There has been a recent thrust within the pharmaceutical industry to promote the transformation of the clinical trial process.
Many of us speak about the importance of clinical trial data quality and integrity, yet the lack of data quality standards and definitions introduces subjectivity risk in clinical trials.
Type 2 diabetes mellitus is one of the Western world’s most common chronic conditions, with global prevalence increasing rapidly.
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.
Faster go/no-go decisions is the primary driver of adaptive-design adoption by sponsors.
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.