“Patient centricity” has long been a guiding principle of clinical trial design and conduct, and it has become even more critical in the COVID era as trial sponsors and regulatory authorities have had to adapt to a continually shifting landscape....
Expertise: Clinical Development 119 results
Clinical Development
Pharmaceutical Outsourcing: Optimizing Study Execution for Advanced Therapies
Advanced therapies – including gene-, cell-, and tissue-based products – offer groundbreaking new opportunities for the treatment of disease. As of the end of 2020, there were 1,085 active developers of these therapies and 152 ongoing Phase 3 trials worldwide....
Clinical Development
Premier Research Names Jennifer Nezzer Vice President of Biometrics
Morrisville, N.C., September 2, 2021 — Premier Research has appointed Jennifer Nezzer, M.S., as Vice President of Biometrics. Nezzer, an industry-recognized expert in biostatistics with more than 25 years of global clinical research experience, will head Premier’s integrated Biostatistics and...
Clinical Development
International Clinical Trials: How Contingency Plans Became the New Normal
Over the last decade, there has been increasing interest in mobile health (mHealth) and wearables. The general population has been tracking their steps, checking their heart rates, and monitoring their sleep patterns. Meanwhile, the clinical trial industry has been exploring...
Clinical Development
Premier Research Acquires Specialty Women’s Health and Diagnostics CRO
Morrisville, N.C., July 20, 2021 — Premier Research today announced that it has acquired Health Decisions, a Durham, N.C.-based contract research organization (CRO) focused on clinical development in all areas of women’s health and diagnostics. Premier Research is a leading...
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...
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...