CVBF has developed significant expertise in clinical trials (CTs) since 2002, first as Sponsor of no-profit studies and then also as Contract Research Organisation (CRO) providing services related to all phases of drug development.
Currently, CVBF is registered as a non-commercial Sponsor of CTs at the European Medicines Agency (EMA) as well as at the Italian Medicine Agency (Agenzia Italiana del Farmaco, AIFA), where it is also self-certified as CRO.
Many CVBF activities are conducted in the context of EU funded projects, however, CVBF provides also full CRO services to any category of Sponsors and for any type of products (e.g., drug, ATMP, medical device).
CVBF CRO writes and reviews a broad range of scientific documents based on the clients’ needs, performing also quality controls of all documents for compliance with the ICH standards and the strict EU regulatory requirements. CVBF CRO prepares any type of studies related documentations such as:
- Study protocol
- Investigator’s Brochure
- Information sheets and consent form
- Study-specific procedures and manuals
- Manuscripts for medical and scientific journals
- Posters and slide presentations
CVBF CRO gained an excellent experience on ethical-regulatory processes required for conducting any type of studies. CVBF CRO services include:
- Registration and update of the study in recognised international registries
- Preparation of the master submission package and its adaptation to national/local requirements
- Management of the study authorization process from submission to final approval
- Negotiation of contract with site(s)
- Preparation and management of substantial amendments
- Notification of the end of the study
Professional CVBF CRO staff ensures safety and consistency throughout CTs process. In specific, CVBF CRO pharmacovigilance services include:
- Support to EudraVigilance registration
- Definition of security section in clinical study protocol
- Safety Management Plan preparation
- Collection, processing, and reporting of Serious Adverse Events/Serious Adverse Reactions
- Medical review of safety data
- Collection, processing, and reporting of SUSAR (suspect unexpected serious adverse reactions) to Competent Authorities (through EudraVigilance, if applicable) and ethic committees, as well as distribution of line listing to investigators
- Preparation and submission of Development Safety Update Report to competent authorities and ethic committees
- MedDRA coding
MONITORING & SITE MANAGEMENT
Qualified and knowledgeable CVBF CRO professionals with extensive clinical research experience guarantee high level of CT monitoring and site management services. CVBF’s senior Clinical Research Associates (CRAs) have a minimum of 15 years in industry and academia. CVBF CRO staff performs regular training programme, and it is always up to date on National and European regulations revision.
In detail, CVBF CRO monitoring services are:
- Site identification & selection
- Site qualification & initiation
- Budget and contract negotiations with sites
- Ongoing site monitoring & management (performed both on-site and remotely, as needed)
- Regulatory document collection, review & management
- Centralized monitoring (with support of data management function)
TRIAL OPERATIONS/PROJECT MANAGEMENT
CVBF CRO manage all the activities related to study organization as well as lead preparation, activation, conduction, and reporting actions such as:
- Evaluation of study timelines, milestones, and planning
- Meetings/TCs organization (internal and external) in order to guarantee continuous update on the ongoing activities and of the activity plan
- Organization of events involving investigators (Investigator’s meetings)
- Coordination of site activation, monitoring and site management
- Supporting activities as management of investigational product, study material and study equipment
- Identification of central facilities to meet specific study requirements
- Preparation and maintenance of essential documents (TMF/ISF)
For each study, a CVBF CRO Project Manager (PM) will be identified with adequate experience according to the specific study characteristics and client’s needs. PM will coordinate the working team appointed for the study.
CVBF CRO provides a full range of services for clinical data collection and management.
CVBF CRO services lead to efficient managements of needs thanks to professional staff trained to maximize knowledge with innovative technologies, business processes, and attention to details. The data-management activities are organized at CVBF CRO to provide timely strategic information to the project team through the continuous monitoring of each single step of the study.
CVBF CRO services ranged among:
- Design and development of Case Report Form (CRF) (paper and electronic)
- Data Management Plan preparation
- Database design in accordance with CDISC/CDASH standards
- e-CRF hosting and backup
- Management of accesses to the e-CRF, training and technical user’s support
- Data management, data entry and database lock
- Medical coding (adverse events, concomitant medications, concomitant disease)
- Data cleaning
- Reconciliation of serious adverse events.
OTHER STRATEGIC SERVICES
Through the CVBF CRO world-class academic network, you have access to excellent experts with a deep and broad understanding of the requirements expected by regulators, which are crucial to design successful protocols in line with clients’ needs. Moreover, CVBF CRO offers translational services to introduce, in product pipelines, regulatory and technological innovations (e.g., advanced therapies, biologics, orphan drugs, and paediatric drugs) to your organisation. These CVBF CRO services include:
- Preparation of dossier for Orphan Designation, submission, and follow-up
- Preparation of Paediatric Investigation Plans (PIP), submission and follow-up
- Support the request for “Scientific Advice” and “Protocol Assistance”