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The San Matteo Phase I Unit performs Phase I and initial Phase II clinical studies and provides the following services: 

  1. Counseling for overall protocol design, and set up of experimental clinical trials
  2. Regulatory Assistance for Clinical Trials
  3. CRF design
  4. Study Monitoring
  5. Biostatistics
  6. Pharmacokinetics
  7. Internal QA Activities and Audit
  8. Final Report

 1. Counseling for overall protocol design, and set up of experimental clinical trials
San Matteo Phase I Unit offers an overall evaluation of project development in compliance with GCPs, thus facilitating a preliminary overview of the efforts needed to achieve the project objectives.
Moreover, within the Institution, there is a facility that provides support for immunohematological assessment of phase I study validation for novel therapeutic agents.

 2. Regulatory Assistance for Clinical Trials
On behalf of Sponsors, the San Matteo Phase I Unit will address all regulatory matters.
The San Matteo Phase I Unit will prepare the documentation for Ethics Committee review and Competent Authority approval.

 3. CRF design
The San Matteo Phase I Unit staff has experience in Case Report Form creation. To meet Sponsor requirements, all CRF format types are available, starting from non carbon paper CRF (the basic solution for Phase I studies performed at our Unit), to triplex copy carbon paper up to the more technological e-CRF solutions, with particular attention given to security aspects. The data management team provides a well-designed CRF, where all information required by the protocol is collected and registered.

4. Monitoring
At the San Matteo Phase I Unit there are on-going trials, which are monitored by permanent CTQT Foundation staff. 100% of source data verification is performed while monitoring reports are sent to the Sponsor in a timely manner.

5. Biostatistics
Our statistical department is involved in the entire study process, beginning with the design stage. They help define the study objectives, sample size calculation and statistical analysis plan (SAP), as well as data management process and analysis of data. The statistical and data management team can manage clinical data from Phase I to Phase IV using state of the art computational programs.
Data management and biostatistics are based on pertinent ICH guidelines and on local Standard Operating Procedures (SOPs). Strict quality control methods are applied throughout all study phases.
The team uses up-to-date technologies for both data management and data analysis, in compliance with international regulatory requirements (FDA, EMA, etc).
The team has extensive experience in planning every phase, from protocol development and initial CRF design to production of report Tables, Figures and Listings (TFLs) to satisfy the Sponsors’ needs. The procedures in place guarantee the delivery of high quality data within tight timelines and the fulfillment of regulatory requirements  

Data Management
Correct handling of data is fundamental for the success of any trial. San Matteo Phase I Unit data management system security is ensured by strict rules for access and use, arranged by user or user groups and includes: planned backup processes and suitable protection against external access. San Matteo Phase I Unit offers the following services in order to ensure that the Sponsors’s data management study goals are achieved:   

•    Data Management Plan (DMP) and Data Validation Plan (DVP): Key documents to ensure quality management of data. They contain all the specifications to facilitate management and validation of clinical data, for the entire lifecycle of data from conception to edit checks and control of the data
•    Database design using certified software. Validation checks are programmed during database design
•    Paper or electronic data capture according to Sponsor requirements, with implementation of appropriate procedures, documentation, audit tracking and security
•    Medical coding carried out utilizing MedDRA and WHO DD dictionaries
•    Data receipt and CRF tracking
•    SAE (Serious adverse events) reconciliation
•    Database release and lock
•    Data transfer from/in various formats for data manipulation and statistical analysis

Statistical Analysis
The San Matteo Phase I Unit in collaboration with the Statistical Department offers the following services:
•    Statistical input to protocol design
•    Experimental design choice
•    Calculation of sample size and power considerations
•    Choice of randomization methods and generation of randomization list
•    Definition of the statistical analysis plan (SAP) in accordance with the protocol
•    Preparation of statistical tables, figures and relevant listings
•    Statistical review of clinical study report
•    Support for publication
•    Post-hoc analyses upon Sponsor’s request
•    All procedures and program codes are archived to guarantee reproducibility

Certified software is used (e.g. Stata, Stata Corporation College Station, TX)


6. Pharmacokinetics
The San Matteo Phase I Unit provides comprehensive and flexible pharmacokinetic (PK) and pharmacodynamic (PD) support for Phase I/II clinical trials. The Unit is involved in defining study design, development of analytical assays, sampling times, PK/PD analysis type, dedicated statistical tests and PK/PD parameters of interest. The clinical pharmacology group is skilled and experienced in the analysis and interpretation of PK/PD data, providing assessment of clinical relevance and insight into results for use in the Sponsor’s drug development decisions. The following PK services are available:

1. Development of Analytical and Bio-analytical Methods to support all PK studies
a. Assay development & validation
    1. HPLC-MS/MS assays
    2. ELISA assays for the detection/determination of AbMo in biological fluids
b. Assay of biological samples

2. PK and PK/PD Data Analysis

a. Compartmental and non-compartmental PK analysis and modeling
b. PK/PD modeling, useful in proving the therapeutic value of a new pharmaceutical versus similar marketed drug
c. In vivo/in vitro correlations
d. Average population and individual bioavailability (BA) and bioequivalence (BE) assessments
e. Review of all PK parameters and concentration-vs-time profiles
f. Evaluation of linear and nonlinear pharmacokinetics

7. QA Activities and Audit
The San Matteo Phase I Unit enforces the highest quality standards to ensure that all activities are performed and data are generated, recorded, and reported in compliance with ICH-GCP and the applicable regulatory requirement(s). Quality is ensured through: Documented, SOP based work-flow; Systematic, documented and effective controls of all study steps (from protocol to final report and archiving); Systematic, documented subcontractor audits (eg. analytical and clinical labs) to ensure reliability and compliance with highest quality standards;  Continuous and documented training to ensure that the staff is always qualified and up to date with the latest regulatory requirements. Additional services of the San Matteo Phase I Unit provide facility audits, EMA trial registration assistance to assess compliance with Client requirements and/or national or international quality standards.


8. Final Report
Fully integrated clinical study reports adhering to regulatory authority and ICH-GCP guidance are prepared. Clinical study reports with a comprehensive schedule, ensuring all aspects including integration, QC and review are produced in a timely manner. Final data is delivered in paper as well as electronic file format.

Data ultimo aggiornamento:  21/12/2011

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