Examining why newly registered trials have fallen in Central and Eastern Europe, relative to other regions.
Six years ago, our department of a large academic research center was having difficulty enrolling enough subjects in osteoporosis studies. We wanted to expand into a variety of trials and increase the number of participants. Despite our experience and expertise, our enrollments were down. We wondered if the pool of eligible participants was shrinking, if our competition was doing a better job than we were, or if we needed to modify our project management style.
Guidance on the unique challenges presented by electronic outcomes.
Integrating a CTMS and an EMR can provide many benefits for supporting the health care needs of patients.
A systematic approach for early identification of BP effects during development of new drugs.
The reality of risk-based monitoring: history and successful implementation for late phase research.
Clinical research organizations should look to peer-to-peer mentoring for professional development.
In some countries, the participation in clinical trial, is still the only possibility to be treated.
Clinical research organizations should look to peer-to-peer mentoring for professional development.
How new technology can impact cardiac imaging in oncology clinical trials and have broader implications for patient safety.
The reality of risk-based monitoring: history and successful implementation for late phase research.
Sponsor-driven, CRO/recruitment provider collaborations propel cost-efficient study completion.
Health technology assessment is a field of analysis that evaluates the medical, social, ethical, and economic implications of development, diffusion, and use of health technology.
Study results using a quality-by-design method, risk-based monitoring, and real-time direct data entry.
One of the many activities across the clinical development cycle that is non-negotiable is the creation, collection, management, and storage of the documents that are contained in the Trial Master File.
An effective clinical trial is one of the most crucial stages in the creation of a new drug.
The use of RBM may be the only way forward as long as the development of medicines relies on clinical testing.
Clinical research organizations should look to peer-to-peer mentoring for professional development.
Study results using a quality-by-design method, risk-based monitoring, and real-time direct data entry.
IntroductionAfter decades of promise, we have begun to realize the fruit of “-omics” technology. Recent advances in proteomics, genomics and metabolomics have enabled us to understand the molecular basis of disease at both the diagnostic and treatment levels. Equally important, a growing suite of biomarkers now provides predictive value for diagnosis, disease progression and cure/remission.
Differing levels of trust in clinical trials information channels across diverse populations is examined in this research.
One of the many activities across the clinical development cycle that is non-negotiable is the creation, collection, management, and storage of the documents that are contained in the Trial Master File.
A view on redefining key roles across the evolving clinical development landscape.
How one biotech is tackling the unmet need for additional immunotherapies and combination approaches in cancer.
Study results using a quality-by-design method, risk-based monitoring, and real-time direct data entry.