Blog
Innovation Lab Releases Preliminary Findings in Wearables Study
This blog series shares what’s happening day-to-day in our Innovation Lab. VeraSci created the Innovation Lab to pair scientific knowledge with cutting-edge technology to improve the tools and measurements available for clinical trials. We originally presented these...
Regulatory Challenges in Pediatric Drug Development: The European Perspective
Dr. Luca Pani is the former Director General of the Italian Medicines Agency and a former member of the Board of Directors of the Committee...
Using eCOA to Improve Data Quality in Parkinson’s Disease Clinical Trials
One of the most frequently used assessments in clinical trials of Parkinson’s Disease is the Movement Disorders Society version of the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS). Producing high-quality data is crucial for demonstrating efficacy for new...
New Consensus Research Criteria Present Opportunities for Advancement of Research in Dementia with Lewy Bodies (DLB)
In a recent article published in Neurology, the Dementia with Lewy Bodies (DLB) Consortium published new consensus research criteria for prodromal DLB. These new criteria have the potential to significantly impact clinical trials and the development of drugs for DLB.
Case Study: Maintaining Trial Continuity During COVID-19 Using Remote Assessments
As the COVID-19 pandemic halted many in-person clinical trial visits, sponsors were faced with difficult decisions about whether to delay, cancel, or modify their on-going clinical trials. One option for some trials was to replace in-person visits with remote or...
Appreciating the Complexity of Remote Assessments
As the COVID-19 pandemic made in-person visits difficult or impossible, sponsors and CROs turned to remote visits and remote assessments to keep trials running. This is an approach to which several regulators have signaled interest and VeraSci has endorsed. After...
Improving Data Quality for a Critical Multiple Sclerosis Endpoint
The Expanded Disability Status Scale (EDSS) is one of the most widely used endpoints in multiple sclerosis (MS) research and in clinical trials of investigational treatments for MS. The EDSS is an elaborate scoring system applied to a neurological examination that...
Update: ISCTM Brings Together FDA, EMA, & Industry for Working Group on Adapting Trials for Remote Assessment
We recently wrote about the first two special meetings of the Innovative Technologies Working Group of the International Society for CNS Clinical Trials and Methodology (ISCTM) to discuss challenges related to implementing remote assessments in CNS clinical trials in the context of COVID-19 precautions. These calls provided an open forum for discussion between FDA, industry, academia, and clinical trial sites. There has since been a third call, which also included participants from EMA sharing their views.
From the Innovation Lab: Wearable Insoles for Real-Time Capture of Gait Measures
Preliminary Feasibility and Validity Data in Older Adults with and without Subjective Cognitive DeclineThis blog series shares what’s happening day-to-day in our Innovation Lab. The VeraSci Innovation Lab was created to pair scientific knowledge with cutting-edge...
The Placebo Control Reminder Script—Now Available on Pathway
Placebo response is a potentially devastating component of CNS trials, particularly those with subjective patient-reported outcomes and high levels of interaction with clinical staff. In pain, depression, and other psychiatric studies using subjective primary...