Safety Sphere, LLC began offering customized drug safety and pharmacovigilance consulting services in 2013.
We are a women-owned business with over 20 years of professional experience in pharmaceutical clinical drug safety and pharmacovigilance services.
Understanding and staying up-to-date with international and FDA drug safety regulations is the key to our success.
In many cases, our clients see us as their drug safety team.
We are ready to use our experience to support you with your drug safety and pharmacovigilance needs. Contact us today.
What Are Our Core Values?
Safety Sphere, LLC gained our expert knowledge through hands-on drug safety experience. We have a unique understanding of the drug safety team’s needs and a clear direction of pharmacovigilance requirements.
Our team is committed to these core values.
✔ Honesty and Transparency
✔ Patient Safety
✔ Collaboration
✔ Study Integrity
We Support Drug Safety Teams
We collaborate with small biotechs to moderately-sized pharmaceutical companies and clinical research organizations (CRO).
Our knowledge spans across all phases of drug development along with the management of global components.
Safety Sphere has accomplished the processes below for other companies.
And we can do it for you, too.
Let us help your drug safety team achieve its goals.
Drug Safety and Pharmacovigilance Department Development
✔ Built departmental capabilities from 1 staff member in early Phase 2 of clinical development to a 10-person team
✔ Rescued an established drug safety department that experienced a sudden staff turnover; including providing temporary staffing, enhancing efficiency through process refinement, and executing a safety database upgrade and validation
✔ Managed a global Phase 3 trial in critically ill patients; including submission of over 100 expedited reports to international authorities
✔ Trained safety team members on SOPs and reporting regulations
Pharmacovigilance Process and System Efficiencies
✔ Developed templates and tools that facilitated FDA compliance with safety SOPs and regulations
✔ Developed DSUR and periodic safety submissions
✔ Transitioned departmental operations to paperless SAE processing
✔ Managed and refined adverse event processing for high acuity marketed products
✔ Created and implemented safety exchange agreements with corporate partners
FDA Regulatory Audit Preparedness
✔ Participated in multiple successful regulatory authority audits, including commercial and clinical trial products
✔ Maintained extensive training and knowledge of Good Clinical Practices, ICH, and FDA regulations
✔ Conducted system validation for FDA’s 21 CFR Part 11 compliance
Drug Safety Associates and Drug Safety Specialist Support
✔ Managed MedDRA and WHO Drug coding for safety and clinical databases
✔ Provided extensive narrative writing services for safety cases and clinical study reports
✔ Developed and managed Safety Oversight & Risk Management Meetings for aggregate reviews & analysis
Drug Safety Database Support and Vendor Selection Assistance
✔ Installed various drug safety databases
✔ Validated ARISg databases as both a SAAS and On-Premises deployment
✔ Assisted with safety database vendor evaluation and selection
✔ Participated in vendor contract negotiation
✔ Configured drug safety database systems.
✔ Implemented company-specific drug safety database guidelines.