Medicare Still Won’t Pay for Alzheimer’s Drugs Without Confirmatory Data
Indicates that reimbursement for new slate of Alzheimer’s treatments will occur only with the completion of studies to support full approval.
Study Captures Ethnic Disparities in Pain Reporting
Using uMotif eCOA/ePRO data capture app, significant ethnic disparities in pain recognition and management are revealed.
Ongoing Oncology Studies Update - June 5, 2023
Latest number of oncology clinical trials from ClinicalTrials.gov.
Quanticate Announces Strategic Partnership with KPS Life
Under new agreement, companies can receive biometric data services from Quanticate coupled with global resourcing solutions from KPS Life.
QualityMetric Provides Translations for Global Study in Youth Living with HIV
Caregiver-completed pediatric survey was developed in 12 different languages, including new translated versions to ensure comparable measures.
WCG Unveils Results from 2023 Global Site Relationship Benchmark Survey Report
Benchmark survey provides timely insights into clinical trial sites' relationships with sponsors and CROs post-pandemic.
Mural Health and Clinflash Announce Strategic Partnership
Partnership will enable international sponsors to deliver patient payments globally, including China.
FDA On Track to Update Diabetes Efficacy Endpoints Guidance
This latest guidance provides a 15-year update on the recommendations, including the use of CGM devices.
Catalent Adds Cryogenic Capabilities in Shiga, Japan
Facility upgrade will support clinical supply demand for CGT development.
FDA Eyes Advisory Committee Reform to Enhance Credibility
Agency hopes to update and improve its advisory committee composition and operations—to help FDA scientists “get the best advice possible.”
OCT East 2023: Achieving Global DEIA in Clinical Trials
Harsha K. Rajasimha, PhD, founder and executive chairman, IndoUSrare, provides the OCT audience insights into better achieving DEIA clinical trials.
CVS's Closure of Its Clinical Trial Unit and What it Means for The Future
In this Q&A, Craig Lipset offers additional insights following the announcement that CVS will be closing its clinical trial services business by the end of the year.
Allucent Launches Decentralized Clinical Trial Solution
Allucent partners with THREAD to launch Allucent Patient Direct Trials, a DCT offering focused on small and mid-sized biotech companies.
Suvoda Announces General Availability of New eCOA Solution
New solution delivers simplified questionnaire licensing and localizations, streamlined device logistics, and improved data integrity.
UCB and Veeva Announce Collaboration
UCB will adopt Veeva ePRO and Veeva eConsent.
VIDA Launches Cloud-Based Case Viewer
New capability added to VIDA Intelligence Platform will streamline quality-controlled data curation.
Trialbee Honey™ Adds New Features
Latest enhancements will optimize Omnichannel capabilities for ROI reporting.
People and Business News – 5/23
The latest people and business news from the past month, all in one place.
Single-Arm Trials Start to Strong-Arm Their Way into European Regulation
EMA opens formal consultation on the pros and cons of basing pivotal evidence for new drug submissions on SAT data.
Worldwide Clinical Trials Partners With Every Cure
Worldwide will serve as Every Cure’s clinical trial and drug development partner.
Parexel Publishes Findings on Making Clinical Research More Accessible for Gender-Diverse Populations
Parexel identified five roadblocks to participation and eight solutions for designing more equitable clinical trials for transgender and nonbinary patients.
Seqster Launches MyAlzheimer's Patient Registry
Tool targets advanced drug monitoring and safety—and enables access to real-world data.
Headlands Research Acquires Clinvest Research
Clinvest Research specializes in chronic diseases and conditions including migraine, arthritis, and diabetes.
Leal Health Launches Predictive Patient Journey Solution
New technology aims to streamline cancer treatment process.
American Clinical Research Services Acquires Clinical Site Services and Patient Advertising Guru
Acquisition of two previously merged companies bolsters ACRS’s patient-centric solutions for clinical development.
Investment to Create Pan-European CRO
French and Spanish CROs combine on expertise to address cross-country clinical trials.
Phesi Publishes Digital Patient Profile Catalog
Profiles are based on data from more than 60 million patients, with aim to enable adoption of digital twins and improve patient centricity in drug development.
FDA Issues New Draft Guidance on DCTs
Recommendations apply to where some or all the trial-related activities occur at locations other than traditional clinical trial sites.
Clariness Announces Role in Supporting YPrime's Patient and Site eCOA Initiatives
Clariness tasked with gathering data on digital device usage behaviors, app and notification preferences, and previous trial experiences.
Sanofi to Utilize Flatiron Clinical Pipe™ in Oncology Clinical Trials
Flatiron Health’s scalable EHR-to-EDC technology to enable efficient site data transfer for faster access to cleaner data with less burden.