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designed to allow drug development teams – including clinical operations, medical and data management – to make more informed decisions.
Moore’s Law for pharma Saama’s bold vision is generating the life sciences industry’s very own Moore’s Law to drive down costs and decrease timelines. In 1965, Gordon Moore from Silicon Valley,
California, famously stated that the number of transistors in an integrated circuit would double every year, a phenomenon that came to be known as Moore’s Law. Collectively, the semiconductor industry has proved him right for several decades, dramatically increasing in power and decreasing in relative cost at an exponential rate. Saama has reimagined Moore’s Law for the
life sciences industry, leveraging AI-enabled technology to help pharma continuously learn from its own clinical trials and that of its peers, bringing recursive savings in both time and cost. Such shared learnings help reduce the safety and efficacy issues inherent in drug development, and can bend drug development’s cost curve while improving safety.
Modular software brings data to life Strategically unleashing clinical data across the pharma ecosystem for potential cost-savings and time gains can be a direct result of implementing AI. Though, initially, such applications may seem daunting, they are more easily managed than might be expected. “The promise and opportunity that AI offers
for transforming clinical trial business processes is practically limitless,” says Vasant Shetty, vice- president, corporate strategic transformation and execution at Saama Technologies. “LSAC can be leveraged by sponsors and CROs to provide a unified vision of clinical trial analytics while, at the same time, being flexible enough to provide modular software applications targeted to critical individual areas of need.” LSAC’s out-of-the-box solutions include:
operation insights clinical insights
risk-based monitoring
multiomics insights study planning insights regulatory insights
www.saama.com Outsourcing in Clinical Trials Handbook | 99
a master trials command centre a Covid-19 command centre a KPI studio
pharmacovigilance insights CRO insights.
Game-changers further transformation AI’s impact can be taken even further with unique AI-powered game-changing applications. Targeted areas of inefficiencies within the clinical development spectrum can be stripped away, transforming data access, efficiencies, costs and timelines. “By injecting AI into strategic points along the clinical development business process, we are fundamentally altering it for the better, from end to end,” says Jonathan Burr, senior vice-president, clinical platform strategy at Saama Technologies. “The implications are astounding: patient onboarding is streamlined, the time from last patient visit to database lock is reduced, data mapping is compressed to a matter of days and data cleaning can be reduced from one month to 24 hours.” LSAC’s game-changers include:
deep learning intelligent assistant (DaLIA) self-service data onboarding intelligent clinical data mapping smart data query
programming analytics and computing environment (PACE) clinical data hub (CDH).
AI, the FDA and the future The FDA recognises the promise of AI for safe and effective drug development. In 2018, the then- commissioner Dr Scott Gottlieb stated that, “AI holds enormous promise for the future of medicine. We’re actively developing a new regulatory framework to promote innovation in this space and support the use of AI-based technologies.” Like the rest of the life sciences industry, the FDA is now reimagining their traditional approach, based on the boundary- busting potential of AI. The path forward is clear. Utilised strategically, AI
platforms can offer an unprecedented vehicle for data aggregation that is agnostic to source, structure and existing clinical development infrastructure. Biopharma can ensure security, scalability and quality across the drug development life cycle, while gaining workflow efficiencies, such as automated alerts, collaborative task management systems and AI-powered predictive analytics. A new era of clinical development is being realised with AI, one that is indeed visionary, pioneering and innovative. ●
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