News

This latest guidance provides a 15-year update on the recommendations, including the use of CGM devices.

Facility upgrade will support clinical supply demand for CGT development.

Agency hopes to update and improve its advisory committee composition and operations—to help FDA scientists “get the best advice possible.”

Harsha K. Rajasimha, PhD, founder and executive chairman, IndoUSrare, provides the OCT audience insights into better achieving DEIA clinical trials.

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 partners with THREAD to launch Allucent Patient Direct Trials, a DCT offering focused on small and mid-sized biotech companies.

New solution delivers simplified questionnaire licensing and localizations, streamlined device logistics, and improved data integrity.

UCB will adopt Veeva ePRO and Veeva eConsent.

New capability added to VIDA Intelligence Platform will streamline quality-controlled data curation.

Senior leaders gather to share insights on the increased investment in real-world data to boost the quality and efficiency of drug development—as the industry begins to more widely embrace evidence of proven outcomes in aiding approaches in clinical trial design, patient engagement, regulatory decision-making, and other areas.

Latest enhancements will optimize Omnichannel capabilities for ROI reporting.

Examining the two areas of weakness cited in FDA draft guidance.

The latest people and business news from the past month, all in one place.

Stakeholders must alter their mindsets when it comes to early-phase design and interpreting regulatory guidance for CGT trials.

EMA opens formal consultation on the pros and cons of basing pivotal evidence for new drug submissions on SAT data.

Cristina Varner, LUTCF, ARM, SVP/national life science and digital health & telemedicine practice leader at insurance brokerage Newfront explains the nuances of insuring clinical trials in today's growing digital health climate and the newer risks in areas such as cybersecurity that developers are facing.

Worldwide will serve as Every Cure’s clinical trial and drug development partner.

Increased data output from the use of devices can accelerate trials for this therapeutic area in need of new therapies.

Parexel identified five roadblocks to participation and eight solutions for designing more equitable clinical trials for transgender and nonbinary patients.

Tool targets advanced drug monitoring and safety—and enables access to real-world data.

Clinvest Research specializes in chronic diseases and conditions including migraine, arthritis, and diabetes.

New technology aims to streamline cancer treatment process.

Acquisition of two previously merged companies bolsters ACRS’s patient-centric solutions for clinical development.

French and Spanish CROs combine on expertise to address cross-country clinical trials.

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.

Recommendations apply to where some or all the trial-related activities occur at locations other than traditional clinical trial sites.

Clariness tasked with gathering data on digital device usage behaviors, app and notification preferences, and previous trial experiences.

Flatiron Health’s scalable EHR-to-EDC technology to enable efficient site data transfer for faster access to cleaner data with less burden.