Having the right specialists on their team enables Premier Research to recruit subjects relatively quickly, despite extremely complex selection criteria for this multiple myeloma clinical trial. In addition, maintaining a close and cooperative customer relationship assisted in moving the study forward.
New research reveals an industry-wide shift towards active TMF management for improved inspection-readiness.
Understand how Metrics provide the foundation for business intelligence for clinical trials, measuring success or failure.
These recent events stressed the importance of the use of an electronic content management system and striving for a paperless environment. Read key take-aways from attendees at these events regarding what the future of TMF could look like.
The special requirements that must be met as the cloud as adopted by life sciences organizations.
An overview of important eTMF knowledge and insights that were shared at the 2018 TMF Summit.
AstraZeneca needed a software tool that could create standardized outputs to streamline communication, save time, and extend the framework with additional features.
Imagine a world where mobile devices allow continuous monitoring of diabetic patients’ blood sugar, cystic fibrosis patients’ breathing, and post-surgical patients’ vital signs – enabling continuous treatment adjustments and alerts to clinicians when emergencies arise. Among the benefits would be better, more personalised, treatment and improved clinical outcomes, with fewer clinic visits and greater independence for patients.
Why would a payer cover an insulin injector that costs patients about $850 more per year than vials of insulin and syringes?. Because, compared to a normal syringe, an insulin injector is significantly safer and easier to use, and therefore leads to fewer complications and better clinical outcomes. This ends up saving patients and physicians money in the long run.
Since it took effect May 25, 2018, the European Union’s General Data Protection Regulation has been reshaping the way data is handled across every industry sector, including clinical research. GDPR contains a number of articles that present unique challenges to the pharmaceutical clinical trials industry. In this blog series, we focus on defining the regulation, on key aspects of GDPR that are relevant to clinical trial professionals, and on providing insight on how CROs can achieve compliance in data handling throughout the clinical trial process.
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