Tag: quality

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 a 2020 CRO Leadership Award winner in the Life Science Leader program’s “Quality (Overall)” category...

Medical and Regulatory Affairs

FDA Releases Draft Guidance for Transdermal Product Development

Transdermal and topical delivery systems (TDS) are important dosage forms that allow delivery of a drug to local tissue or provide systemic delivery through the skin. These drug products provide a number of advantages for patients, but can be challenging to develop. In November 2019, the FDA issued a draft guidance entitled Transdermal and Topical...

Data Management & Biostatistics

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 protection of study participants and the integrity of clinical trial data. The recent update of...