Pharmacovigilance

Argus Safety™database complies fully with the validation, MedDRA coding and security standards defined by ICH E2B and the FDA’s 21 CFR part 11

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Complete Software System for Pharmacovigilance

Argus Safety™ is a complete pharmacovigilance software system, providing tools for ensuring regulatory compliance on a global basis and is consistent with ICH initiatives. Argus Safety™ supports both premarketing and postmarketing pharmacovigilance business processes.

Argus Safety™Validation and Security

Our IT team provides a validated and 21 CFR part 11-compliant environment with the highest standards of data security and systems validation. In 2003, ACCOVION validated Argus Safety™ according to GAMP level 4. As with all our clinical systems, Argus Safety™ is hosted in an ISO 9001-certified data center with the highest security standards according to FDA guidelines, providing maximum physical data security together with backup and recovery procedures. The data center is operated by Triaton GmbH (www.triaton.com), a leading IT service provider in Europe.

Global Regulatory Reporting

ACCOVION has configured the Argus Safety™ database with customized rules for expedited safety reporting. These rules are thoroughly validated and are flexible enough to meet the worldwide regulatory requirements. Using this setup, ACCOVION can easily submit expedited reports to regulatory authorities, investigators and, in the EU, to central ethics committees. Argus Safety™ provides expedited reports on all forms in common use:

• The CIOMS-I form
• The American FDA MedWatch 3500A form for drugs
• The American VAERS form for vaccines
• and several other forms used in major European countries

We also provide safety data suitable for the familiar American IND annual reports and the new European annual safety reports (required from May 2004 by the EU Clinical Trial Directive 2001/20/EC).

Electronic Safety Reporting

The pharmacovigilance system at ACCOVION is fully ICH E2B compatible.

Coding options with Argus Safety™

The standard setup in Argus Safety™ includes coding with MedDRA® and WHO data dictionaries. We have the most current versions of these dictionaries available, together with earlier versions and other dictionaries to suit all customer requirements.

Throughout ACCOVION, we use a single system for managing coding dictionaries, synonym tables and code lists, with interfaces to Clintrial®, Oracle® TMS and SAS®. We can extract any version for coding and data analysis and can use any combination of dictionary and synonym table, which also affords maximum flexibility to suit our customers’ requirements.

Quality is built-in

ACCOVION has implemented extensive quality control at all workflow steps in Argus Safety™, from data entry onwards, to ensure maximum data quality and consistency. Our workflow model guarantees regulatory reports of highest quality.

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