Feb 09, 2016
Reactive, hastily enforced regulations can easily jeopardize the sound conduct of a clinical trial and its data flow, potentially threatening both subject safety and data quality.
Feb 04, 2016
With the initial promise of immunotherapy use in oncology, we need to continue supporting cross-industry collaborations among leaders from the biopharma community, academia, regulators, and private sector investors.
Feb 01, 2016
EU authorities have been keeping up a constant flow of reminders of just how valuable research programs are–not just in terms of scientific results, but in terms of what the funding can do for improving industry's capacity to innovate.
Jan 21, 2016
mHealth is making a strong case for its ability to optimize clinical trials and improve engagement with participants and patients.
Jan 19, 2016
Applied Clinical Trials
Recently introduced changes to China's drug review and approval process—aimed at reducing the country's significant regulatory submission backlog—will have implications in large areas of drug development.
Jan 19, 2016
Telling signs from U.S., Russia, Latin America and UK indicate that governments are squeezing as much value as possible out of their spending on pills and procedures.
Jan 19, 2016
When paying and reimbursing clinical research volunteers for study participation, what can be done to make the experience more patient centric?
Jan 15, 2016
As in other needs in the clinical trials chain, endpoint adjudication is an area that can be greatly improved by technology.
Jan 08, 2016
Although only the beginning of an exploratory process, the EMA is being accused of colluding in a conspiracy to favor drug firms at the expense of patient protection.
Jan 05, 2016
Califf tackles the many challenges to finding a balance between clinical trials large enough to assess all relevant populations and small enough to include deep data on each patient.
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