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.
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.
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?
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.
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.
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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.
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.
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?