For developers seeking to obtain approval for previously approved drug products in the United States, the U.S. Food and Drug Administration (FDA) offers two abbreviated approval pathways — an abbreviated new drug application (ANDA) and a 505(b)(2) application. Both of these applications rely on the agency’s finding of safety and effectiveness for a listed drug,…
In a survey conducted by Informa Pharma Intelligence on behalf of Oracle Health Sciences, 76 percent of respondents indicated that the pandemic hastened their adoption of decentralized clinical trial (DCT) approaches. While the shift to DCTs is well underway, concerns remain around patient monitoring and engagement and data reliability and quality. In particular, nearly half…
MORRISVILLE, N.C., April 16, 2021 — Premier Research, the clinical research company that’s Built for BiotechTM, is proud to recognize Victoria Watts, Vice President, Privacy and Global Data Protection Officer, for her key role in developing the European CRO Foundation (EUCROF) GDPR Code of Conduct for Clinical Research Service Providers, which was submitted to the…
Traditionally, Phase 1 trials commonly utilize 3+3 designs to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D). Studies have shown, however, that two out of three trials employing a 3+3 design failed in identifying the MTD, and better approaches are needed.1 During Premier Research’s recent webinar Alternative Designs to the…
Developing a new biopharmaceutical product is a lengthy, high-stakes journey. It takes, on average, at least 10 years and over $2 billion to successfully bring a new drug to market, and only 10% to 15% of products ultimately receive regulatory approval.[1] A comprehensive plan and the right regulatory and therapeutic expertise can significantly accelerate the…
Pandemic-related disruptions have accelerated much-needed change in clinical operations, but this change has been accompanied by questions about data collection and data quality. In a recent survey commissioned by Oracle Health Sciences, more than 75 percent of industry respondents indicated that limitations in patients’ ability to attend on-site visits sped up their adoption of decentralized…
The ultimate goal of any drug development program is to obtain regulatory approval with the desired prescribing information. Beyond that, developers hope to obtain this approval in the shortest amount of time and with the most efficient use of resources. In an article published in Trends in Biotechnology,1 researchers found that the approved drugs and…
Conducting clinical trials of therapeutics and devices can be daunting, and COVID-19 has made this endeavor even more challenging. With the emergence of this pandemic, sponsors and CROs have been tasked with adapting processes, technologies, and training to move studies forward in a dynamic, demanding environment where regulations continue to evolve. For global studies, this…
CRO Leadership Awards Recognize Clinical Research Organizations That Meet or Exceed Customer Expectations DURHAM, N.C., May 1, 2020 — Premier Research, the clinical research company that delivers outcome-focused insights which support sponsors in developing life-changing therapies, has been recognized as a 2020 CRO Leadership Award winner in the Life Science Leader program’s “Quality (Overall)” category…
DURHAM, N.C., March 30, 2018 — Fourteen Premier Research employees have been named finalists for PharmaTimes magazine’s Clinical Researcher of the Year awards. The finalists are three clinical trial managers, two project managers, and nine members of two project teams. Competition continues through to April 27, when the awards are announced. The annual awards recognize the…
