Revised study now includes the opportunity to demonstrate the cardiac safety of a new drug by utilizing Exposure-QT response study data in dose escalation and other studies.
Study start-up has significant impact on the overall speed of a trial, making it one of the most critical parts of the study process. Encouragingly, adoption of study start-up applications is on the rise. Discover the top areas for improvement in today's study start-up processes.
Public health and medical research occasionally take unexpected turns that allow us to glimpse new wonders into the world we inhabit. After the scientific community had accepted Pasteur’s germ theory of disease, discoveries in microbiology increased exponentially, including Robert Koch’s use of agar in 1876 as a culture medium to isolate specific micro-organisms.
It is difficult to quantify the soft costs of managing a clinical trial. One factor guilty of contributing to spiraling soft costs is time. Download Almac’s case study that demonstrates how Almac’s One Clinical Trial Supply Solution helped a pharmaceutical company streamline its clinical trial operations, resulting in time and cost savings.
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.
Unsure if a REMS is needed during product development? This article will answer that question and give guidance if implementing a REMS is necessary.
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.
From researchers to sponsors to patients to advocacy groups to clinicians, in rare disease research all people involved must be utilized to their greatest potential for a study to be successful. Learn more about the operational challenges within rare disease research and how to overcome them.
CNS trials especially can become mired down and derailed by a too-low enrollment rate. Read how using a patient network and identifying sites that best fit the needs of the trial can help overcome this challenge.
Secondary packaging is a critical component to patient adherence. From the overall design to detailed labeling, it serves to fill information gaps between patient and doctor leading to healthier outcomes.
Clinical trial management and late stage research to achieve regulatory approval and optimize product commercialization
With ample available capacity, Ropack Pharma Solutions provides the efficiency of five bottling lines with quick changeovers, online validated fill accuracy and the flexibility to accommodate small lots to commercial runs for the bottling of tablets, capsules and powders.
Best-in-class processes coupled with industry-leading technology to fight for your trial’s success.