The main tasks of the Institutional functions are regulated by the Statute of Consorzio per Valutazioni Biologiche e
Farmacologiche (CVBF).
The Institutional Organs supervise the operation of the Consortium, establishing the organizational structure and allocating
the resources (human, material, technological, financial resources) needed to reach the CVBF objectives.

The Chief Executive Officer (CEO) represents legally the CVBF, along with the President, and he/she is responsible of the legal, financial and administrative aspects, as well as of what foreseen in the Statute. His/ her tasks are:

• • Deal with the preparation of the annual balance sheets, in collaboration with external consultants;

• • Monitor the economic and financial needs and identify appropriate solutions;

• • Negotiate and subscribe agreements of partnership and collaboration;

• • Represent the Consortium towards Third Parties, subscribe contracts with clients and providers;

• • Entrust tasks not otherwise contemplated in the corporate organization.

The CEO tasks are executed in all the Consortium sites in Italy and abroad.

The Administrative Director tasks are:

• Supervise the accounting and financial management;
• Approve the technical-administrative reports prepared under the Project Managers responsibility;
• Coordinate the activities of the organization along with the Project Direction, delegate to the Area Coordinator the specific activities they are responsible for;
• Define and appoint, along with the Project Direction, the team for each project, the roles, the responsibilities and the tasks of the team components, on the proposal of the appointed Project Manager.

The Administrative Direction is the direct responsible of the Areas: Administration, Communication and Training,
Development & Networking.

The Scientific Director is part of the CVBF Direction together with the Administrative Director and the Projects Director, and he/she is in charge of addressing the CVBF scientific activities, collaborating to the programme and scientific activities preparation, also through the coordination of the Scientific Committee tasks. The Scientific Director:

• participate in meetings and congresses also in order to develop and maintain relationships with external strategic partners and stakeholders;
• reviews and approves the technical-scientific outputs of CVBF activities and the scientific publications;
• contributes with scientific inputs and contents to the development of new projects, since their submission to the concerned funding authorities or companies;
• Prepares and reviews the annual research plans of the CVBF;
• Suggests to the Board of Directors and the Assembly the programmatic lines for the development of the CVBF scientific activities..

The Projects Director carries out activities necessary to promote the growth of the projects and services provided by CVBF. In particular, he/she has the following tasks:

• Relate with the main CVBF partners and clients;
• Coordinate the activities of the organization along with the Administrative Director and delegate to the Areas Coordinators the specific activities they are responsible for;
• Define and appoint along with the Administrative Direction the team for each project, the roles, the responsibilities and the tasks of the team components, on the proposal of the Project Manager;
• Approve the technical-scientific reports prepared under the Project Managers responsibility;

The Project Director is the Direction reference person for the following Areas: Quality Assurance, Information System, Regulatory & Pharmacovigilance, Trial Management & Monitoring, Research & Data Sharing.

The Project Manager ensures the respect of the timing and the results foreseen by the project, the production of the expected outputs and deliverables and the achievement of the technical-scientific objectives. The Project Manager guarantees the effective use of the resources, based on the budget of the project and the reference contract documentation. He/she reports to the Direction the progress and the achievement of the objectives, as well as the use of the resources and tools. The PM can be assisted by appointed administrative manager and collaborators for the project. In case of complex projects, further people can be identified as responsible for specific parts or work packages of the same project.

• Identify the strategic lines for the proper conduction of the project;
• Define the needs of the human resources (in terms of expertise and tasks), goods and services to be used for the project and submit the project budget to the Administrative Direction periodically
• Plan the development phases of the project and its controls;
• Monitor the activities of the team and provide the technical-methodological support;
• Relate to the Reference Direction about the expertise of the resources in order to suggest some changes;
• Delegate to the collaborators and any other appointed manager the execution of specific parts of the project;
• Monitor reports and results of the project, defining needed actions for any issue during the progress of the project;
• Interact with external referents identified for specific technical-scientific aspects of the project;
• Submit to the approval of the Scientific Direction relevant project’s document (deliverables, publications, etc);
• Submit to the approval of the Reference Direction the technical-scientific reports and any other documents, eventually along with the Scientific Direction approval.

The collaborator participates to the activities of the projects for which he/she is appointed and respond to the Project Managers.

The Area Coordinator refers to the activities of his/her area of expertise and reports to the Direction on the qualification and development of resources. His/her tasks are:

• support CVBF activities in his/her competence field towards external subjects and within the organization;
• monitor the development of the activities within the area in terms of quality and quantity and suggest to the Direction the actions to solve any issue to foster the development;
• deal with the professional improvement of HR in the area and submit the training plans to the Direction for approval;
• suggest to the Direction a plan of renewal of working methodologies, goods and services for the activities of the Area.

The resources operating in this Area carry out the activities related to the project and the administrative management, and relate with the external consultants to ensure the fulfilment of the administrative and fiscal obligations. The main activities are:

• Deal with the management of the funded projects and support the Project Managers;
• Fill the reporting forms of the projects and store the support documentation;
• Manage the qualification process of suppliers and verify purchase orders before submitting to the signature of the relevant functions (arrange purchase orders and deal with suppliers);
• Handle the purchase processes, from the estimates acquisition to the proper execution of the supplies;
• Perform cash checks, banks, and purchase / sales bills;
• Deal with the receipts and payments;
• Store the contract documents and the copy of the accounting, financial and administrative documents related to the clients and suppliers, personnel and collaborators, partners and reference institutions;
• Directly manage or provide external consultants with all the data necessary for the upgrade of accounting records, the preparation of the financial fulfilments, as well as the revision activities;
• Handle the mail, legal mail, protocol and archives.

The resources operating in this area provide scientific support to all the activities carried out. In particular, the Scientific Assistant operates in strictly collaboration with the Scientific Director participating to:

• the drafting of projects application;
• the drafting, revision and management of the publications coming from the CVBF projects;
• the preparation of scientific contents for the communication area;
• the medical writing activities in the framework of clinical studies (protocol, IB, IMPD, clinical study reports, etc

The resources operating in this area, have the following tasks:

• Identify the technologies (hardware, software, infrastructure, communication) that respond to the informative and management needs of the organization;
• Update periodically and suggest to the Direction a supplying plan of such technologies, In collaboration with the Project Managers and the Area Coordinators;
• Define and manage the process of IS and the IT services supply (teleconferences facilities, internal data management system, email accounts, software and antiviruses, backups procedures, passwords, etc.;
• Support Data Controller/Data Processors in guaranteeing data security and compliance with the applicable regulations;
• Handle the issues related to web sites and IT resources and tools, in collaboration with the project managers and the Administrative and Communication & Training Areas;
• Give advice on privacy issues and on the Data Protection Impact Assessment acting as Data Protection Officer (DPO).

The resources operating in this area provide support in the application and the improvement of the quality system. In particular, the QA has the following tasks:

• Prepare and update the Quality Manual and the other SGQ documents, their release and diffusion;
• Collaborate to define the necessary actions for the SGQ monitoring and improvement;
• Verify the efficacy and the realization of the corrective and preventive actions;
• Handle any audit for the suppliers (general and professional services);
• Handle the control process on SGQ, planning the internal audits and keeping the records updated;
• Record the training activities of the collaborators and store the documentation.

Moreover, he/she is responsible for:

• Preparing the standard operating procedures in order to guarantee that the clinical studies conducted by CVBF as Sponsor or CRO are conducted and the data are recorded in compliance with the protocol and with the GCP;
• Ensuring that the resources involved in the clinical studies are trained properly;
• Performing controls through internal procedures or in collaboration with external professionals on the activities and the documents related to the clinical studies and checking whether the activities have been carried out properly, and the data have been recorded, analysed and communicated in compliance with the protocol, the SOPs and the GCP;
• Performing controls during each phase of the data management in order to guarantee the reliability and the proper preparation of the data;

  The Office Managers (OMs) in Bari and Pavia are part of the QA Area and have the following tasks:

• Support the Direction for HR management and internal communication;
• Manage offices assuring availability and maintenance of facilities, hardware and software, utilities and consumables;
• Handle application and screening of CVs, planning interviews and providing feedback to the candidates;
• Guarantee to all resources appropriate work space, documents and information on the organization and its rules;
• Deal with all documentation related to the human resources, such as CVs, personal profiles, registries of presence;
• Keep the HR calendar updated with absences, missions, training courses, conferences, etc. Handle the application and the screening of the CVs, planning interviews and providing the feedback to the candidates;

The resources operating in this area provide support in the:

• Organization of events and meetings;
• Preparation of informative materials (brochures, presentations, audio and video materials, leaflets);
• Management of web mail services, web sites and social media;
• Management of the on-line training courses;
• Dissemination and communication of the project activities.

Development activities are aimed at the acquisition of national and international research projects and consist in:

• seeking funding opportunities;
• preparation of funding applications including writing, partner management, budget definition, etc.;
• submission of applications and the overall management of application.

The networking activities are aimed to support the development activities and to favour the collaboration and interaction with many stakeholders, facilitating the transfer of the achieved know-how at different levels, leading to a strengthening of the scientific excellence promoting national and international research.

Management activities of the ethical-administrative authorization process for clinical studies.

• Management of the requests for changes and clarifications by the Ethic Committee and Competent Authorities;
• Compiling of the Clinical Trial Application (CTA) Form for the submission of the authorization request, and amendment;
• Insertion of data in the OsSC- Osservatorio Nazionale per la Sperimentazione Clinica dei Medicinali and Observational Studies Register – RSO (opening and closing of the centres, conclusion of the study, insertion of the final results);
• Activities to evaluate the safety profile of the drug in the study by collecting, monitoring and analysing the serious adverse events (SAE) and the SAE queries;
• Management and reporting of suspected and unexpected serious adverse reactions (SUSAR) to Ethics Committees, Experts and Competent Authorities (through EudraVigilance);
• Preparation and submission of the Development Safety Update Report (DSUR) to the Ethics Committees and competent authorities.

The trial management activity includes the activation of the clinical centres, coordination and support to all the functions in the clinical studies, the planning of the monitoring activities, of the Investigator meetings and of the study team meetings. The monitoring activities consist in the supervision of the trend of the clinical study in order to guarantee that the study is conducted, recorded and reported in compliance with the protocol, the Standard Operative Procedures (SOP) and the Good Clinical Practice (GCP). In particular, such activities include the monitoring visits as well as the redaction of the reports (qualification, initiation, monitoring, close-out).
The drug management activities consist in the coordination of the logistic processes of the IMP involved in the clinical trials, support the clinical Centres in the processes of storage, utilization and destruction of the IMP, in accordance with the protocol, the SOP and the GCP.
Management of data archives collected during clinical trial and clinical databases by means of specific controls intended to guarantee the reliability of the data and the respect of the information security, include: CRF design; preparation of the Data Management Plan; encoding of the medical terms by means of international dictionaries (MedDRA and WHO-DDE); management of inconsistencies emerged with the consistency check and plausibility of the collected data, database lock and data release for statistical analysis.

CVBF provides its expertise for the creation and development of IT systems allowing efficient sharing of research data,
generated at national and international level both in the context of preclinical and clinical research and in medical practice.
The main activities are aimed at promoting paediatric “technology-driven” research characterized by a more efficient and conscious use of data at European level. The data are processed in compliance with current regulations (General Data Protection Regulation, GDPR) with regard to privacy and security and IT solutions are adopted using the most common standards for encoding and collecting data and information, ensuring at the same time the uniformity of the collected data and the interoperability between different platforms.