Security first
Auxiliis Pharma handles clinical trial information with best-in-class security: Linux based firewalls, daily data backup, recovery strategies in place, electronic audit trails, state-of-the-art virus protection.
Auxiliis’ computerised systems comply with the latest FDA guidance and 21 CFR Part 11.
Electronic Data Capture (EDC) /Electronic Case Report Form (eCRF)/Electronic Common Technical Document (eCTD)
§ Deployment of the EDC system
§ ICH-GCP and 21 CFR Part 11 compliant
§ EDC process consulting
§ "Translating" protocol and/or sample CRF pages into an EDC structure
§ Defining edit checks and manual checks for the eCRF
§ eCRF implementation, testing, validating and documentation
§ Setup and validation of lab data import and randomisation procedures
§ Preparation of trial specific training worksheets, training logs and certificates
§ User training and help desk
§ Additional data management services:
o Creation of data handling manual
o Regular lab data import
o Database lock and documentation
o Coding and classification process
o SAE reconciliation
Information Technology
§ IT systems are validated
§ Secure databases, daily data backup, disaster recovery strategies in place
§ Internet and email policy