Orchestrating Different Levels of a Successful Clinical Study Start-Up
Similar to a world-class symphony, a curated site start-up model can accentuate its individual components and lead to swift starts for clinical trials.
COVID-19 Puts Spotlight on Study Start-up
Sujay Jadhav, global vice president, study start-up, Oracle Health Sciences, spoke with ACT on how study start-up has been impacted by the pandemic and what its future holds beyond COVID.
Fast Tracking Study Start-Up from Site Selection to First-Patient Enrollment
With a major wave of post-COVID trial starts on the horizon, the industry’s need to accelerate clinical research through study start-up is intensifying.
COVID-Related Changes Have Implications for Public Acceptance of Innovation
COVID-19 pandemic shifts traditional process for medicine development in Europe.
Early Vaccine Authorization Raises Ethical and Logistical Challenges for Trial Sponsors
FDA’s Vaccines and Related Biological Products Advisory Committee addresses issues related to testing and approval of potential COVID vaccines.
FDA Reassurances Always Go a Long Way
The FDA hints that their increased speed in issuing guidances during the pandemic could become the new norm.
Applied Clinical Trials, November 2020 Issue (PDF)
Click the title above for a link to open the Applied Clinical Trials November 2020 issue in an interactive PDF format.
News Notes (November)
A compilation of recent notable news developments that pertain to the clinical trials industry.
Employing the Power of Bayesian Methods to Expedite Learning
Bayesian methods bring flexibility and speed to clinical trial design and analysis, and with increased access to the necessary computational power, are transforming today’s clinical research.
Gold Standards Remaining Gold Standards for Germany's HTA
Declarations made by Beate Wieseler don't align with those of many regulators and HTA bodies in Europe and will prove tough to transform.
