Facing the challenges of COVID-19, health and pharmaceutical organizations globally are innovating and digitally transforming clinical research analytics—from getting trials up and running, to modernizing trial designs, to delivering new therapies and vaccines faster. Supporting clinical-trial modernization is the updated SAS® Life Science Analytics Framework, which helps transform data into life-changing insights and deliver better, safer therapies to patients faster in a highly regulated landscape.
“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.”
SAS offered a demonstration of SAS Health and the updated SAS Life Science Analytics Framework during this week’s virtual PhUSE EU Connect conference.
A singular analytics foundation for clinical research
For decades, health and life sciences organizations have relied on the SAS Life Science Analytics Framework – 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. New functionality provides even greater efficiency:
• A seamless open-source integration with the ability to program in SAS, R or Python.
• Inclusion of study metadata and data standards enhancements for easier and more complete definition of study details.
• Automation of the development process for tables, listings and figures to ease tracking effort for clinical study report development.
• Addition of two-factor authentication for increased data security.
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, Vice President of Global Biometrics at Ferring Pharmaceuticals. “This foundational solution enables execution of modern trial designs and has the potential to support decentralized clinical trials,” Klein added.
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 Senior Research Analyst Nino Giguashvili 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.”[1]
Robust analytics transforming health and life sciences
“SAS is the only vendor with this breadth of experience and offering comprehensive solutions for both clinical development and real-world, observational data analysis, inclusive of data management, traceability and regulatory needs,” said Lambrecht. “With these updated solutions, we’ve built upon decades of our industry expertise to provide even more extensive capabilities to manage, analyze and visualize diverse types of patient data across the full drug development spectrum.”
Learn more about SAS industry-leading, innovative life sciences analytic solutions: sas.com/en_us/industry/life-sciences.html.