ArcheMedX’s new digital platform aims to reduce the risks and costs associated with underperforming clinical trials by analyzing the behavior of project teams and site personnel.
The MA-based CRO Veristat is partnering with Triumph Research Intelligence to provide centralized and risk-based monitoring solutions to improve clinical trial compliance.
Comprehend, a clinical intelligence software company, has packaged its clinical trial risk detection and management service offerings to accommodate the needs of mid-sized CROs.
Firms should identify risks prior to inspection, make staff available during regulator visits, and respond promptly post-inspection when undergoing GMP site checks, says Ireland’s Health Products Regulatory Authority (HPRA).
For the third year in a row, about 30% of Deloitte poll respondents say their companies experienced supply chain fraud, waste, or abuse in the previous year.
TransCelerate’s new RBM (risk-based monitoring) methodology focuses on the use of technology and centralized monitoring to shift away from Source Data Verification (SDV) to risk-driven monitoring, according to two papers in the Drug Information Association's Therapeutic...
Three years after Pfizer began strategic partnerships with CROs Icon and Parexel, and the companies are still ironing out differences and tweaking their relationships, Mark Sanders, senior director of global sourcing, told attendees at DIA’s annual conference.
Sponsors are piling on more responsibilities for their CRO partners, but the question of how that will translate into increases in risk and profit sharing is a point of contention.
CROs and sponsors that apply a risk-based algorithm to monitoring clinical study sites could reduce the deployment of research associates and target more high-risk patients and sites, according to a new report from PricewaterhouseCoopers (PwC).
Takeda says it will help Nihon Pharmaceuticals bring manufacturing operations up to code after Japanese regulators order the CMO to halt production and recall one lot of its vitamin B1 shot.
ADC Biotechnology (ADC Bio) has secured a development grant for a new antibody drug conjugate (ADC) manufacturing technology that, it says, can make drug production cheaper.
The ICH has approved a revision to its genotoxicity testing and data interpretation guidelines that it says will improve risk assessment and reduce the number of animals used during preclinical development.
The EMA says current GCP rules make quality management in trials too costly and need to be revised into a code that meets the needs of academics, small and midsized drugmakers and Big Pharmas alike.
Pall Life Sciences has launched its Allegro 3D biocontainers, which have been designed to improve the performance of the company’s large-scale, single use manufacturing systems.
Harro Hofliger’s adoption of the FMEA-Med software will help the German machining specialist minimize risk during development operations, according to Canadian developer Dyadem.
The rise of the biotechnology industry is set to create additional
pressure on pharmaceutical companies, who already have to deal with
unreasonable expectations, where even common molecule failure in
the R&D stages result in loss...
