POST-MARKETING SAFETY SURVEILLANCE

Pharmacovigilance is all about the unexpected - planning for it, recognizing it, analyzing it, minimizing it. Sentrx helps companies focus on the unexpected. Our technology-enabled post-marketing safety solutions bring structure and standardization to adverse event reporting, making signals easier to identify.

SafetyTrak® Post-Marketing Safety is a turnkey solution with all the functions of a drug safety department. By combining our global Safety Response Centers with Web-based technology, we offer a modular solution to standardize the collection and management of spontaneous adverse events, product complaints and medical inquiries. Sentrx provides the following services:

• Response to medical inquiries and product complaints
• Initial adverse event data intake
• Case data entry into client pharmacovigilance system
• Investigation and follow-up, including active query
• Analysis and medical review
• Preparation of MedWatch, CIOMs and periodic reports for submission to regulatory agencies
• Literature Review
• Safety System Hosting

Sentrx begins every safety surveillance engagement with initiation activities where we develop working practices that connect our SOPs with yours. Our exclusive CaseTrak™ Conductor, a module of the SafetyTrak® Technology Suite, is configured to track each adverse event case through the process and eliminate bottlenecks.

Companies with established pharmacovigilance departments can take advantage of our intake and active query capabilities. We free your staff to evaluate post-marketing safety information rather than gather it with our deliberate, documented pursuit of adverse event case details. Our flexibility, along with our experience with most commercially available pharmacovigilance systems, allows you to integrate Sentrx into your workflow to perform these sub-processes.

Sentrx SafetyTrak® Post-Marketing Safety can help your company:

• Accelerate development of a safety surveillance program
• Meet regulatory demands with minimal increases in headcount
• Leverage pharmacovigilance expertise

For more information, download these documents:

SafetyTrak® Post-Marketing Brochure
SafetyTrak® Post-Marketing Case Study