In addition to careful adherence with all applicable regulatory and Customs requirements, sponsors should understand and be sensitive to the cultural and business norms of each country included in their study.
Improving outcomes in clinical trials and reducing the trend toward high placebo response across different therapeutic areas requires the involvement of multiple stakeholders.
Learn about the latest healthcare technologies and standards, including what they can and cannot do, to streamline patient access to your specialty therapy. New technologies can significantly reduce the time to fill, and increase patient adherence with your specialty medication.
In this paper, some of our thought-leaders provide their insights on what they are watching for and what they anticipate in 2018 in clinical trial technology, regulatory changes, and scientific developments.
Increasingly central in the course of drug development is the inclusion of observational studies, including registries, which provide insights missing from traditional interventional studies.
This white paper discusses the role of the pharmacy in a modern day Phase I clinical research unit and its role in understanding the safety and pharmacology of a drug before Phase II can begin.
Follow these tips to avoid the overuse of edit checks and build better studies.
It is up to pharmaceutical companies sponsoring clinical trials in the EU to have complete control of their supply chain. Understanding recent changes to the EU GDP guidelines can help achieve this as they now offer a more comprehensive guidance for temperature management during storage and transportation.
While Andexanet Alfa’s Breakthrough Designation added additional stress to the supply chain, Portola and Sherpa navigated these issues by devising fast, flexible and responsive approaches to supply chain management.
For methodological reasons, patient-centric study engagement and retention solutions appropriate for clinical trials may not always be suitable for real-world studies.
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