Insights On Trial Design

1. Modern Oncology Research Landscape: Staying Ahead Of The Game 6/11/2020

   Companies that can position themselves strategically during preclinical explorations and throughout the development process can bolster their chances of achieving approval and market success. To do so, they must understand key elements of the “new” oncology research landscape.

2. Bayesian Statistics In Early Phase Clinical Trials 1/7/2021

   Bayesian clinical trials are gaining prominence across the clinical development journey. Learn how to employ Bayesian statistics in early phase trials with Professor Yuan Ji of the University of Chicago, including two new innovative clinical trial designs invented by Professor Ji that are quickly gaining popularity.

3. Simple SOP Updates Every Research Site Needs To Succeed At Remote Monitoring 9/8/2020

   Today’s crisis climate is creating a dichotomy in clinical research. As a result, sites are closing, medical facilities are enforcing access restrictions, and there are constant delays or stoppage of non-essential studies. On the other hand, this health crisis is highlighting the critical need for clinical research due to ongoing COVID-19 trials. As a result, clinical researchers are asking questions and seeking workarounds to continue operations in response to site-specific adjustments. One central issue has surfaced — how do we continue to maintain compliance when working from home?

4. Basket Clinical Trial Designs: The Key To Testing Innovative Therapies Is Innovation In Study Design And Conduct 3/4/2020

   As the science behind therapeutic interventions has deepened and grown, the clinical trial designs through which those interventions can be best tested have evolved as well. To study therapies directed against specific abnormalities, in cancer for example, it may make sense to include anyone with the target abnormality in the trial population, regardless of the location of their cancer.

5. Supply Chain Models For Global Trials: Singapore As The APAC Gateway To The World 7/21/2020

   With an increasing number of clinical studies being conducted in the Asia-Pacific (APAC) region, there is a growing need for streamlining import and export strategies and clinical supply support. Multiple factors, including positive changes in clinical research regulations, reduced costs to run trials, and large urban-centered populations are attracting sponsors to the region. Watch this webinar to get expert insight on using Singapore as a clinical supply hub.

6. Why Remote Site Monitoring Is On The Rise And How To Deploy It At Your Organization 1/12/2021

   The COVID-19 pandemic has accelerated the ongoing shift to remote clinical trial monitoring. In this article, we explore challenges of traditional monitoring, benefits of remote clinical trial monitoring, how to deploy remote clinical trial monitoring, sponsor-deployed remote monitoring technology, and site-procured remote monitoring technology.

7. Investigational New Drug Applications: Five Solutions To Common Problems 7/30/2019

   There are many pitfalls that come with preparing an Investigational New Drug (IND) application for FDA submission, but with the right plan – and the right partner – there are also plenty of ways to avoid them. Here are five actionable steps can help ensure your next IND is a successful one:

8. Key Biosafety Considerations For Coronavirus Research 3/17/2020

   New and emerging infectious diseases like coronavirus are a fact of life, but the reaction of the research community can impact how far they spread. Learn how biosafety measures help advance vaccine development in our recent blog article.

9. Advanced Design Framework: Part 2 – The Need For A Quantitative Evaluation Approach For Deciding 11/2/2020

   Has your organization ever completed the execution of a long, expensive Phase 3 clinical trial only to learn that the organization is unable to commercialize the therapy? This blog shares how to effectively incorporate varied perspectives to efficiently design innovative clinical trials.

10. Study Activation: A Complex Process That Doesn’t Have To Be Painful 4/22/2020

    Long activation timelines are a familiar concept in the clinical trial landscape. How can your site improve its study activation timelines?