca has a strong professional experience providing IT consulting services for various companies.
Education:
Master’s Degree in Engineering at Polytechnic University of Milan. He holds a I level Master’s Degree in Professional writing for the web, virtual communities, e-learning, e-marketing. He obteined the Zyxel professional certification.
Clinical Research Associate
Marco Grisetti
Marco currently holds the role of Clinical Research Associate at CVBF.
Work experience:
Marco has worked for three years in a pharmacology laboratory at the University of Milano-Bicocca, including two years as an intern and one year as a research grant holder, focusing on preclinical research in the field of neurodegenerative diseases.
Education:
Marco completed a Bachelor’s degree in Biotechnology and a Master’s degree in Medical Biotechnology, both at the University of Milano-Bicocca. He also has attended a Clinical Research Associate (CRA) training course organized by AICRO.
Quality Assurance Manager
Maria Rita Fagone
Maria Rita joined CVBF as Quality Assurance Manager.
Work experience:
Maria Rita performed an internship at the “Laboratory of Biocompatible Polymers” from the University of Palermo and another internship as pharmacist.
Education:
Master’s Degree in Chemistry and Pharmaceutical Technology. Maria Rita decided to undertake a masterclass called “MYCROSCOPE” managed by A.I.C.R.O – Italian Association of Contract Research Organization. She attended the training course “Clinical Quality Assurance: un ruolo chiave nella ricerca clinica”.
Data & IT Manager
Maria Paola Felisi
Mariapaola works at CVBF as Data Manager and as IT Manager.
Work experience:
Mariapaola has a significant experience in ISO Quality Management Systems and Data Management.
Education:
Technical diploma and advanced training course in Networking and Systems Administration.
Regulatory Officer
and Billing Manager
Marina Montanaro
Marina works at CVBF in quality of Regulatory Officer and Billing Manager.
Work experience:
Expert in financial reporting and member of the Project Management Team for FP7 and Horizon 2020 Projects. Member of the Project Management Team and Financial Manager of ID-EPTRI Project, Administrative Manager of the DEEP Project, member of the DEEP Trial Management Team.
Education:
Master’s Degree in Business administration.
Clinical Research Associate
Marta Gionfra
Marta currently holds the role of Clinical Research Associate at CVBF.
Work experience:
Marta worked as pharmacist. She performed a traineeship in order to become a Clinical Research Associate.
Education:
Marta obtained a Master’s Degree in Pharmaceutical Chemistry and Technology. She has got an II level Master in Monitoring, insurance and quality control in clinical trials from “La Sapienza” University of Rome.
Quality Assurance Manager
and Safety Officer
Sara Oliveri
Sara is a Quality Assurance Manager and Safety Officer at CVBF.
Work experience:
Internship at the “Toxicology and Pharmacology Laboratory” from the University of Pavia.
Education:
Advanced Master’s Degree in Regulatory Affairs – G. Benzi (on going) – University of Pavia Master’s Degree in Experimental and Applied Biology in Biomedical field – University of Pavia Bachelor’s Degree in Biology – University of Pavia.
Data Protection Officer
Sergio Cannavò
Sergio joined CVBF as a Data Protection Officer (DPO) providing its knowledge on Privacy field.
Work experience:
Sergio is a Lawyer with deep experience in Environmental Law. He has also been a lecturer for several courses on specific issues of Environmental Law. Since 2019 he provides advice on consulting and training on privacy (GDPR), safety at work (D. Lgs.81/2008) and administrative responsibility of the entities (D. Lgs. 231/2001).
Education:
Master’s Degree in Law. He attended many training courses on Environmental Law, Privacy and Safety at Work.
Regulatory Officer
Stefania Quintavalle
Stefania currently works as a Regulatory Officer and Clinical Trial Assistant in CVBF.
Work experience:
Stefania worked as Pharmacist.
Education:
Stefania obtained a Master’s Degree in Pharmacy at the University of Bari “Aldo Moro”. She carried out a Post-graduate Degree “Territorial pharmacist – hard skills & career”. She performed a Clinical research Training course “Missione CRA”.