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Active Safety Analytics for Pharma (ASAP)

Fact Sheet Solution Brief

Improve pharmacovigilance using FDA-recommended active safety surveillance

Pharmacovigilance professionals can now use real-world evidence from electronic medical records and insurance claims to search for safety signals. This type of active surveillance puts the power of the FDA’s Sentinel Initiative into pharma’s own hands.

Developed through a collaboration with Gilead Sciences, ASAP leverages the FDA’s Sentinel Common Data Model and TreeScan methodology for detecting safety signals. The TreeScan models were adopted to various study designs with scientific advice from Dr. Robertino Mera, Executive Director, Epidemiology, Gilead Sciences, and Dr. Judith Maro, Operations Lead of FDA Sentinel Operations Center, through a collaboration with the Reagan-Udall Foundation for the FDA.

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Healthcare Claims

EMR

MLCCS Tree

GPI Tree

Governance • Curation • Harmonization Orchestration • Unified Data Model • Metrics Ad-Hoc Reporting • Conversational UX

Outcomes

 

Active Safety Surveillance

Until now, sponsors have only been able to rely on voluntary, spontaneous reports and observational studies to understand a drug’s safety profile after it reaches the market. Reporting is limited by personal judgment, and any reports that do come in remain isolated data points in a patient’s life that can’t be used for follow-up or continued surveillance.

 

Drug/Outcome Exploration

ASAP is an advanced analytics engine that can identify new and unexpected safety signals based on real-world data from hundreds of millions of patients. The solution enables pharmaceutical companies to track individual experiences with drugs over an extended period of time and explore potential causal relationships between drug/outcome pairs.

 

Competitive Product Monitoring

ASAP allows companies to explore the safety profiles of any drug that’s currently in the marketplace.

 

Regulatory Response

Proactive safety monitoring makes it easier to respond rapidly and comprehensively to any regulatory requests related to potential safety concerns.

Helping Our Customers Succeed with Active Safety Analytics

 

Gilead’s commitment to advances in pharmacoepidemiology is reflected in our partnership with Saama to create ASAP to push the boundaries of safety for new and existing medicines,” said Dr. Mera. “ASAP can effectively complement existing spontaneous safety surveillance capabilities to provide Biotech and CROs with a comprehensive safety surveillance framework that will help enable the next generation of life-changing medicines.

Robertino Mera, M.D. Ph.D., Executive Director, Epidemiology Gilead Sciences

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To arrange a demo and learn more about how you can set up ASAP as a secure subscription service in the cloud, contact us!

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Terms & Conditions

By inquiring about Saama’s Database Lock in a Day, you agree to be contacted by Saama and to allow Saama to use, maintain, store, and protect your personal data in accordance with our Privacy Policy.

Eligibility details are for informational purposes only. Saama, in its sole discretion, will determine your eligibility based on the information you disclose as part of the intake process. If Saama determines that you are eligible to participate, you will be notified by separate email. Eligibility depends on certain criteria, such as the size of your company, the types of clinical trials you sponsor, and the number of patients in–and stages of–your current clinical trials.

By completing the request form, you represent that you have authority to proceed on behalf of your company. Should you agree to participate, you agree to reasonably cooperate with Saama in following the guidelines and procedures required for integrating, standardizing, and analyzing your data. Participation requires the use of our Smart Data Quality application, a technology-agnostic AI engine that sits on top of your current infrastructure. The application can be used immediately, and you’re only charged for the services you use based on a predetermined estimate.

Information you share with Saama during your participation may be anonymized and/or aggregated, and made available publicly in Saama marketing materials. This information may include: types of systems and processes involved, types of departments involved, and size and regional location of your company. Such information will never be directly associated with you, nor will you or your company be identifiable without express written permission.