Decentralized clinical trials pose unique challenges because the critical elements of the trial, from administering treatment to recording and verifying data, no longer take place under the watchful eye of the investigator.
Considering the importance of how not to lose track of how real people fit into where the clinical research enterprise is headed with its current deep dive into big data, artificial intelligence, and other tech-driven trends.
While many sites have not yet transitioned away from the traditional paper-based source model for data, electronic source may represent an efficient systematic alternative to this traditional method.
Transformation in the life sciences sector are being driven by the adoption of artificial intelligence, machine learning, and natural language processing, and by the exploitation of “big data” sources in new and powerful ways.
Regulatory bodies have recently published recommendations that aim to facilitate the conduct of decentralized trails while safeguarding participants and the data collected.