Fondazione Salvatore Maugeri and Ethical eClinical Solutions

Fondazione Salvatore Maugeri logo

The Salvatore Maugeri Foundation (FSM) was founded in 1965 to support the activity of the Institute of Occupational Medicine of the University of Pavia.

Cardiovascular Physiopathology laboratory in Lumezzane (Italy) and CRU operates as project management and clinical research organization for sub-studies sponsored by the french I.R.I.S (Institut de Recherches Internationales Servier).

SIGNIfY - BIOMARKERS SUB-STUDY


Maugeri Signify

SIGNIfY (Study assessInG the morbidity–mortality beNefits of the If inhibitor ivabradine in patients with coronarY artery disease).

The project  is conducted  by Italian Fondazione salvatore Maugeri laboratories in Gussago for the Swiss Medical Trials Analysis for the sponsor of the main clinical trial and the sub-study, the Institut de Recherches Internationales Servier (I.R.I.S).

The study involves a big number patients already enrolled in international sites for the main study and recruited for analysis. 

The Signify study is the logical consequence of the previous Beautiful study and the customer and its sponsor decided to use the E-CRF platform after the first experience with the Beautiful sub-study.

The Ethical e-Crf Cloud Solution for the specific project includes the CTMS software package aiming to be the reference database for the sub-study.

Together with the CTMS package the following packages and modules are provided and customized when required:

  • Remote Data Entry and Built-in controls and alerting procedures,
  • Double Blind Data Entry and discrepancy management,
  • DCF and Query Management,
  • Filtering and Exportable Audit Trail logs,
  • Standard Data export for biometric and statistical analysis.
  • Custom Data Transfer Protocol respecting the legacy third party environments,
  • GAMP 5 and ISO 27001 requirements from the main sponsor  I.R.I.S (Institut de Recherches Internationales Servier),
  • Validation documentation package.

Servier

Servier, founded in 1954, is the first independent pharmaceutical group. We are present in 140 countries, with more than 21000 employees, including close to 3000 in R&D.

BEAUTIFUL Echo-NT - proBNP Sub-study


Maugeri Beautiful

Beautiful (morBidity-mortality EvAlUaTion of the lf inhibitor ivabradine in patients with coronary disease and left ventricULar dysfunction)

The project, an ancillary study of a Phase III clinical trial, is conducted  by the italian Fondazione salvatore Maugeri laboratories in Gussago and Ferrara for the french sponsor, the Institut de Recherches Internationales Servier (I.R.I.S).

Beautiful Echo/NTproBNP Substudy is part of a Phase III study and consists of a number of Echocardiography examination (ECHO) and drawing performed in more then 100 laboratories all around the world and need to respect a scheduling period.

This trial involves the collection of medical reports, samples and ECHO recordings from the participating centers, with automatic import procedures integrated with complex data entry and quality control procedures.

The Ethical e-Crf Cloud Solution integrates the following software packages and modules:

  • Logistic management: sample reception and quality control tracking,
  • Echo data import from laboratories analysis tools,
  • Quality control specific funtionalities and criteria
  • Specific quality control profiles
  • Alghrytms for the creation of batch of data for analysis following blindness strict criteria;
  • Custom data export procedures for biometric and statistical analysis as required from the main sponsor (I.R.I.S)
  • Validation documentation package 

Servier

Servier, founded in 1954, is the first independent pharmaceutical group. We are present in 140 countries, with more than 21000 employees, including close to 3000 in R&D.