E6 (R3) on Horizon
Recent webcast addresses what organizations can do to prepare for the next revision of ICH E6.
Pandemic Shines Spotlight on Clinical Trial Conduct and Regulation in 2020
Looking back on regulatory challenges created by COVID in 2020.
Industry Forced to Rethink Patient Participation in Trials
EVP and General Manager of Hū, April Lewis, discusses why the industry has seen a decline in trial participation and what Hū is doing to combat it.
Top 5 Global Clinical Trial Disclosure Changes in 2020 Amidst Pandemic
Spotlight on clinical trials created by COVID-19 pandemic has forced regulatory officials around the world to expand disclosure requirements on results.
Managing Risks in Clinical Trials During a Pandemic with ICH E6 (R2)
COVID-19 pandemic forces compliancy within organizations following FDA’s 2018 revision of Good Clinical Practice in federal registry.
Applied Clinical Trials, December 2020 Issue (PDF)
Click the title above for a link to open the Applied Clinical Trials December 2020 issue in an interactive PDF format.
Importance of Diversity in Parkinson’s Research
Eliminating barriers to engage underrepresented populations.
Regulatory Data: How Technology Can Help ClinOps Survive
Clinical operations professionals, burdened by lack of data standardization, turn to technology in hopes of streamlining regulatory processes for the future.
Decentralized Trials, Pros and Cons
Regulatory concerns remain despite industry's quick adaptation of decentralized trials.
Public Trust and the ‘Last Mile’ for COVID-19 Vaccines
Battle for trust ensues as vaccines are set for approval.
The Ever-Changing Face of NICE Guidance on Drug Innovation
While the UK's departure from the EU is imminent, NICE will continue to influence thinking around the continent.
Investigative Site Placement Practices to Support Operation Warp Speed
Comparing late-stage COVID-19 vaccine trials to historical practices.
Radiomics: What It is and What It Can Do for Clinical Trials
Radiomics can help life sciences companies realize the full value of their imaging pipelines.
Gender Bias in the Clinical Evaluation of Drugs
Past decades have shown gender-based differences in clinical trial results are often overlooked when considering safety and effectiveness.
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