Egypt’s number one software solutions for the pharma industry

Vigipx is Egypt’s number one pharmacovigilance safety database, trusted with more than 90% of the market. It is a globally compliant ICH E2B (R3) system for the electronic processing of Individual Case Safety Reports, fully validated and hosted in a secure Oracle datacenter in Frankfurt, Germany.

• ICH E2B (R3) case processing and XML submission
• FDA 21 CFR Part 11, HIPAA and EU Annex 11 compliant
• A dedicated database for every client
• Signal detection, line listings and automated literature search

Insight Academy is our online learning platform, with pharmacovigilance and regulatory courses and educational videos written by the best experts in Egypt. Every course is developed and reviewed by former members of the Egyptian Drug Authority and World Health Organization experts, so new joiners and experienced staff learn the same high standard wherever they work.

• Pharmacovigilance and CTD training courses
• Developed and reviewed by former EDA members and WHO experts
• Built on the experience of more than 100 workshops
• Certificates of completion

Insight EDC is our electronic data capture system for clinical studies. Sites enter study data into electronic case report forms, and data managers review it, raise queries and resolve discrepancies in one place, so the data reaching analysis is accurate and complete.

• Electronic case report forms for each study
• Query management between sites and data managers
• Supports our clinical operations and data management teams

Dossier Hub is our regulatory affairs solution for building and managing registration dossiers in CTD and eCTD format. It keeps every module, document and version organised, from the first draft to the submission-ready file.

• CTD and eCTD dossier compilation
• One organised home for modules and documents
• Backed by our regulatory affairs team