Oracle
Articles
Advanced methodologies for signal detection in emergency-use cases (COVID-19)
November 29th 2022November 29th 2022 9 am CT |10 am ET | 3 pm BST | 4 pm CET Statistical signal detection is a crucial tool for rapidly identifying potential risks associated with pharmaceutical products. New methods for signal detection offer the potential to identify adverse reactions from vaccines and drugs earlier.
How CROs Are Leveraging Innovation to Accelerate Clinical Trials
November 17th 2022November 17th 2022 9 am CT |10 am ET | 3 pm BST | 4 pm CET Faced with an increasingly more competitive future CROs are spearheading of adoption of modern clinical applications to increase efficiency, enhance collaboration, and improve trial performance. Advancements in clinical trial processes have arisen as a result of cross-company collaborations amongst CROs and various industry stakeholders – constrained by time and compelled by regulatory compliance – to support broader industry-wide adoption of innovations.
How EU 536/2014 Will Revolutionize Global Clinical Trials
November 3rd 2022November 3rd 2022 9 am CT |10 am ET | 2 pm GMT | 3pm CET The way clinical trials are conducted in the European Union is undergoing major changes with (EU) No 536/2014. But just being compliant with the regulation should not be considered enough – forward-looking organizations are rethinking how technology can play an important part in bringing efficiencies to clinical trials, by reducing failures and driving operational changes beyond compliance.
Oracle and Cerner: A Leap Forward in Safety
October 18th 2022October 18th 2022 9 am CT |10 am ET | 3 pm BST | 4 pm CET Oracle’s market-leading safety software solutions provide highly powerful technology and algorithms for data mining. Combining Cerner Enviza’s real-world datasets containing de-identified, person-centric, longitudinal records offers a vast resource for expanding the potential of safety signaling.
Data Science, AI, and Machine Learning: The Path to Improved Safety
October 4th 2022October 4th 2022 9 am CT |10 am ET | 3 pm BST | 4 pm CET Managing drug, vaccine, and device safety has become increasingly challenging as companies are confronted with adverse event (AE) caseloads rising as much as 30-50% per year. Constrained resources and limited qualified outsourcing options have created the need to streamline the pharmacovigilance/multivigilance process.
Integrating Sensor-Generated Data to Drive Clinical Decision-Making
September 20th 2022Tue, Sep 20, 2022 10:00 AM EDT The seamless integration of data collected on patient behaviors and experiences is critical to improving the efficiency and effectiveness of clinical decision-making at scale in clinical research and development. Yet, the potential of sensor data to transform health outcomes is being held back by a fragmented landscape of device solutions, regulatory complexity, and obstacles in interoperability.
Understanding the role of the investigator in decentralized trials
March 29th 2022Tuesday, March 29, 2022 at 1 pm EST, 12 pm CST, 10 am PST The popularity of decentralized clinical trials (DCTs) is making oversight of investigators more critical. As trial operations spread and become more remote, the role of the investigator as a center of gravity becomes increasingly vital. Approaching regulatory agencies to understand if there are regulatory issues with a proposed DCT solution will likely lead to more non-standardized regulations, which in turn creates additional regulatory uncertainty. What can be done?
Smarter Signal Management: AI, big data, and predictive analytics
February 15th 2022What if you could predict potential safety issues before clinical development begins? Innovative new signal detection and management approaches have been developed to help clinical trial sponsors, manufacturers, and CROs combat safety-related challenges and provide insight to be used to predict potential safety issues even before clinical development begins. Applying those learnings to their choice of initial research candidates can ultimately mean safer medicines for patients.
The Next Domino: Automation, AI, and touchless safety case processing
February 15th 2022With the increasing volumes of adverse event reports and stagnant budgets, the time is now for a revolutionary change in drug and device safety case management. A robust management process is necessary for identifying and evaluating adverse events (AE) and reporting them properly to regulators.
