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Are You Ready For Sentinel?

FDA Continues to Support the Sentinel Initiative

An October 1 announcement of FDA’s funding of $220 Million to the Harvard Pilgrim Health Care Institute for the next phase of FDA’s Sentinel System brings continued focus on FDA’s commitment to evaluating Real World Evidence (RWE) for informing prescribers and patients about product safety. Key to the Sentinel System is a network of electronic medical records that can be utilized rapidly to address issues of concern.

UBC has been at the forefront of the RWE arena for the past 15 years and has developed methodological depth as well as automated tools that generate rapid insights from real world claims and EMR databases. The key to validated, automated evaluation and response is our SᴁfetyWorks® tool that allows for analysis without programming. Our comprehensive solution includes:

Ø Global Database Feasibility Studies

o  In-depth review of data elements and literature

o  Understanding data strengths and limitations

o  Direct discussions with data vendors

o  Data agnostic – recommendations based on database ‘fit for purpose’

Ø Protocol Development – Designing Post-Marketing Safety Studies

o  Cumulatively, over 100 years of experience developing the appropriate study design to provide meaningful results

o  Proven track record of developing protocols accepted by the EMA and FDA

Ø Study Implementation

o  Customized studies and/or automated analytics according to the approved study protocol

o  Established relationships with US and European data vendors

o  Use of formal SOPs for study conduct and validation of results

Ø RWD automated software for signal identification and refinement

o  SÆfetyWorks® analytics software leverages RWD for performing signal refinement and evaluation to supplement signal identification based on spontaneous case reports.

o  Aligned with FDA’s Sentinel Initiative methods of signal identification and evaluation.

Researchers using RWE to evaluate product safetyTake steps now to partner with a patient-support services company with extensive RWE safety experience including in signal detection and analyses. Contact UBC to see if you are positioned for Sentinel and to learn more.