Having the right specialists on their team enables Premier Research to recruit subjects relatively quickly, despite extremely complex selection criteria for this multiple myeloma clinical trial. In addition, maintaining a close and cooperative customer relationship assisted in moving the study forward.
A trans-Atlantic study to evaluate an antibody for treatment of B-cell non-Hodgkins lymphoma overcame patient recruiting challenges and has already succeeded beyond expectations in the form of five patients declared disease-free a year and counting while still three years from completing patient follow-up.
For decades, drugs were approved without being tested on women or factoring in whether women would have different reactions or require different dosages than men. Attitudes around involving women in clinical trials have evolved significantly in the past 25 years, however, despite new expectations from regulators pushing for women to be involved in studies, parity has yet to be achieved.
Patient-centricity has been a growing trend across the pharmaceutical and biotech industries for some time now. As the focus on precision and personalized medicine continues to increase, sponsors are looking for innovative ways to increase patient enrollment and compliance while reducing drug development timelines and costs. The direct-to-patient (DTP) model has emerged as a potential solution. This model illustrates a means by which a patient is able to receive his or her medication in the convenience of their home. In this article, we’ll share the top three challenges many sponsors face, and how a direct-to-patient pharmacy can provide solutions.
Recruitment is one of the things sites and sponsors just do. Everyone thinks they know what it means. But it’s so much more complicated than they imagine.
When conducting complex dermatology clinical trials with difficult to treat, rare, or complicated skin conditions, the study’s success or failure can often hinge on the relationship between the PI and patients. Learn what to look for in a dermatology study investigator.
The ability to adapt is a valued attribute in today’s constantly changing world, and clinical trial designs are no exception. Adaptive trial designs can save sponsors significant time and money, but they need to be approached with caution and planning.
As a leader in women’s health research, Health Decisions has extensive experience in recruitment of female subjects for trials in a variety of indications, including but not limited to women-specific indications. Health Decisions is pleased to share some lessons from our experience in women’s health studies to assist sponsors in increasing female participation in studies across the therapeutic spectrum.
Adaptive design strategies have been especially useful for rare disease research in general and rare oncology in particular. Read more to see how the savvy application of adaptive trial design compares to conventional study designs.
Speed to Study™ accelerates your trial while maximizing flexibility so you can get the data you need faster.
Biorasi’s Neurology and Regenerative Medicine Center of Excellence has become a leader in this evolving field. Our expert team, combined with Biorasi’s close relationship with sites worldwide and access to diverse and hard-to-find patient populations, allow us to guide neurology, pain, psychiatric, and cell therapy trials to success.
The only solution that offers both ride and reimbursement automation within one portal.
Exposure (and Dose) Response Analyses, including pharmacokinetic and pharmacodynamics analyses, guide critical decisions in drug development. Cytel’s expert Quantitative Pharmacology and Pharmacometrics group delivers high quality solutions to help our customers get those decisions right.
When time-reduction, cost-savings, quality and reliability matter, ropack pharma solutions is the distribution partner positioned to deliver.