Case Studies

Pharmaceutical

Pharma Data Management:

Pharmaceutical companies are focusing on compliance concerns because of their impact on all aspects of business operations. Efforts to comply with regulatory requirements must be supported by appropriate IT systems.

Features: The solution offers a safety data exchange which is hosted via a web application combining two different databases efficient exchange of safety information. PDM provides a customized component building an interface between clinical databases for online reconciliation of SAEs It offers a document solution for electronic capture of all submission documents related to drug safety. It enables efficient reporting of safety information in the form of a global offer tool and prior identification of hazardous signals.

Benefits: PDM is based on multi-tier web-enabled architecture for higher scalability and maintainability. It is customer-specific for alignment with clients' existing technology and infrastructure. PDM provides robustness to support company-specific business changes and also enables compliance with 21 CFR part 11, GCP and worldwide regulations on safety data management. It provides very high standards of data integrity and security