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International regulation: the importance of quality assurance in drug development

European Pharmaceutical Review

As drug development professionals know, global health crises like the COVID-19 pandemic provide the public with valuable insights into how clinical research and regulatory processes work.

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COVID heralds a faster future for drug development (if stakeholders can collaborate)

pharmaphorum

Drug development alone is not really working to solve [chronic illness],” he added, noting that BIOS aims to use AI to read these neural signals, find out how they work and eventually control them to produce a therapeutic effect. In the UK we have world leading genetic sequencing capabilities.

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How using AI in clinical trials accelerates drug development

Pharmaceutical Technology

Drug development is already a difficult endeavor, with the vast majority of R&D efforts failing to produce a market-worthy product. Even reaching the clinical trial phase offers no guarantees, as only 12% of such drugs receive U.S. While this process is essential, it’s also slow, expensive and unpredictable.

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Connecting with Patients at Home

Pharmacy Is Right For Me

There are so many different types of careers within the field of pharmacy—from research and drug development to pharmacy informatics! Another unique aspect of this model is that all interprofessional team members can access and document within a universal electronic medical record (EPIC).

Hospitals 130
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How to Run DMC? It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials

FDA Law Blog: Biosimilars

Other Oversight Groups Both documents described the role of other oversight groups, in addition to DMCs, that may be involved in a clinical trial in similar, sometimes overlapping, roles such as IRBs, trial steering committees, and site monitors. Increased Connections Between a DMC and FDA?

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FDA suggests ways to curb constraints with rare disease gene therapy trials

Pharmaceutical Technology

In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases. This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development.

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How blockchain can revolutionise medical records and save lives

pharmaphorum

Additionally, issues such as poor quality documentation due to template-based reporting, and incompatibilities between different systems have further caused headaches and increased inefficiencies. Many practitioners have expressed the feeling that EHRs cause far too much of their time ultimately being spent on data entry.