News

The TMF Reference Model has released a survey for industry professionals designed to provide insight for both paper and electronic trial document management.

INC Research announced the expansion of its Functional Service Provider (FSP) service offering

iCardiac Technologies has announced the launch of its new eCOA platform, QPoint.

OmniComm Systems and Bio-Optromics have reached an agreement with a CRO seeking to develop cancer treatments, for the use of their EDC and CTMS solutions.

Clinerion and ASUS Life have signed an agreement to deliver services for running clinical trials, clinical patient recruitment, market access and real-world evidence in Taiwan.

ICON plc announced that the US FDA has awarded the company with a project validating three Patient Reported Outcomes instruments that will measure clinical endpoints in antibacterial drug trials.

The Clinical Trials Transformation Initiative (CTTI) has released recommendations to improve the quality and efficiency of clinical research studies used to develop antibacterial drugs for children.

IntrinsiQ Specialty Solutions and ION Solutions, both of AmerisourceBergen, have announced the launch of AdvanceIQ Network.

PAREXEL has launched a mobile app for its ClinPhone randomization and trial supply management service.

ProTrials Research has announced the expansion of their clinical suite to include data management services.

As pharma continues to struggle with designing studies that result in creating breakthrough medical therapies, biopharma sponsors focusing on CNS studies face similar challenges and risks.

The Association of Clinical Research Professionals has released a harmonized Core Competency Framework for Clinical Research Associates that defines core competencies.

ERT has launched its refreshed eCOA technology environment, with enhanced features on the back-end to make eCOA easier for patients to use, and more cost effective and faster for sponsors to implement.

The latest version of the Prescription Drug User Fee Act has sponsors and FDA officials pressing for Congressional action regarding the program’s provisions accelerating the drug development and application review processes.

Veeva Systems announced the future release of Veeva Vault Submissions Publishing, a cloud application that incorporates publishing capabilities within Veeva Vault RIM to speed regulatory submission delivery.

Montrium announced the release of the Regulatory Navigator, an interactive intelligence dashboard integrated into the company’s RegDocs Connect, a Regulatory EDMS solution.