June 16th 2025
Navigating a complex drug development landscape, sponsors must rethink their approach to risk in study design and execution.
C-Suite Survey Underscores Digital Technology’s Growing Role in Clinical Trials
August 19th 2020Findings from the most recent Biopharma Confidence Index show that the pandemic has substantially influenced biopharma executives’ expectations in key areas like artificial intelligence/machine learning and real-world evidence.
Decentralized Trials: Opening New Opportunities in Clinical Research
August 4th 2020Rasmus Hogreffe, former Head of Virtual Trials at LEO Innovation Lab, and current VP of Decentralized Trial Innovation at Medable, and Morten Kirkegaard, Head of Clinical Operations and Co-founder at REDO-neurosystems, discuss their experiences with decentralized trials.
FDA Policies Support Shift to Decentralized Clinical Trials
February 8th 2019FDA Commissioner Scott Gottlieb supports approaches that help biomedical research “become more agile and efficient” and reduce the cost of developing therapies, including decentralized trials and how real world data (RWD) and real world evidence (RWE) to support a range of drug development goals.
Future Directions of Cancer Immunotherapy in Clinical Trials
June 20th 2016Progress and innovation within oncology has accelerated to a paradigm that includes immunotherapy and bio-genomics. Collaborative approaches in the future will continue to transform treatments in hopes of improving patient quality of life.
Long-term Electrocardiographic Monitoring: Time to Rethink What We Know?
February 22nd 2016With significant technology advances in ECG recording through the years, the need to expand on traditional monitoring baselines-and include new variables such as time when designing clinical trial protocols-is important.
Rare Diseases: Meeting the Unique Challenges of Orphan Drug Development
January 21st 2016Poor understanding of the natural history of the proposed indication due to few observational studies studying disease progression, heterogeneous patient populations with variable phenotypes and clinical courses, geographic dispersion of patients and investigators, regulatory uncertainties, and lack of prior clinical studies to establish a template for study execution, can all prove challenging in creating a pharmaceutical development program for the treatment of a rare disease.
Designing Alzheimer’s Disease Clinical Trials For Success
September 8th 2015Alzheimer’s disease (AD) is and will remain one of the most unyielding public health crises of the 21st century. Aging global populations translate to a constantly growing prevalence of a disease with no cure and an immense cost of care. In the United States alone, recent estimates1 suggest that 28 million people will develop AD by midcentury. Approximately 25% of the annual Medicare budget will be spent treating the disease – a projected $330B in 2040 – with hundreds of billions more in indirect costs.
Quintiles' Phase I Unit Tackles Trial 'Shopping'
August 14th 2015Clinical trial recruitment and enrollment has presented its challenges in many ways. For Quintiles’ Phase I Unit in Kansas, clinical trial recruitment was a matter of process and strategy that it improved with innovation and mobile health (mHealth) technology applications. This article and case study will delineate the challenges that Quintiles’ Phase I Unit underwent, and what it did to achieve transformative results in recruitment, study visit adherence, and operational efficiency.