A leader from the RBQM solutions specialists offers a preview of his SCOPE 2022 presentation on tools suited to decentralized trial design and management.
This year brought the ‘biggest momentum shift’ in the adoption of risk-based approach to trial management in the clinical research industry, says CluePoints executive.
Intraprise Health creates the BluePrint Protect platform designed to solve cybersecurity challenges across the pharmaceutical supply chain as third-party data sharing accelerates.
Deloitte’s acquisition of QSpace expands its IT quality and compliance solutions offering for life sciences firms, including contract research and manufacturing organizations.
With the first deadline for the ICH Q3D guideline on elemental impurities just a few weeks away, pharma companies are still facing some uncertainty about how to comply with the requirements.
European drug manufacturers will have to control the critical aspects of their operations through qualification and validation over the lifecycle of the product and process, according to a new draft GMP guideline from the European Commission.
The ICH says it made progress on its S9 guideline on non-clinical data requirement for late-stage cancer treatments at its most recent steering committee meeting in Missouri, US.
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.
European pharmaceutical and medical authorities have announced
their satisfaction on the progress being made with the European
Risk Management Strategy (ERMS) following a meeting earlier this
month.
A new study by Deloitte Consulting has been developed to help
manufacturers assess the impact that the drive towards
sustainability could have on their business and operations.
