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The rapid development of IT technology has influenced the maturing of drug safety surveillance systems. In the eighties of the last century, storage and retrieval of safety data was the required function of a computerized information system for pharmaceutical companies. Most of the large companies custom-tailored their own computer-assisted database systems to meet their specific needs. These systems were primarily developed for data storage and subsequent regulatory reporting of single case reports. These in-house systems then allowed for single-case as well as for statistical data evaluation, increased the reliability of the data and enhanced systematic data structuring. However, most systems were at that time not specifically designed for the systematic early detection of new and unknown adverse drug reactions (ADRs) and for safety evaluation, today the main focus of pharmacovigilance.
With the implementation of tight regulatory pharmacovigilance obligations worldwide, initiated by ICH in the nineties, new needs for industry emerged: Proactive surveillance systems with signal detection features were demanded, the systems required compliance to legal regulations as handling the safety data became subject to regulatory directives and open to audit and inspection, electronic transmission of safety data from industry to regulators became near future.
Many companies were faced with the problem that their own system could not or not be easily adapted to these new GMP and GCP requirements. In most cases adapting or updating the existing database systems was not feasible and new systems meeting all new requirements had to be implemented. Setting up pharmacovigilance databases became even for large companies challenging as the IT requirements for signal detection and safety evaluation are very specific.
Meanwhile various sophisticated commercial database systems are available. They cover the wide range of regulatory reporting requirements, data storage and retrieval, and electronic transmission of data. However, they must be customized to meet the company-specific need to establish a high quality pharmacovigilance database system which allows for signal detection and safety evaluation.