With safety data being just as important as efficacy findings, the most critical factor in clinical trial success is risk avoidance—and central monitoring is a core component of risk-based monitoring. Traditional monitoring, also known as source data verification, happens long after the event and only examines individual data points—providing no insight into overall study data…
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Modern clinical trials generate reams of data from multiple sources, creating enormous information management challenges for sponsors. Today, the growing popularity of decentralized clinical trials (DCTs) only exacerbates the problem. It is not enough to cobble together multiple management systems; these new approaches to trials require new clinical trial management systems (CTMS). A modern CTMS…
Decentralized clinical trials (DCTs) are no fad; they are entrenched in the future of clinical development.
DCTs can be a great tool for small-to-midsize pharma and biotech companies despite misconceptions of them being advantageous for only Big Pharma.
Clinical trials have long suffered from a lack of racial and ethnic diversity. There are many reasons—geographic, socio-economic, historic, and educational. Yet the safety and efficacy data which drives them is only helpful if it accurately reflects outcomes in the entire population for whom the product will be prescribed. The recent spotlight on matters of…
Clinical studies are expensive to mount—so given the high stakes, sponsors and contract research organizations (CROs) are under pressure to reach conclusions swiftly but without ever jeopardizing patient safety. One solution: Risk-based strategies that enable sponsors to zero in on issues in real time. Now, new governance underscores continuing regulatory support for—and perhaps even insistence…
When pharmaceutical companies hire a contract research organization (CRO) to manage their clinical trials, they may assume that the trial management includes detailed oversight of data collection and analysis. It does most of the time, but ultimately, the responsibility for data governance remains with the sponsor. This lesson was brought home to many sponsors on…
The technology is designed to enable connection to any source data system, enabling connectivity in identifying, monitoring, and managing trial risks.