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CRO ACTIVITIES

PROJECT MANAGEMENT

Project management is a crucial aspect for the success of all clinical studies.

Unifarm 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, Unifarm has specialized data managers who can also operate in out-sourcing.

Definition of all data management activities:

  • Management of clinical trial data in accordance with quality procedures
  • Maintenance of 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:

  • 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, Unifarm relies on experienced statisticians, operating solely on validated databases.

Data management is an integral part of statistical activities, which are necessary for:

  • Drafting a Data Management Plan
  • CRF and eCRF implementation (FDA CFR 21 part 11)
  • Development and maintenance of clinical databases
  • Validation of data with the use of edit checks and ad hoc electronic tools
  • Data encoding (Adverse Events and Concomitant Treatments)
  • Import and export of clinical data

REGULATORY ACTIVITIES

Thanks to its professional team, Unifarm 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.

PHARMACOVIGILANCE

Unifarm is a service provider of Responsible person for Pharmacovigilance, in outsourcing for the implementation of the activities, operating in compliance with Good Pharmacovigilance Practice (GVP):

  • Pharmacovigilance training
  • Standard Operating Procedure (SOP) design
  • EudraVigilance web reporting application (EVWEB) registration
  • Individual Case Study Report (ICSR) data collection, including Serious Adverse Events (SAE) and SUSAR
  • Medical and literature reviews
  • Preparation and submission of the Development Safety Update Report (DSUR)

Vigilance also includes the surveillance of food supplements and medical devices, which is carried-out in compliance with the respective legislations, and include:

 
  • SOP preparation
  • SAE reports collection
  • Notification to the regulatory body
  • Verification of data completeness
  • Transmission via the reference portal

MONITORING ACTIVITIES

Unifarm 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
  • Site closure visits at the end of the study (Close-Out Visit – COV)

These activities are documented by site visit reports and follow-up letters.

CRA activities are not limited to the conduction of monitoring visits, this professional also carries out the necessary complementary activities, including:

  • 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
  • Supervision of the trend of the clinical study in compliance with the protocol, SOPs and GCP
  • Query and deviation management
  • Verification of enrolment rate and informed consent process
  • Management of drug accountability
  • Notification of the pace of patient recruitment
  • Collection and processing of regulatory documentation for investigational studies in compliance with required guidelines
  • Conduction of monitoring activities in compliance with the monitoring plan

QUALITY ASSURANCE & AUDITING ACTIVITIES

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.

Unifarm’s quality assurance system is based on a robust procedural system based on SOPs. Our quality assurance system is designed to ensure that activities are developed in full compliance with GCP and regulatory requirements.

Thanks to the QA Specialist and the certified Auditor, Unifarm can support pharmaceutical companies in the development of quality assurance services, such as:

  • Preparation and revision of SOPs
  • Implementing a quality management system
  • Audit working papers
  • Facility and system audits
  • Continuous improvement and monitoring performance systems
  • Training programs: GLP and GCP courses for Investigators and CRAs
  • Risk based management plan development

FIRST-IN-MAN STUDIES

Unifarm has proven experience in managing operative and scientific issues of trials implying “first-in-man” new chemical entities. In collaboration with the Clinical Trial Unit (CTU) at the University Hospital Policlinico “Gaspare Rodolico – San Marco” in Catania.

Unifarm also supports companies in the conduction of phase I trials, according to the AIFA Determination 809/2015 on these types of trials.

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