Current disruptions are increasing demand for business intelligence and causing sponsors and CROs to rethink their dependence on traditional business processes.
COVID-19 has disrupted clinical trials in many ways. Patients aren’t getting to sites. CRAs aren’t traveling. Physicians and medical staff aren’t as available to support trials. The FDA has issued emergency guidance for the pandemic, urging sponsors and CROs to find alternate ways of ensuring patient safety or give up their studies altogether.
A risk in a disrupted study could be something as straightforward as having patients with previously identified adverse events (AEs) who can’t be properly monitored via standard operating procedures. Under these circumstances, how can clinical researchers be sure that an AE won’t become a more severe adverse event? How can researchers and clinicians identify and care for the most critical patients? How can they quickly assess and compare protocols and make the best decisions given disruptions in standard processes?
Data Technologies Can Minimize the Impact of Disruptions
Sponsors and CROs—not to mention patients—can benefit from an intelligent system that captures AEs, alerts researchers when target thresholds are breached, and contextualizes and curates information to ensure that the right patients are prioritized. A smart system drives collaborative workflows that facilitate proper follow up and compliance, through visibility and information sharing across study stakeholders.
Sponsors and CROs with intelligent solutions in place prior to the coronavirus outbreak have been better prepared for the resulting disruptions. They can identify the most critical needs of their trials, mitigate the most critical risks, and are best positioned to re-engage their studies aggressively when trials resume more typical routines.
At Saama, we offer a complete and integrated business intelligence system that aggregates and contextualizes data through AI-enabled data pipelines, so researchers can get the insights they need to prioritize and resolve critical data gaps in real time. We offer a complete suite of operations and clinical solutions, risk and safety solutions, and remote monitoring capabilities. You can choose the complete portfolio of applications, any subset of those, or use your own applications on our flexible, secure data platform.
Use This Disruption as Your Wakeup Call
Now more than ever, sponsors and CROs are realizing how important it is to stay at the forefront of technological innovation. It drives me crazy that an industry devoted to saving and improving lives has been bogged down in time-consuming, error-prone manual processes for so long—and is so exposed to the additional risks of the pandemic—especially when it doesn’t have to be!
Business intelligence and analytics have been around for a long time. Data science is improving every day, with innovations in machine learning, complex event processing, data mining, and predictive analytics that will revolutionize our industry.
AI and machine learning are trendy buzzwords that many folks in the industry are using. Most, however, are just using the buzzwords and not the technology. At Saama, we are applying artificial intelligence and machine learning at the data aggregation layer of our technology stack, and in the application and UI components of our solutions. This is enabling rapid data integration, improved data quality, contextualized information for clinicians and ops managers, and smart interfaces that enable fast and easy access to meaningful information.
These solutions are important decision-making tools in all trials, and have become even more critical in today’s pandemic impacted world. The new normal will likely be characterized by more virtual trials and more patient-generated data. The volume of real-time data will increase exponentially, and new models of data review and validation will emerge.
This is an exciting time to be in pharma. Sponsors and CROs will need big data platforms and speed-sensitive, smart applications to navigate their trials today and return them to a success path as the economy revives.
Will you be ready?