[INFOGRAPHIC] EDC System Data Privacy Compliance Considerations

In the leadup to regulations on data privacy, have you considered your EDC system data privacy compliance? Why is EDC system data privacy important? Pharmaceutical companies have been anxiously preparing for the General Data Protection Regulation (GDPR) which is coming into effect this May. In addition to GDPR, there are several clinical trial regulations that…

Clinical Data Transparency Programs: FDA vs EMA

In January 2018, the Food and Drug Administration launched a clinical data transparency pilot program aimed at making Clinical Study Reports (CSR) public upon approval. The pilot program begins with the recent approval of nine new drugs. The FDA is following in the European Medicines Agency (EMA) in trying to make clinical data publicly available,…