All articles by Hiriyti Bairu

Hiriyti Bairu

How to effectively incorporate PROMs in oncology trials

With a growing number of sponsors including patient-reported outcomes (PRO) data to support clinical trial endpoints, it is vital for the industry to keep up with the evolving regulatory landscape for clinical research studies.

Scale management: What do sponsors and CROs need to consider?

Sponsors and contract research organisations (CROs) face several challenges related to the identification, acquisition, translation, and implementation of clinical rating scales. Careful, early planning and partnering with experts in scale management can mitigate their impact and ensure the success of a study.

How electronic clinical outcome assessments improve clinical trial evidence generation

With clinical research sponsors collecting an increasing amount of clinical data, it is vital that outcomes measures collected are reliable and can support accurate decision making. How can electronic methods of capturing data help?

Serialization readiness: the path towards compliance

As the pharma industry gears up for the FDA’s new requirements, third-party logistic providers will play a key role in helping manufacturers establish a serialization strategy in the early stages of drug development.

How serialization will shape the future of the pharma industry

Jeff Primeau, vice president of business solutions for ICS, explains the challenges and opportunities for manufacturers implementing serialization and the role serialization will play in the future of the pharma industry.

How CATs can enhance clinical trials

While patient-reported outcome measures (PROMs) in clinical trials may, in some cases, require a high quantity of questions to be answered by participants, computerised adaptive tests (CATs) can benefit patients by reducing the burden of completing them.

New US serialization requirements: how will they impact the pharma supply chain?

As new serialization requirements come into force later this year, they pose significant challenges for companies along the pharma and biotech supply chain.

Harnessing decentralised methods for trial optimisation

Decentralising a clinical trial can optimise the way they are run – with speed, accuracy, and a focus on ensuring an empathetic patient experience – as well as optimise how clinical evidence is collected.

How pharma manufacturers can make their supply chains more resilient

In part one of a five-part series, ICS experts explore one of the key questions that manufacturers should ask when deciding whether a third-party logistics provider (3PL) is the right choice for their business: What does the right experience look like in 2023?