Safety Systems
Our Safety Systems Services run the gamut, from implementation, compliance, upgrade management, and maintenance through the complete set of reporting requirements including the latest developments in e2b (and its future cousin, HL7). We’re set up and designed to help you if you’re changing within existing systems or embarking upon your first move into a third-party party solution. Our Sentrx TSG Safety Systems personnel have managed all of the major systems, including Argus™ Safety and ArisG, as well as Empirica™ Trace. If you’re operating an internally developed system and looking at your options, feel comfortable knowing we’ve been there as well.
For those with a current system position, our expertise can be helpful numerous ways, from managing an upgrade to adding a component such as ECSM, integrating signal tools, or upgrading workflows. Our reputation here is stellar with a proven track record for on-time, on-target implementations that deliver a case-ready system. Of course, as a major provider of adverse event management services, we know how critical it is to not only meet the “go live” dates, but to also meet the “audit-ready” requirements imposed by CFR21 Part 11 and all of the related regulated needs.
For those just starting out, perhaps taking over their data from a CRO, partner, or product acquisition, you can relax. We know how to guide your selection process, informing your decision-making about total cost of ownership, user experience, new user adoption, and how the commitments of the suppliers and their road maps will fit with your strategic business needs. We enjoy excellent relationships with critical business partners, Oracle and PhaseForward, ensuring you get all the information needed to make an excellent, confident decision.
It’s important to understand, though, that we can play a couple of different levels.
Basic level is all about your user requirements, conventions, and configurations and other essentials such as infrastructure and systems architecture analysis, support requirements, hardware recommendations, remote access solutions, analysis of integration need, and of course, validation needs.
A higher level, though, adds another layer of thinking to ensure your safety system and the supporting components will support the organization’s strategic needs. We’ll leave it here with this critical question: if the strategy of your organization is to successfully develop compounds through Phase II, then seek out-licensing partners, which components of a drug safety system may be more critical to your organization’s needs?
In this arena, you need Sentrx, an expert. We’re your translator, your navigator and your engineer—transforming the promises of a COTS solution into a flawless system you can adjust to fit your needs as the business ebbs and flows. Our experience makes us at ease with the supporting safety technology (in business intelligence, for example) and how it can be configured and organized to drive critical functionality such as access, security, workflow reporting, and data management.
Talk to Sentrx TSG; in safety systems, we simply are the best.
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Wade Weinzetl |
