
Examining the two areas of weakness cited in FDA draft guidance.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

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.

New patient-facing digital platform provides access to trial-related information such as financial views, submission of receipts for reimbursement, and more.

Webinar Date/Time: Thursday, May 25th, 2023 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

Partnership Network gives sponsors and CROs the opportunity to share data and solutions.

January 2023 guidance from FDA on dosages in oncology provides further context on expectations with Project Optimus.

Survey shows comfort with e-signatures is on the rise, yet healthcare consent still lags.

Acquired site has specialized in neurodegenerative diseases for over 25 years.

Company opens research site in Littleton, CO.

Partnership will provide patients with Individual Access Services and allow them to securely access their personal health information.

Partnership optimizes trial planning and efficiency.

Company provided pro bono support for Great Ormond Street Hospital-sponsored study into new treatments for children with SCID.

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

Walgreens and Prothena partner to increase access and enrollment in Alzheimer’s disease clinical trial

The Contract Network aims to solve the usually slow clinical trial agreements process with new contracting platform.