How to connect the common goals of varying clinical trial stakeholders
All clinical research stakeholders are looking to deliver better patient outcomes faster, though silos across the industry are creating a disconnect.
Archives for November 20, 2018
Once significantly behind, China begins to close the drug development gap
Moving forward, China will take a more integral role in global drug development, following several regulatory changes designed to accelerate innovation.
Blockchain could solve many challenges facing the clinical trials process: Analyst
Blockchain provides real-time visibility into the entire clinical trial supply chain and has the potential to solve several of the industry’s biggest challenges.
Building a 'better' CRO as sponsors drive industry consolidation
As sponsors drive CROs to consolidate, building a firm the size of Iqvia would take more than 20 years organically, says consultant – who shares the stuff of nightmares (and dreams).
Revised FIH guidelines: AstraZeneca reflects a year later
Sponsors have had to take steps to follow the new EMA guidelines for first-in-human clinical trials, which can pose risk and operational challenges.
Quanterix expands biomarker tech to oncology research
Quanterix is expanding its biomarker technology platform to oncology with the launch of a new test bed for up to 10-plex assays, which will enable drug developers to expedite clinical trials, says CEO.
PE firm brings CROs together, putting assay development and testing under one roof
The PE firm Ampersand Capital Partners has acquired Pacific Biomarkers and is merging the CRO with Neomed-Labs to streamline clinical immunology development.
News in brief
Dr. Reddy’s stock shares rises amid recent US FDA citations
Dr. Reddy’s Laboratories site in Visakhapatnam, India, was issued a Form 483 last month, yet shares rose after a more recent audit where zero observations were noted.
Europe suspends use of Mylan’s Hyderabad-made valsartan
EU authorities have detected NDEA in some batches of Mylan’s valsartan, manufactured in Hyderabad, India.
Pharma Integrates
What will tip the scales towards continuous manufacturing?
A closer partnership between CDMOs and pharma companies could share the risk of innovation, suggested one pharma director.
New Iqvia tool provides visibility into informed consent
Iqvia describes the new platform as the marriage of eConsent with an authoring system – giving the clinical trial a framework for transparency and transformational change.
StudyKIK ‘breaks up the pieces’ of clinical trial recruitment
StudyKIK has launched its in-house patient pre-screening service in an aim to ease research site burden following research site feedback.