Newsletter | September 14, 2021

09.14.21 -- Regulatory And Innovation Updates -- Drive Operational Efficiencies In Study Initiation

Parallelization: Imperative To The Compression Of Clinical Trial Cycle Times

With unrelenting pressures to rein in budgets and cycle times, the application of project management techniques to study startup holds the key to optimizing operational efficiencies and compressing timelines. Use visualizations and standardized metrics to aid in the identification of white space and machine learning algorithms to guide timing of parallelization of processes to minimize risks associated with intervention.

Redefining Clinical Strategy With Scenario Planning

Key assumptions are made at the outset of setting up a clinical trial surrounding country and site selection. What if those assumptions shift? Do you know with a certain level of confidence how changes in those assumptions will impact the execution of the study? This is why scenario planning is so valuable and critical to helping to manage the variability in clinical trial setup decisions.

How Will ICH E8 (R1) And E6 (R3) Make Clinical Trials Oversight More Efficient?

ICH-based regulations have traditionally led to more overhead in the form of processes, headcounts, and systems. These regulations concerning oversight cascade to all stakeholders, further increasing complexity and associated costs. The forthcoming ICH E8 (R1) and ICH E6 (R3) guidelines renew the focus on efficiencies in conducting clinical trials and provide tools to do so — significantly impacting oversight.

EU Set To Attract More Clinical Trials With Streamlined Submission Process
The way clinical trials are conducts in the EU will undergo a major change when EU regulation number 536/2014 comes into effect in January 2022. This new regulation is binding across all member states and provides sponsors and CROs alike with an opportunity to rethink how technology plays an important part in bringing efficiencies to clinical trials.
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