What Makes Us Different?
Many organizations provide templated services with the expectation that your team needs to adapt to their format.
Safety Sphere’s drug safety and pharmacovigilance services are adaptable to each of our client’s unique needs.
We Offer Custom Drug Safety and Pharmacovigilance Services
Here are a few examples of our custom offerings:
✔ SOP development
✔ Establishing best practices
✔ Creating form templates
✔ Project Management
✔ Workflow Solutions
We also can support you with these pharmacovigilance solutions:
✔ FDA Regulatory Compliance / Audit Preparedness
✔ Gap Analysis
✔ Drug Safety Departmental Structure and Set-Up
✔ Drug Safety Training
✔ Drug Safety Technology Integration
✔ Individual Case Safety Report Processing
✔ Clinical Study Reports / Periodic Submissions
✔ Signal Detection and Surveillance
✔ Design and Implement Drug Safety Overview Meetings
Contact us today to find out more about our services.
We Can Help You Proactively Detect Safety Signals
Drug safety and pharmacovigilance teams face a difficult task. The team needs to meet drug safety regulations in a thorough, accurate, and timely manner.
Plus, the pharmacovigilance team needs clearly defined processes for the reporting and review of safety data. This is a critical task for proactive signal detection.
The team, often with minimal staff, are expected to maintain compliance in this highly regulated area.
Safety Sphere, LLC consultants offer drug safety and pharmacovigliance services that will facilitate the development of your company’s operational processes to identify, evaluate, and manage safety signals.
We are here to support your internal drug safety and pharmacovigilance team. Let us show you what we can do for your company…you will be happy you did.