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ICH E6-R2 has taken another leap forward as quality-focused personnel have shifted focus to vendor oversight plans, essential document management, and evaluating quality tolerance limits in more depth.






The latest happenings in the industry from the past month, all in one place.


Now officially a worldwide pandemic, the biomedical research community is rushing to develop treatments and preventives to halt the spread and severity of the COVID-19 virus.

Jing Zhao, Chief Business Officer of Refuge Biotechnologies, discusses how dead cas9 can be leveraged to completely control gene expression without making permanent edits as seen with CRISPR technology.

The Clinical Study Data Request consortium is actively pursuing platform interoperability to allow data to be merged and analyzed as an important step for advancing human healthcare.





The need for biopharma companies to equip data managers with the training and resources necessary to capitalize on new digital health tools.

Breaking down the evolving role of today’s clinical data manager-and its importance as a key cog in the clinical research ecosystem of tomorrow.

Tzvia Bader, CEO of TrialJectory, discusses how the company’s AI-powered technology platform is democratizing cancer care and expanding access to advanced new treatments.

With the Coronavirus causing significant disruptions in the clinical trials industry, Sponsors should expect data quality issues due to missed visits and a reduction in enrollment rates.

Though on its way out of the European Union, the UK is trying to align its trial approval practice with the EU’s new clinical trial regulation.

Ravi Jandhyala, Consultant Pharmaceutical Physician at Medialis and an expert in rare disease patient registries, discusses how to overcome clinical trial registry challenges.

With radio, billboard, TV, and digital advertisements being left in the dust, additional engagement from influencer communities are more likely to be reach patients.




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