The agency’s effort to fight the deadly disease now includes taps the pharma company’s testing tools to help speed up diagnosis and grow treatment access.
A leader from the trial management specialist says sites and sponsors prepare for International Council for Harmonization guideline changes on the horizon.
The University of Kansas Cancer Center has joined with trial tech provider Complion to develop a shared investigator platform for use in a range of studies.
Formerly Parexel Informatics, the renamed clinical research technology company has broken off and will operate as an independent company going forward.
The pharmaceutical and biotech product development consultancy Boyds acquires Blue Duck Consulting to boost its clinical and medical affairs services offering.
Veristat launches clinical trial, biostatistics, and programming operations in Taipei, Taiwan in response to increasing client demand for regulatory submission support for both local and North American-based sponsors.
MMS Holdings launched its cloud-based quality control application, Automatiqc, to meet quality control needs rapidly through its customizable software, according to the CRO.
Smaller company’s last year led in new drug approvals, nearly half of which were for the treatment of rare diseases, as the industry shifts away from the need to scale infrastructure, says Tufts director.
Senator Flake will discuss regulatory guidance impacting innovation and his perspective on the state of the industry during his keynote address at CPhI North America.
Camber and Macleods voluntarily recall losartan tablets lots, after trace amounts of a possible carcinogen found in an API ingredient manufactured at the same third-party facility.
US FDA initiates a pilot project testing innovations in an aim to inform the development of the tracking and verification systems going into effect with the DCSA in 2023.
By Barbara Lopez Kunz, global chief executive, DIA
The practice of incorporating the voice of the patient into clinical development has gained significant traction over the past decade, and rightfully so.
