ARIANNE provides complete safety services. We have proven processes and systems for managing reports of Serious Adverse Events for all our clinical trials within the United States or globally. Our investigators have access to dedicated medical personnel 24-hour-a-day via safety telephone services. Our team consists of experienced physicians, nurses, clinical data specialists with extensive years in drug safety management.
We provide:
- Customized safety plans
- Clinical and Post-marketing adverse event (AE) and Serious Adverse Event (SAE) management from initial data collection through regulatory reporting
- Written medical evaluations including narrative preparations, causality assessments, follow-up information from the investigational sites and when requested, recommendations for reporting to the various international regulatory agencies
- SAE reporting in an agreed format to your clients or to the regulatory agencies
- Expedited US and International case reporting
- Preparation and submission of Periodic Reports and Periodic Safety Update Reports to US meet Regulatory Obligations
- Safety database management
- Reconciliation with CRF
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