Newsletter | November 16, 2023

11.16.23 -- Research Misconduct Updates For Trial Sponsors


Impact Of Research Misconduct Updates On Clinical Trial Sponsors

The Office of Research Integrity (ORI) has proposed updates to the Public Health Service Policies on research misconduct. Darshan Kulkarni outlines how the proposal should influence sponsors to reevaluate existing trial practices.

Reporting Unexpected Incidents To The IBC

Utilize this comprehensive guide to better understand reportable incidents and the appropriate channels for communication when unforeseen events arise.

Studying The Effects Of Drugs On Driving

For CNS drugs that need assessment of their impact on driving ability, Altasciences offers faster study start-up and lower costs with on-site driving simulators.

Strategic Regulatory Documentation Practice

Learn how this highly experienced and fully dedicated team is improving timeline creation complexities and management, resourcing, document interdependencies, and transmission to health authorities.

Regulatory Affairs And Drug Development Solutions

Discover how offering sponsors end-to-end strategic drug development and technology-enabled regulatory services can help reduce time, cost, and risk, from discovery through post-registration.


Are You An Emerging Biotech? Consider This When Selecting A CRO

Better understand how smaller biotech companies should approach CRO selection and what they should consider before launching their clinical development program.

How The 'Gig Economy' GxP Auditing Model Benefits Trial Sponsors

The gig economy has exploded in popularity over the last decade, thanks in part to the Great Recession. Read along as authors delve into a way to apply the gig economy model to GxP auditing.

Development To Commercialization And Beyond

Explore how a CDMO with global capabilities and flexible solutions can help reduce time-to-market, mitigate supply chain risks, and meet global demands while bringing a product to market.

4 Ways FSP Models Are Being Used To Drive Success

Dive into several case studies where clients have leveraged clinical research services to surmount critical challenges within the industry and accelerate their achievements.

Patient-Focused, Data-Empowered, Delivery-Driven

See how patient access and engagement problems are being solved with data-empowered insights and operational excellence, to deliver faster, higher-quality trials.


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