Drug safety surveillance, a core focus of clinical trials, can be influenced by subjective judgement, as this analysis of differing expert assessments of adverse drug reactions—and the reasons why—shows.
Pediatric trials now feature increased modeling and analytics for safer drug dosing and response.
Sponsors and their contractors have faced challenges when ensuring that parties involved in global clinical trials adhere to rules and regulations regarding biomedical research. For an effective collaboration to take place, all parties must meet the expectations and accountabilities detailed in the trial contract.
Some in the financial industry have argued that we may be in the midst of another economic recession. The biopharmaceutical industry has shown resiliency during such times and industry trends point to that being the case again.
CDISC Europe Interchange
April 25, 2016 - April 29, 2016 / Vienna, Austria
Managed Access Programs
April 26, 2016 - April 27, 2016 / Munich, Germany
eSource Data in Clinical Investigations
May 02, 2016 - May 03, 2016 / Philadelphia, PA
Clinical Trial Innovation Summit
May 09, 2016 - May 10, 2016 / Boston, MA
Publication & Clinical Trial Disclosure
June 22, 2016 - June 23, 2016 / Barcelona, Spain
A substantial increase in procedure complexity should be reflected in increasing per patient costs of Phase III clinical trials,which is not true from these data.
Study shows sharp reduction in market exclusivity periods for first-in-class treatment entrants.
The number of countries used in commercially sponsored Phase III clinical trials has not changed in recent years.
By Siva Reddy
While thousands of hours are spent in the hopes of finding more effective treatments, many of them are rejected due to administrative errors. These three tips can help reduce the frequency of common administrative mistakes during clinical trials.
Major Depressive Disorder patients display a reduced ability to feel pleasant experiences known as Anhedonia. Such a feature provides difficulties when treating depression and engaging patients during clinical trials.
When considering countries for basing clinical trials, local input should be solicited for issues that could impact the study.
This special report offers an article regarding current FDA thinking and future direction with these assessments. ERT--a cloud platform solutions provider that captures quality efficacy and safety endpoints in centralized Cardiac Safety, Respiratory, Suicide Risk Assessment, and Clinical Outcome Assessments—offers expert view on this regulatory change.
Clinical trials have increased in number and complexity for numerous reasons—global trials, outsourcing, protocol requirements, and multiple regulatory issues. Factor this with the increased need to bring efficiencies and lower prices to the clinical trial process, and the need to stay on top of trials only becomes more crucial. This eBook will include articles on logistics of clinical trials supplies, negotiating with investigative sites, use of e-signatures and more.
Applied Clinical Trials presents the latest issues that have risen to prominence since RBM adoption grows. This edition presents a well-rounded look at RBM including articles that describe current RBM trends; a survey of European CRAs, which shows the difficulties among sites and monitors with RBM; a comprehensive look at how sponsors and CROs can support their employees in the RBM transition, and closes with a case study on Novartis' use of adaptive monitoring.
Catalent Clinical Supply Services enlisted Applied Clinical Trials to develop an eBook that includes the best articles on conducting clinical trials in the Asia-Pacific region. Those articles include: the growing data management services market in China; navigating clinical supply challenges in Asia-Pac regional studies; trends in clinical trials placement, including South Korea as a destination for early phase trials and a look at the future of biosimilars development and steps to develop a logical sourcing strategy. SPONSORED