Products
One advantage of knowing safety and medical affairs as well as we do is this: we see the gaps, meaning specifically the gaps in solutions offered by the major system providers. Those gaps often translate into expensive, manual work streams, which is not at all consistent with our plans for delivering exceptional outsourcing. Since necessity is the mother of invention, we’ve invented several important tools, some of which we make available to you as stand-alone products.
EasyCode™, a unique and powerful auto-encoder for MedDRA version management
Designed by our team, EasyCode™ reflects the critical workflow steps needed to recode, including medical review. EasyCode™ automatically recodes the terms for which only the text has changed. We review the distinct LLTs that no longer have a full hierarchy match in the new MedDRA version and choose the appropriate replacement. EasyCode™ then automatically recodes the cases containing these LLTs. Sentrx also updates all datasheets and analyzes all pending periodic reports and period safety update reports (PSURs) for changes to MedWatch reports already submitted. Every MedDRA version upgrade is verified for accuracy and completeness, and thorough documentation of the effort is provided to our clients.
If your team is wrestling with MedDRA version management issues or contemplating how to quickly make conversions, give us a call so we can talk to you about EasyCode™.
RESPONSETRAK™ ADVISOR, a fully integrated response management tool
Our full service pharmacovigilance and medical affairs capabilities mean we completely understand the need to manage all events in an integrated manner. It’s more efficient; it leverages staff and systems and provides for a single-source solution. We created ResponseTrak™ to help our clients who want either a stand-alone response management tool or want to integrate it with our adverse event management savvies.
ResponseTrak™ Advisor manages the intake of and response to medical inquiries (MIs) and product complaints (PCs). A browser-based application built around personal work lists, it operates to continually update tasks as they flow to responsible personnel and are completed. This may include your team or ours.
It’s unique among medical information applications because it recognizes the link between MI/PC handling and adverse event management, so for our clients who need a complete end-to-end solution, ResponseTrak™ often represents an ideal solution.
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ResponseTrak™ ADVISOR At A Glance
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Low cost of ownership
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Client-specific customization available
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Verbatim capture
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Inquiry or complaint categorization
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Keywords knowledgebase
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Approved verbal and written responses to FAQs
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Pre-defined action steps for product complaints based on their categorization
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Auditable record
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Matrix Management SOPs and workflow fields
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James McGrath |
