There has been a recent thrust within the pharmaceutical industry to promote the transformation of the clinical trial process.
Recently, Applied Clinical Trials formed a Project Manager Committee, whose members will advise us on matters important for them to succeed in their positions
The concept of increasing the speed and efficiency of clinical trials is a well understood and agreed upon priority of most clinical operations professionals.
An increasing amount of public data on clinical trial research has become available, including ClinicalTrials.gov and Open Payments.
ClinicalTrials.gov is a federally mandated database with a large and growing, number of required data fields. Organizations are required to report any study being conducted under FDA auspices.
Do 50% of US investigators only conduct one clinical trial? Much of the misunderstanding behind this “one time” claim, which first surfaced in the 1990s, rests on a misunderstanding of the BMIS.
Make sure your perspective is heard, and get valuable insights and data for your TMF improvement initiatives
Every trial starts with a budget, and a clinical trial study start-up process that can be fraught with delays. From contract negotiations, to managing a trial for a sponsor, to streamlining study start-up process, this eBook seeks to instruct others on best practices.
With a growing need for post-marketing safety databases, and increased need to collect qualitative information from patients in the pre- and post-market of a drug the evidence gathering from clinical trials onward is expanding.
As acceptance for risk-based monitoring grows, this e-Book examines next steps for sponsors and CROs. This e-Book offers case studies, practical tips, and applications to enhance the effectiveness of a risk-based monitoring strategy.