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Active Safety Analytics for Pharma (ASAP)

Improve pharmacovigilance using FDA-recommended active safety surveillance.

Saama’s Active Safety Analytics for Pharma (ASAP) is an advanced analytics engine that can identify new and unexpected safety signals based on real-world data (RWD), such as healthcare claims and electronic medical records (EMR).

ASAP is the first viable, validated active safety analytics solution for the Life Sciences industry. This powerful data science solution mirrors the capabilities developed by the FDA through the Sentinel Initiative and empowers drug developers to:

  • Actively identify safety concerns during routine safety surveillance
  • Understand the safety profiles of competitive products
  • Identify all drugs associated with a specific outcome
  • Explore potential causal relationships between drug/outcome pairs
  • Respond rapidly and comprehensively to regulatory requests and potential findings

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.

Active Safety Surveillance Greatly Enhances Your Safety Surveillance Efforts

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.

With the active surveillance offered by ASAP, using real-world data from hundreds of millions of patients, sponsors can proactively track individual experiences with a drug for an extended period of time. As data from vendors like IQVIA and Optum is already scrubbed of all identifying markers, patient data privacy is maintained while safety surveillance is greatly improved.

Get Started Today

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

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.