According to the Tufts Center for the Study of Drug Development (Tufts CSDD), nearly half of all clinical studies require substantial—and potentially avoidable—protocol amendments that lengthen timelines and increase costs. Tufts CSDD also notes that more than half of the...
Accelerated by increasing acceptance of decentralized medicine ushered in by the pandemic, the digital therapeutics (DTx) market is rising exponentially. In January 2022, a Research And Markets analysis valued the 2021 global market for DTx at $3.35 billion and estimated...
When sponsors develop drugs and devices specifically for women, they need to create trials that are uniquely female-focused. From protocols and endpoints, to recruiting strategies and messaging, these trials have to take into account the unique needs, expectations and regulatory...
Clinical development is about finding new healthcare solutions that improve patient lives. This starts with identifying what matters most to people as they manage their health and wellbeing. Appropriate use of patient input can help improve development and regulatory decisions....
Our focus on women’s health research means we’re sensitive to the concerns and needs of the female volunteers contemplating clinical trial participation. In order to effectively enroll women, it’s important to acknowledge these volunteers and consider their perspectives in every...
Premier Research is dedicated to helping patients and families around the world overcome the burden of debilitating diseases, such as a cancer diagnosis. Cancer is a leading cause of death for children and adolescents, and there are approximately 300,000 children...
The Electronic Common Technical Document (eCTD) is the standard format for submitting applications, amendments, supplements, and reports to the U.S. Food & Drug Administration (FDA). The eCTD harmonizes the regulatory review process for global drug development, as its structure is...
Gene therapy products are typically designed to achieve therapeutic effect through long-acting or permanent changes in the human body. Due to this extended period of exposure, patients who receive gene therapies may be at increased risk of delayed adverse events....
In an effort to maintain the continuity of our clinical trials during the COVID-19 pandemic, Premier Research is helping customers take steps to safeguard the well-being of patients who were previously expected to go to a medical facility to receive...
In response to the Coronavirus Disease 19 (COVID-19) pandemic, the scientific community, industry, and regulatory agencies are pulling together to facilitate the development of diagnostic tests, drugs, and vaccines to help prevent the spread of the disease. The timelines for...