All articles by Hiriyti Bairu

How to effectively incorporate PROMs in oncology trials

Clinical Trials Arena spoke to Anthony T. Everhart, MD, FACP; Clinical Vice President at leading evidence generation company, Signant Health,…
Scale management: What do sponsors and CROs need to consider?

When it comes to implementing study-appropriate scales in clinical studies, sponsors often face challenges that can add unexpected time and…
How electronic clinical outcome assessments improve clinical trial evidence generation

Ensuring clinical trial data is of high quality is critical; otherwise failure to do so could impact on endpoint reliability.…
Serialization readiness: the path towards compliance

The Food Drug Administration (FDA) recently introduced a 12-month stabilization period, from November 2023 to November 2024, for the pharmaceutical…
How serialization will shape the future of the pharma industry

Q: What are the key challenges facing the pharmaceutical industry when it comes to implementing serialization regulations?From a technological standpoint,…

How CATs can enhance clinical trials

PROMs are composed of a fixed number of items – that is, a question and its associated response scale. While…
New US serialization requirements: how will they impact the pharma supply chain?

First introduced in 2013 under The Drug Supply Chain Security Act (DSCSA), serialization aims to enable more effective traceability of…
Harnessing decentralised methods for trial optimisation

Decentralising aspects of a clinical trial through enabling certain procedures and assessments to be conducted away from a site is…
How pharma manufacturers can make their supply chains more resilient

With new pharmaceutical logistics providers emerging every day, it can be difficult for a manufacturer to determine which one will…