Software company SAS has been supporting the drug and COVID-19 vaccine development as health and pharmaceutical organizations digitally transform their clinical research analytics. The update of the SAS Life Science Analytics Framework will help in accelerating clinical trials — from getting trials up and running to modernizing trial designs, to delivering new therapies and vaccines faster.

“Clinical development is at an inflection point with accelerated development for new therapeutics and vaccines for COVID-19, coupled with a move toward decentralized, virtual hybrid clinical trials,” said Mark Lambrecht, PhD, global director of the Health and Life Science Practice at SAS. “In our SAS Health product portfolio, we continue to invest in industry-leading analysis solutions for small biotech entities just getting started in clinical development to large pharmaceutical enterprises with thousands of users.”

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Singular analytics foundation

SAS Life Science Analytics Framework is a single, open, cloud-based analytics solution for clinical research, with embedded analytic tools, support for data standards and optional integrated analytic applications. SAS Life Science Analytics Framework 5.3 is designed to reduce development timelines and drive modernization of clinical trials, while ensuring regulatory compliance.

The updates include seamless open-source integration with the ability to program in SAS, R, or Python, and the inclusion of study metadata and data standards enhancements for easier and more complete definition of study details. It also includes the automation of the development process for tables, listings and figures to ease tracking effort for clinical study report development. The addition of two-factor authentication is to increase data security especially now that threat actors have been targeting anything related to the COVID-19 vaccine.

Ferring, a Swiss biopharmaceutical group, selected SAS as a long-term strategic analytics partner to support its mission. SAS helps Ferring deliver personalized health care solutions and optimize health outcomes by integrating pharmaceutical products with diagnostics, data, devices, education and support services.

“The SAS Life Science Analytics Framework, hosted and managed by SAS in a fully regulatory-compliant cloud environment, helps international virtual teams at Ferring and clinical research organizations (CROs) to access clinical data in the same way and continuously optimize working procedures,” said Bjarke Klein, VP of Global Biometrics at Ferring Pharmaceuticals. “This foundational solution enables execution of modern trial designs and has the potential to support decentralized clinical trials.”

Going beyond clinical trial data

Health care researchers and regulatory agencies like the US Food and Drug Administration (FDA) need a more comprehensive view of patients to make confident decisions about health care, drug approvals and policy. But clinical trial data, electronic health records, claims data and adverse event reports are only snapshots of patients at random points in time.

To provide real value, a holistic patient profile built with real-world data — or observational data collected beyond controlled clinical trials — is needed to achieve the greatest effect on health and wellness and to assess the safety and efficacy of new drugs and medical devices.

“SAS Health: Cohort Builder,” launching later this month, enables quick discovery and creation of patient cohorts for population health analytics, clinical feasibility analysis, safety and efficacy, and more.

“The COVID-19 pandemic has signified the value of real-world data to an unprecedented extent,” said Nino Giguashvili, senior research analyst of IDC Health Insights Europe. “Going forward, real-world data will become an indispensable source of evidence to inform regulatory decisions on future diagnostics, vaccines, and treatments beyond public health emergencies.”