Blog
Choosing Between Provisioned, BYOD, and Hybrid Models for ePRO: Which Is Right for Your Clinical Trial?
As more and more trials opt to include electronic patient reported outcomes (ePRO), sponsors must consider whether they will provision devices or use a bring-your-own-device (BYOD) model. In some cases, they may choose a hybrid option that allows some participants to...
WCG Expands Clinical Trial Technology and Services with Acquisition of VeraSci
WCG today announced the acquisition of VeraSci, a global provider of specialty scientific expertise and eClinical software to support the design and execution of clinical trials focused on central nervous system (CNS) disorders. The addition of VeraSci, based in...
How Can Clinical Trial Data Be Returned to Study Participants in a Compliant and Ethical Manner?: New IMI-2 Funded Project Seeks Answers
The Framework for Clinical Trial Participants’ Data Reutilization for a Fully Transparent and Ethical Ecosystem (FACILITATE) is a new Innovative Medicines Initiative (IMI) funded project to find an ethical and GDPR compliant framework for returning clinical trial data...
Can Your ePRO for Pediatric Clinical Trials Support Multiple Informants?
Like clinical trials in adult populations, pediatric clinical trials increasingly incorporate electronic patient-reported outcome (ePRO) systems to gather data directly from patients. One challenge unique to pediatric trials is that many trials also seek to gather...
Digital Phenotyping Presents Opportunity to Better Understand Vulnerability to Emotional and Behavioral Issues in Adolescent Oncology Patients
Adolescent oncology patients can be vulnerable to a great deal of emotional and behavioral challenges. But which young people are most susceptible is very difficult to predict. An article recently published in Frontiers in Oncology discusses how digital phenotyping...
New Approaches for the Value Assessment of Advanced Medical Products
The journal Clinical Drug Investigation recently published the article “New Models for the Evaluation of Specialized Medicinal Products: Beyond Conventional Health Technology Assessment and Pricing” which was co-authored by Dr. Luca Pani, VP Regulatory Strategy and...
VeraSci Partners with Boehringer Ingelheim on Innovative Phase III Program for Breakthrough Therapy in Cognitive Impairment Associated with Schizophrenia
Today, Boehringer Ingelheim announced that they are partnering with VeraSci on an innovative phase III program in cognitive impairment associated with schizophrenia (CIAS) for the investigational treatment BI 425809. The FDA has granted Breakthrough Therapy...
Recent Innovations and their Regulatory Implications for Multiple Sclerosis Trials Addressed in a Special Issue of the Journal of Clinical Neurophysiology by VeraSci Experts
This week, the Journal of Clinical Neurophysiology published a special issue about recent innovations and their regulatory implications for clinical trials in multiple sclerosis. Dr. Mark Skeen, Senior Medical Scientist at VeraSci and Professor of Neurology at Duke...
The Parkinson’s Foundation and the Parkinson’s Study Group Provide Recommendations on Overcoming Challenges in Telehealth for Clinical Research Studies
Members of the Parkinson’s Foundation and the Parkinson’s Study Group (PSG), including VeraSci Senior Clinical Director of Movement Disorders Dr. Travis Turner, recently published a consensus statement titled “Expediting telehealth use in clinical research studies: recommendations for overcoming barriers in North America” in Nature Partner Journal (NPJ) Parkinson’s Disease. The paper outlines supporting evidence as well as barriers and solutions to implementation.
New Scale for Measuring Non-Motor Fluctuations in Parkinson’s Disease
The Non-Motor Fluctuations Assessment Questionnaire (NoMoFA) is a patient-reported outcome measure that seeks to characterize the non-motor symptoms that may fluctuate in parallel with motor symptoms.