New Tool Enables Premier Teams to Deliver Optimized Country and Site Activation and Patient Recruitment Throughout Duration of Trial Morrisville, N.C., July 9, 2021 — Premier Research, a leading provider of clinical research and development and advisory services to the...
Expertise: Clinical Development 114 results
Clinical Development
ANDA or 505(b)(2): Choosing the Right Abbreviated Approval Pathway for Your Drug
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...
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...
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...
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...
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...
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...
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....
Clinical Development
Managing Pandemic-Related Protocol Deviations: Tips for Clinical Trial Conduct
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...
Clinical Development
Premier Research Recognized as a Top CRO By Life Science Leader
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...