Accelero Bioanalytics provides analytical services for your valuable samples from clinical First-in-Human (phase 0) dose-escalation trials up to global safety and efficacy phase 3 studies.
The test facility operates in compliance with the following regulations:
(1) ICH HARMONISED TRIPARTITE GUIDELINE: Guideline for Good Clinical Practice E6 (R1),
current step 4, June 1998
ICH E6 R1 GCP Guideline
(2) WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI, October 2008
Declaration of Helsinki
(3) Clinical trials - Regulation EU No 536/2014, April 2014
EU No 536/2014
(4) German GCP Directive, October 2012, if applicable
German GCP Directive
Accelero is an analytical laboratory that performs the analysis or evaluation of clinical trial samples in accordance with the EMA Good Clinical Laboratory Practice (GCLP) reflection paper. The facility holds a Good Laboratory Practice (GLP) certificate which covers the analytical and clinical chemistry testing of samples derived from biological test systems. The EMA reflection paper on the guidance for such laboratories (EMA/INS/GCP/532137/2010) basically applies the GLP principles also to the analysis of clinical specimen.
Please also notice the EMA guideline for good clinical practice E6(R2) which was drafted in July 2015.
Especially the document glossary clearly illustrate the differences in the GLP and GCP / GCLP wording.
The U.S. Centers for Medicair and Medicaid Services (CMS) confirmed that - as long as Accelero does not perform human sample analysis for diagnostic purposes - a CLIA certificate is not required.
Last update of this site: 21-OCT-2016 by Christian Lange