Throughout the clinical trial process and into the commercial market, Clinlogix provides safety and vigilance services for pharmaceutical and medical device products. Our in-house team of safety specialists combined with state-of-the-art technological tools drives visibility into your data and supports you throughout your product’s life cycle.
As an Oracle Silver Partner, Clinlogix provides services through Oracle Argus, the industry’s gold standard vigilance platform. We offer and support a flexible multi-tenant environment, giving you direct access to your safety data. With this flexible environment, you can choose Clinlogix safety management services, utilize your safety management team, or a hybrid of both.
- Oracle Argus hosting; low-cost access, secure safety data
- Post-market surveillance
- Serious Adverse Event (SAE) case processing
- Adverse event (AE) management and reporting
- Pregnancy report handling
- MedDRA coding of serious adverse events
- WHODrug coding of concomitant medications
- Study team training on Argus usage, pharmacovigilance, and medical device vigilance best practices
- Data Safety Monitoring Board (DSMB) coordination
- Clinical Events Committee (CEC) coordination