Clinical research and drug development accelerated via analytics

SAS life science analytics help contract research organization Gunvatta expedite clinical trials and FDA reporting 

Bringing life-changing therapies to market requires pharmaceutical companies to efficiently design and run clinical trials, gather and analyze massive amounts of data, and manage a complicated regulatory review process. SAS, a leader in clinical research analytics, delivers powerful technologies to support the life sciences industry – including machine learning, AI and analytics for IoT – through the SAS® Life Science Analytics Framework on Azure.

The advanced analytics platform  – a single, open, cloud-native statistical computing environment for clinical trial analysis and submission – helps pharmaceutical companies navigate the heavily regulated world of clinical research analytics and bring new therapies to the world faster.

Delivering the power of analytics in the cloud

From drug discovery to regulatory approval, developing a new medicine can take over a decade with a price tag in the billions. The clinical research required to achieve approval from the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulatory authorities involves massive amounts of data that can be difficult to manage, share and analyze, creating delays that affect patients’ well-being.

The cloud-based SAS Life Science Analytics Framework on Azure features an integrated and collaborative environment to manage and analyze clinical trial information as well as deliver trial results for the FDA and other global regulatory agencies’ review. With the analytic solution, life sciences organizations can extract valuable insights from clinical data, mitigate risk, increase efficiency, and speed time to market for lifesaving pharmaceuticals.

Helping pharma accelerate clinical research

“The primary goal is to get drugs approved so that they can reach patients,” said Bhawna Goel, CEO of Gunvatta. “The faster you can do that, the greater benefit for the patient and to help save lives.”

Gunvatta USA, Inc., a contract research organization (CRO) headquartered in Washington, DC, helps clients collect, manage, analyze and visualize the terabytes of clinical and healthcare data produced by pharmaceutical and biotechnology companies, hospitals, and provider groups.

With the SAS Life Science Analytics Framework, Gunvatta has modernized the way it approaches clinical trials. The CRO helps life sciences organizations reduce risk with secure data access, ensure data and results are validated, maintain an audit trail, and report their data to health authorities like the FDA.

“The biggest advantage of the SAS Life Science Analytics Framework is that the analytics platform is cloud-based,” said Goel. “I feel like SAS has jumped 15 to 20 steps ahead of where the market is.”

For more about Gunvatta’s experience, see the customer story Helping pharmaceutical companies bring new therapies to the world faster using analytics for life sciences.

Developing cutting-edge clinical research tools

SAS life science experts will attend the DIA Global Annual Meeting this week in Chicago to share next generation approaches for driving excellence and innovation in clinical trial operations.

At DIA, SAS will preview SAS Clinical Enrollment Simulation Cloud – a cloud-native, solution based in SAS^® Viya^® 4 – that enables life sciences and contract research organizations to simulate the outcome of the complex clinical trial enrollment process in a virtual world, resulting in faster, more strategic clinical trial enrollment plans.

The new SaaS offering – available later this year on the Microsoft Azure Marketplace – uses a powerful discrete event simulation analytical engine to model the clinical trial enrollment process as it evolves over time, facilitating improved insights to guide enrollment strategy and meet contracted patient targets.

“SAS Clinical Enrollment Simulation Cloud is highly differentiated from traditional methodologies for predicting trial enrollment,” said Jim Box, Life Sciences Principal Data Scientist at SAS. “The technology helps life sciences organizations reduce timelines, minimize costs, and gain greater insight to inform clinical enrollment planning and rescue.”

Modernizing clinical trials for the future

While the current clinical development research model can be an obstacle to the creation of safe, cost-effective therapies, the COVID-19 pandemic and other events set the stage for disruption in clinical trials.

“The silver lining of the pandemic for the life sciences industry is the acceleration of digital transformation and modernization of clinical research,” said Simon Tilley, Health and Life Sciences Product Director at SAS. “We experienced widespread adoption of innovative approaches, such as decentralized clinical trials for the development of new vaccines.”

“While the business benefits of modernizing clinical research include significant cost savings, efficiency improvements, accelerated time to regulatory approval and faster time to market, it is patients who stand to gain the most from clinical trial innovation.”

For more about clinical trial modernization and transformation, see the SAS white paper Decentralized Clinical Trials: From Evolution to Revolution.