Drug Safety

Put your safety data in practiced hands

Drug safety is too important to entrust to underqualified teams or unpredictable models. At inSeption Group, our seasoned drug safety professionals deliver compliant, scalable, and cost-efficient safety solutions—built for today’s complexity and tomorrow’s regulatory demands.

Senior experts. U.S.-based. No offshoring.

Our Drug Safety team is composed entirely of US-based specialists—each with 10+ years of hands-on experience. This ensures:

  • Immediate accessibility
  • Full accountability
  • Consistent coverage across time zones

With company turnover under 6%, your team remains intact across the full lifecycle of your program—unlike traditional CROs with 25-30% attrition.

Built-in compliance for what’s coming next

We don’t just meet regulatory expectations—we plan for them. With new safety reporting regulations expected in April 2026, our team stays ahead of evolving guidelines so your program is always ready for what’s next.

Flexible pricing. Predictable costs.

Traditional unit-based models drain budgets without adding value. Our customizable pricing approach delivers cost control and transparency—no surprise line items, no nickel-and-diming.

Oracle® Argus Safety Database Power Users

With deep expertise in Oracle® Argus, we support full configuration and maintenance, real-time data outputs, and seamless safety data migration, with or without data cleaning, from legacy safety systems to our cloud-based Argus safety database.

Process built for operational and cost efficiency

Our robust experience in design, implementation and continuous process optimization ensure that we build you a safety system that is cost efficient and scalable to meet your future safety needs.

Communication and collaboration

In drug safety, collaboration isn’t just a buzzword—it’s an essential component that can impact patients and the success of your development program. We manage collaboration and communication between cross-functional global stakeholders to ensure timely and consistent messaging of safety-related information.

Global Drug Safety Solutions and Services

  • Configuration and maintenance of the Oracle® Argus safety database
  • End-to-end SAE/AESI case processing with or without Medical Review
  • Expedited reporting to regulatory authorities and Central IRBs/ECs
  • Cross-reporting to development partners and third-party vendors
  • Custom Safety Management Plan development with real-time optimization
  • SAE reconciliation between Argus and EDC platforms
  • Aggregate safety reports: DSUR, Annual Safety Report, and more
  • Temporary safety staffing for planned or unplanned long-term absences
  • Accelerated vendor transition and implementation support

Let’s make safety a strength

Our drug safety approach is proactive, personal, and built for scalability—with the senior oversight your product deserves and the flexibility your timelines demand.

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Schedule quality time today.