news roundup
TrialAssure, a provider of clinical trial disclosure and reporting software, is offering its TrialAssure Academic Pricing (TAP) to assist universities with disclosure compliance by giving them reduced rates to its TrialAssure Registry.
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WIRB-Copernicus Group's (WCG) Clinical Services Division has acquired the Velos eResearch business line, which is a clinical trial management system (CTMS) primarily used in institutions and academia.
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Introducing Cross-Trial LMS: A Simple, Efficient, and Intuitive Way to Send Bulk Training
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Articles
At the end of 2018, the FDA released a draft framework for a new Real-World Evidence (RWE) Program, which will help guide generation of data in support of approval for new indications or to help support post-approval study requirements for both drugs and biologics.
How the eClinical Forum's eSource Readiness Assessment (eSRA) tool can be used for assessing and documenting the compliance of EHR systems with regulations and guidance documents. Further allowing research sites, EHR system vendors, and sponsors to determine if data from a healthcare system are appropriate for use as source for clinical research.
Blog Posts
Peter O'Donnell interviews Ingrid Klingmann, chair of EFGCP, about changing the industry and its stakeholders to refocus its approach to give greater priority to the interests of trial participants.
When study sites are juggling between several studies and find it challenging to keep track of monitoring actions and resolving them, these processes and tools can help sites with managing the reports.
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