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Transforming clinical data management systems for biotechnology trials

pharmaphorum

Learn how biotechnology trials are transforming clinical data management systems, leveraging machine learning and advanced protocols to enhance efficiency and accuracy in data collection and analysis.

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Fixing clinical trial data management

pharmaphorum

It’s 2024 and in most clinical trials, data is still being moved from the EHR to the EDC manually – with employees reading data from one screen and typing it onto another. How did we get here? And how do we get past it?

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Pfizer’s initiative to return clinical trial data to patients

pharmaphorum

Pfizer’s initiative to return clinical trial data to patients Mike.Hammerton Fri, 08/12/2023 - 11:00 Bookmark this

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FDA Releases Final Guidance on Use of Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

The FDA Law Blog

Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. The guidance addresses the use of DHTs in clinical investigations of drugs, biologics, and medical devices.

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5 Reasons to Upgrade Your Pharmacy Management Software

Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software.

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STAT+: U.K. becomes the first country to release detailed data on sponsors that fail to register clinical trials

STAT

The United Kingdom has released comprehensive data showing which institutions have failed to register their clinical trials, a move that was hailed by transparency advocates who say this marks the first time that a country has taken such a step. The findings were notable. In 2022, 92% of the trials had been registered. database.

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When Should a 510(k) Include Clinical Data?

The FDA Law Blog

Lenz, Principal Medical Device Regulation Expert — Although it seems not widely known outside of the medical device industry, FDA can require sponsors to include clinical data as part of a 510(k) submission. The Draft Guidance provides specific examples illustrating the application of each scenario.

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.