Welcome to the safety revolution.
The pharmaceutical industry is undergoing a transformative shift toward proactive, systematic safety assessments at the program level during clinical development.
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Drug sponsors now recognize the dual benefits of enhancing safety reporting quality and meeting FDA IND safety report requirements (21 CFR 312.32) while also seizing the substantial business advantage of aligning safety and efficacy monitoring.
Few, though, know how to successfully plan and execute an aggregate safety assessment strategy.
Our solution is simple
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We bring the safety experts and technical implementation experts all under one roof. And companies get the end-to-end solution they're looking for:​
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A tailored safety strategy that aligns their needs with rigorous safety science & FDA requirements.
A validated, pre-built platform for quick and secure setup from which to begin their safety assessment.
Interactive graphics and dashboards to assess new safety topics of interest as they arise in a clinical trial or program.
Tailored Safety Strategy + Technical Implementation
Interdisciplinary safety evaluation during clinical development follows a structured, two-phase process: First, a program safety strategy must be established, followed by implementing a validated technical solution.
Recognizing that each phase requires distinct, specialized skill sets, we align these elements to ensure your project achieves a compliant and cost-effective outcome.
Safety Strategy
Optimize your safety approach with the proven, industry-leading Aggregate Safety Assessment Planning (ASAP) Process. The ASAP process, proposed by the DIA-ASA Interdisciplinary Safety Evaluation (DAISE) working group, offers a thorough cross-disciplinary method for program-level safety planning. With each project you benefit from the hands-on expertise of Dr. Greg Ball, co-lead of the PHUSE Safety Analytics working group and a pioneer in the DAISE working group, who will tailor a cohesive safety strategy to meet your unique requirements.
Technical Execution
Your technical implementation needs a solid foundation, but time is of the essence. With your safety strategy in-hand, we deploy a pre-configured infrastructure equipped with essential safety assessment tools, stringent access control, dashboards, and user authentication. This strong foundationfacilitates the swift creation and integration of new graphics as new safety topics arise, allowing for efficient deployment and dissemination within your organization or to external stakeholders, such as regulatory bodies. The Cardinal Safety platform is developed and maintained by Wildfell Software, a team with a history of developing cutting edge, FDA-compliant software for the biopharmaceutical industry.
Interactive Safety Plots
Harness the power of interactive graphics to effectively communicate your safety data.
Some safety topics of interest are known in advance, while others are learned as you go. By combining our safety strategy and infrastructure platform, we ensure timely delivery of crucial safety graphics, keeping stakeholders informed as new safety insights emerge.
Trusted Leadership
We bring together the expertise you need to support your aggregate safety assessment strategy in one established team, readily available on demand. This ensures you receive comprehensive support whenever you need it.
