Best practices for rapid test development and regulatory approvals.
A strategy to reduce potential conflicts when working with clinical research study stakeholders.
Using anatomic pathology for biomarker development in clinical trials can help predict and assess how a patient will respond to immuno-oncology therapies
Questions and concerns as the FDA prepares to develop and implement a program evaluating the potential use of Real World Evidence (RWE) for regulatory decisions.
Three essential things for data managers to look for - and for technology providers like us to deliver - as clinical trial technology becomes more prevalent and diverse.
Advances in precision medicine lead to new trends in immunotherapy.
Overcoming hurdles in a regulated setting.
Five areas to investigate to determine whether your site is ready based on the 2016 FDA-OHRP guidance about eConsents.
This article highlights some of the monitoring challenges and burdens related to informed consent for a clinical trial and explains how electronic informed consent (eConsent) can positively impact monitoring practices and documentation. The article demonstrates how oversight of data integrity and human subject protection may be improved with an eConsent solution and provides some guidance on considerations when implementing eConsent in a clinical trial to enhance the monitoring process, including saving time, reducing costs and boosting efficiencies.
Are studies focusing on elderly cancer patients at increased risk for discontinuation due to safety reasons, such as toxicity?
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