Safeguarding Patient Privacy & Safety in Clinical Trials
Proper management of patient data has become an increasingly sensitive issue with the advent of Good Clinical Practice (GCP), 21 CFR Part 11, and HIPAA. In addition, the Food and Drug Administration (FDA) has raised the standard for what constitutes satisfactory pharmacovigilance.
Drug safety has consequently become an ongoing process which begins earlier and ends later in the drug development life cycle.
Contact us to discover how we can assist you to secure management of patient information, and aid in the quick identification of adverse events, critical to meeting the goal of optimal patient safety.