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Digital tools driving innovative clinical trials

pharmaphorum

The COVID-19 pandemic has catalysed significant changes in the way pharma develops drugs, particularly in the clinical trial space. Hybrid or decentralised clinical trials (DCTs) have gained traction as technology, infrastructure and knowledge have evolved to support their use. Source: Izmailova et al, 2017.

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Can technology help diversify clinical trials?

pharmaphorum

This is the second in a two-part series examining how pharma can embrace the DEI agenda to create more effective medicines through more representative clinical trials. The same principles are increasingly being applied to clinical trials to improve diversity, mitigate bias, and reinforce inclusion in clinical trials.

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Sweeping changes in leaked EU pharma law draft reignite profit vs access conflict

Pharmaceutical Technology

The EU is planning a sweeping revision of its pharma legislation in March, the largest change in 20 years. The overhaul will address drug marketing exclusivity length, pricing, patient access, innovation incentives, antimicrobial resistance, clinical trials, supply chain security and shortages, and environmental impact.

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EMA pilot will see if clinical trial data should be digested ‘raw’

pharmaphorum

A pilot study has been launched by the EMA to see whether it is helpful for regulators to look at the ‘raw data’ from clinical trials submitted in support of new marketing application along with the usual structured analyses from sponsors.

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Biogen continues to sink

World of DTC Marketing

What has/is happening at Biogen is a train wreck, and the only way to correct this disaster is to tear it down and rebuild the company from the top down. ” To me, an enormous warning flag went up when the VP of Market Access was on a call with the commercial organization (sales). Click to Tweet.

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Increasing patient engagement with UK clinical trials

pharmaphorum

Pharma companies face many challenges when involving patients in the design of clinical trials – but doing so can have huge benefits further down the line, improving the sustainability and quality of research. Involving patients in discussions.

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Clinical Data Management Experts Share Insights on Modern Digital Clinical Trials

XTalks

In this interview, Xtalks spoke with experts from eClinical Solutions , Katrina Rice, Chief Delivery Officer, Data Services; and Diane Lacroix, Vice President, Clinical Data Management, about clinical data management for modern day digital clinical trials. Data security: The clinical trial data is backed-up and secure.