PRA International Plans to Open New BioAnalytical Laboratory
In October of this year, PRA International plans to open their new Bioanalytical Laboratory facility, located in close proximity to PRA's U.S. based Phase I Clinic in Lenexa, Kansas. This facility will be equipped with state-of-the-art LC/MS/MS equipment.
Currently PRA has a Bioanalytical Laboratory facility located in Assen, The Netherlands. This is a GLP-compliant laboratory began operating in the mid 1980's. The facility's analytical capabilities include:
- Equipment for mass spectrometry
- Ultra performance liquid chromatography
- Biomarkers
- Biochemistry & immunochemistry
- Radioisotope analysis
- Handling of biohazard samples
Newsletter
Stay current in clinical research with Applied Clinical Trials, providing expert insights, regulatory updates, and practical strategies for successful clinical trial design and execution.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
FDA Issues Complete Response Letter to Replimune for RP1 Combination Therapy in Advanced Melanoma
July 22nd 2025The FDA’s complete response letter cited concerns that the Phase I/II IGNYTE (NCT03767348) trial in advanced melanoma was not an adequate, well-controlled study and that its heterogeneous patient population limited interpretability, preventing approval in its current form.
