Our partnership with you: consistent compliance with your requirements

This Department is dedicated to a partnership with you in order to meet all your requirements. In this respect, we are in charge of:

 DATA ENTRY

• In-house data entry
  - immediate alarm in case of problems
  - possible emergency processing

• Independent double data entry
  - the second operator is uninfluenced

• Teams led by managers
  - who arrange for recruitment and training
  - who test data-entry programs before full-scale production
  - who manage data-entry agreements and supervise their implementations
  - who plan activities
  - who are Sponsor interface for the circulation of documents

• Quality Assurance checks of Data Entry
  - maximal error rate of 1/1000.

DATA MANAGEMENT

• All decisions are made with the Sponsor
  - validation plan review
  - correction request review
  - definition of authorized corrections to the Data Manager
  - frequent correction request review
  - discussion of questionable data

• All decisions made are documented E amendment to the data validation plan
  - amendment of authorized corrections to the Data Manager
  - email
  - Data Management report
  - audit-trail before inclusion of correction requests

• Implementation of the DataBase
  - CRF annotations
  - Database on Clintrial 4.1, 4.2 or 4.3 or SAS v.8

• Data Verification Programs
  - in PL/SQL on Clintrial 4.1, 4.2 or 4.3 or SAS v.8
  - validated using a battery of tests verifying that any reportable abnormality leads to a correction request

• Correction Requests
  - are implemented as data are being entered
  - are reviewed by the Data Manager together with the CRF before being printed
  - may be provided on NCR paper or pdf file
  - message adaptation by the Data Manager
  - a tracking file is supplied for each batch.
  - responses are processed by the Data Manager and verification programs are re-run immediately
  - data changes are audited.

• Medical Coding
  - is carried out by a physician
  - using standard dictionaries, including MedDRA
  - as data are being entered
  - information requests from the Coder to the Investigator are incorporated in the program correction request procedure.

• Medical Data Review
  - is carried out by a physician
  - as files are being completed
  - checkpoints are determined with the Sponsor
  - requests resulting from the Medical Data Review follow the same procedure as for other correction requests.

• External Data
  - are loaded at a rate defined with the Sponsor
  - correction requests are referred to the person who can provide an answer, i.e. either the Investigator or the laboratory.

• Preparation of DataBase Freeze
  - verification of overall consistency
  - reconciliation with the Drug Safety DataBase
  - coding review by the Sponsor
  - detection of any protocol deviations during the trial procedure
  - data presentation at the Data Blind Review