PROJECT MANAGEMENT
Project management is a crucial aspect for the success of all clinical studies. SCF staff are able to coordinate and manage all the activities that are associated with clinical studies in order to assure correct planning, enrolment and surveillance, starting from specific training to Principal Investigator (PI) and study staff.
STUDY COORDINATOR / DATA MANAGER
Nowadays the data manager plays a pivotal role that supports both the project management, the PI and clinical research associate (CRA) activities, with the aim of reaching the desired study outcomes within the defined study duration. With these aims in mind, SCF has specialized data managers who can also operate in out-sourcing.
Definition of all data management activities:
- Gestione dei dati di uno studio clinico in conformità con le procedure di qualità
- Gestione dei source documents
- Organization of patient examinations
- Collaboration in patient selection (recruitment)
- Support for the clinical unit for the compilation of the Case Report Form (CRF), adverse event reports and Suspected Unexpected Serious Adverse Reactions (SUSARs)
- Update of the clinical database based on queries, resolutions and procedures defined in the Data Management Plan
- Management of drug accountability
STATISTICAL ANALYSES & DATA MANAGEMENT
Statistical analysis is an activity that accompanies the entire development of clinical studies. In fact, it is applied from the preliminary phase of protocol definitions to the final analysis of outcomes reached. Our statistical activities allow us to:
Le attività statistiche in outsourcing, comprendono:
- Calculate and define sample size
- Develop the Statistical Analysis Plan (SAP)
- Generate the randomization list of tables, listings and figures (TLF)
- Develop interim and final statistical analyses, including final report, also for paper publication for the Manage Data Monitoring Board (DMB)
To do this, SCF relies on experienced statisticians, operating solely on validated databases. software validati.
ATTIVITÀ REGOLATORIE
Thanks to its professional team, SCF represents the connection between Sponsor and Competent Authorities, developing all of the regulatory aspects required for clinical studies. All the activities are performed in compliance with international standards ICH (International Conference on Harmonisation) and GCP. These activities aim to obtain the authorizations, managing requests from Competent Authorities, minimizing the risks of delays.
Our dedicated staff prepare and submit the required clinical documents and amendments to Ethics Committees and Competent Authorities, and they are qualified to manage studies related to the National Monitoring Centre for Clinical Trials (OsSC) with Medicines, in compliance with the Italian and European requirements (EudraCT DB) for Clinical Trial electronic data transmission to the Competent Authority.
CLINICAL WRITING
The development of a well-defined synopsis, protocols and Investigational Brochure (IB), according to GCP, is the first and pivotal step that allows the identification of the endpoints and clinical outcomes to reach, along with the definition of the study population, inclusion and exclusion criteria. Our support allows the clear definition of these aspects, which is of primary importance to avoid delays in patient recruitment and achievement of clinical outcomes. Our staff support sponsors during the medical writing for the full life-cycle of a product’s development, beginning with the synopsis and protocol development, and ending with the production of the final report, also for paper submission.
ATTIVITÀ DI MONITORAGGIO
SCF offers a certified and experienced CRA professional in compliance with the Italian Ministerial Degree DM 15.11.2011, to provide monitoring support in all phases of clinical trials through the conduction of:
- Qualification visit of the clinical centres: Site Qualification Visit, Pre-Study Visit (PSV)
- Initiation visits (Study Initiation Visit – SIV)
- Site monitoring visits (Monitoring Visits – SMVs) and co-monitoring visits
- Visite di chiusura di fine studio (Visita di Chiusura –COV)
These activities are documented by site visit reports and follow-up letters.
Le attività del CRA non si limitano alle visite di monitoraggio, ma è in grado di svolgere attività complementari, quali:
- Acting as principal intermediary for communication between sponsor and investigators
- Education and training on site for the study staff concerning conduction and management of clinical studies, including assurance of regulatory and ICH/GCP compliance
- Supervisione dell’andamento dello studio clinico in conformità al protocollo, alle SOP e alle GCP
- Query and deviation management
- Verifica dell’andamento dell’arruolamento dei pazienti e del processo di acquisizione del consenso informato
- Management of drug accountability
- Raccolta e trattamento della documentazione studio-specifiche in conformità alle normative vigenti
Assicurazione della Qualità e attività di audit
A quality assurance (QA) system represents the foundation of a CRO’s activities. It consists of planned and systematic actions to ensure that a clinical trial is performed in compliance with the protocol, GCP guidelines and all other applicable regulatory requirements.
It intertwines with risk-based quality management in order to identify, assess and mitigate risks of the whole trial process.
Il sistema di gestione di Assicurazione Qualità di SCF si basa su un solido sistema procedurale costituito da informazioni documentate, in conformità alla GCP e norme vigenti.
Grazie alle attività del responsabile qualità e dell’auditor, SCF è in grado di supportare le aziende farmaceutiche nello svolgimento delle seguenti attività, essenziali per assicurare alti livelli di qualità:
- Preparation and revision of SOPs
- Implementazione del sistema di gestione della qualità
- Audit working papers
- Facility and system audits
- Attività correttive per migliorare e monitorare le prestazioni dei sistemi
- Attività formative (corsi di formazione GLP e GCP)
- Risk based management plan development
Clinical Data Manager
SCF provides services for gathering clinical data (Electronic Data Capture/EDC) and pays particular attention to the reduction in the times for the design of these. Starting from the development and validation of the database up to the optimization of the the user training and implementation of the EDC platform phases.
Le attività del Clinical Data Manager comprendono:
- pCRF/eCRF design (FDA 21 CFR Part 11)
- Database design and development
- Data Validation Plan preparation
- Data Cleaning
- Data Management
- DCF/Query Management
- Management of clinical data from external sources of the study (laboratories,data from device, images)
- Reconciliation of SAE
Data collected by eCRFs can be exported as SAS datasets or in other formats.