Services provided

The CTU-EOC is an academic research organization offering a comprehensive support for the implementation and conduct of clinical trials across all disease areas providing qualified services according to the International Conference on Harmonization (ICH) of Guidelines for Good Clinical Practice (GCP) and regulatory requirements. Academic and commercial sponsors can benefit from the available expertise in study design, regulatory submission, execution and reporting. The CTU-EOC can facilitate efficient start-up and provide assistance for manuscripts preparation and submission to scientific journals.

 

The CTU-EOC is available to EOC collaborators and external investigators including pharmaceutical industries. The first contact is free of charge.

The main services offered by the CTU-EOC are

  • Clinical Trial consulting
  • Project Management
  • Medical Writing
  • Regulatory Affairs
  • Clinical Trial logistics
  • Monitoring and quality control
  • Data Management
  • Biostatistics
  • Quality Assurance
  • Safety Desk

 

 

Clinical Trial Consulting
The CTU-EOC provides support to the investigators to help them in the conduct of clinical trials. Planning a clinical trial is the first step; the CTU-EOC can provide the support to prepare the scientific rationale and to advise on the most efficient study design.
Project Management
The CTU-EOC performs a feasibility analysis from the point of view of costs and resources together with the investigators. The CTU-EOC collects all requirements and provides the most comprehensive service. Inputs for the set-up of the clinical trial can be provided followed by planning, organization and implementation of it. Milestones and deliverables are agreed together with the investigators and activities are planned to make sure that deliverables are delivered on time.
Medical Writing
The CTU-EOC provides writing and publishing support for the preparation of regulatory documentation, according to ICH guidelines, for submission to Regulatory Authorities. Writing support is done in the preparation of:
  • Protocol, amendments
  • Subject information
  • Regulatory Authorities specific documentation
  • Case Report forms
  • Annual reports (DSUR)
  • Final reports
  • Manuscripts
Ethical Committee local documents can be prepared in Italian, German, French and English.
Regulatory Affairs
Advice and consulting for Regulatory Authorities submission can be provided. The CTU-EOC can also provide services by reviewing and submitting the clinical trial documentation to ensure regulatory compliance. CTU-EOC expertise is mainly based on the Swiss contest but can be enlarged to European Countries. The CTU-EOC takes care of the customized submission, respect of timelines and follow-up with regulatory agencies and Ethics Committees.
Clinical trial management
The CTU-EOC can benefit from highly qualified personnel with more than 15 years of experience in clinical trial management. The CTU-EOC provides support in terms of infrastructures, human resources and logistics. Clinical Trial Coordination, essential documents management, safety desk, support for study nursing and data entry can be provided.
Monitoring and data quality control
Modern monitoring strategies are more often proposed. The CTU-EOC has developed a risk based monitoring strategy customized to fulfill clinical trial objectives and patient safety criteria. Extension of Source Data verification is evaluated by taking into account a variety of aspects including protocol complexity, study drug/device, participating sites and others. Monitoring visit and quality control of the conduct of the clinical trial are provided.
Data Management
In-house electronic data capture can be provided. The CTU-EOC personnel discusses directly with the researcher the data collection requirements to ensure a correct and explanatory analysis of the trial. Data management processes have been developed to document and validate clinical trial database. MedDRA dictionary is used to code Adverse Events and SAS/SPSS, CDisc-ODM, CSV-TXT are used to prepare the database.
Biostatistics
The CTU-EOC provides statistical support for clinical trials including statistical design, analysis and interpretation of the data. The investigator can benefit of the statistical support to write the protocol, to plan the analysis (SAP) and to produce the study report.
Quality Assurance
A quality system has been implemented in the CTU-EOC and is managed by a Quality Assurance Manager who ensures adherence to the established processes. The quality of the CTU-EOC is guaranteed by regular internal audits performed by independent entities. The CTU-EOC also promotes Quality Assurance in the conduct of clinical trials. The CTU-EOC can provide Quality Assurance through audits done by long experienced auditors to investigators who want to ensure the high quality of their clinical trial at participating sites.
Safety Desk
Clinical trials with drugs/device are subject to the collection, detection, assessment, monitoring, and prevention of adverse effects related to the involved drugs/devices. The CTU-EOC can help the investigators in setting up the safety desk in accordance with national and international regulations.