1 min read

ACRP | DCTs: Key Considerations for Small-to-Midsized Biotechnology and Biopharmaceutical Companies

Decentralized clinical trials (DCTs) are no fad; they are entrenched in the future of clinical development.

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1 min read

Applied Clinical Trials: Unraveling DCT Misconceptions

DCTs can be a great tool for small-to-midsize pharma and biotech companies despite misconceptions of them being advantageous for only Big Pharma.

6 min read

New Guidance on Diversity in Clinical Trials Planning. Monitoring. Compliance

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

4 min read

How to Comply with New MHRA Guidance

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

1 min read

The News No Sponsor Ever Wants To Receive

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

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PharmaLive: Decentralized Clinical Trials are Here to Stay

The technology is designed to enable connection to any source data system, enabling connectivity in identifying, monitoring, and managing trial risks.

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Key Considerations When Implementing a Decentralized Trial

The popularity of decentralized clinical trials (DCTs) is surging—especially among patients. Harnessing technology of all kinds, these trials provide an attractive alternative to the old-style site-anchored system on which traditional clinical trials have rested. They also have the potential to provide better, more timely data, since that data is largely collected under real-life situations and

1 min read

A Practical Guide to Using Machine Learning for RBQM in a New Clinical Trial Landscape

Artificial intelligence technology, including machine learning (ML), is an increasingly hot topic in clinical research, but there are still important questions to be answered when putting these systems into action. This practical webinar will help set your organization up for success by offering a fresh perspective on the key goals of risk-based quality management (RBQM)

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Overcoming Barriers to Embracing Data

As an industry, we are drowning in data. But are we using it effectively? We know that the best way to make truly informed decisions is to ground them in facts — and that only by seeing all the data as a whole are we able to have the necessary context. Yet often, we don’t