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....
Expertise: Clinical Development 108 results
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...
Clinical Development
Premier Research Comes on Strong in Clinical Researcher of the Year Competition
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...
Clinical Development
Premier Research Receives Magazine’s 2018 CRO Leadership Award
DURHAM, N.C., APRIL 27, 2018 — Premier Research has been named a 2018 CRO Leadership Award winner by Life Science Leader magazine. The publication annually asks pharmaceutical and biopharma companies to rate the capability and performance of contract research organizations....
Clinical Development
ICH GCP Update: Sponsor Control of Clinical Trial Data
Under the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP), sponsors have extensive responsibilities for ensuring not only the ethical and scientific quality of clinical trials, but also the...
Clinical Development
Updates to the ICH GCP (Good Clinical Practice) Guidelines: Quick Review
First produced in June 1996, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) is an internationally agreed standard that ensures ethical and scientific quality in designing, recording and...
Clinical Development
ICH GCP E6 (R2): A Primer for Small Biotech and Specialty Pharma Companies
Recent updates to the ICH Good Clinical Practice guidelines call for implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting that are intended to increase clinical trial quality and efficiency while continuing to...