ICH guidelines, GLP compliance and 3R rule... All in one
At PhysioStim, your studies comply with all applicable requirements. PhysioStim’s team has a profound working knowledge of all applicable regulations and requirements, which are integrated in our quality assurance policy.
GLP CRO
- Your GLP CRO for cardiovascular studies
- Quality assurance throughout your entire study
- Quality control at every stage
From 2001, PhysioStim is a GLP-certified CRO (Contract Research Organization). We expertly take care of pharmaceutical & biotech companies for cardiovascular safety studies of their own drugs and compounds. Select the right lead candidates at a preclinical stage or determine early evaluation of compounds able to induce QT-prolongation in a solid quality assurance process, are the main PhysioStim highlights.
GLP Good Laboratory Practice
The GLP quality system was adopted by the Organization for Economic Co-operation and Development (OECD) in 1992, which has enabled the GLP standard to spread to many countries around the world. GLP comprises a set of quality standards that guarantee the uniformity, consistency, reliability, reproducibility, quality and integrity of chemical and pharmaceutical non-clinical safety tests.
PhysioStim, Grade A GLP-certified since 2003
Quality assurance at the core of every study. PhysioStim obtained its first GLP-certification in 2001 (Grade B) from the French AFFSAPS agency (now called ANSM), the National Agency for the Security of Drugs and Health Products. In 2003, our expert team was awarded a grade A classification for our quality policy, which has been confirmed since then at every two years subsequent inspection. PhysioStim’s Grade A quality standards was confirmed at the lastest inspection in March 2018.
Other quality standards - 3R:
- Replace
- Reduce
- Refine
Replace animal studies with other methods. Reduce as many trials as required, as few as possible. Refine, minimize stress of study animals.
The right study model to guarantee excellence, a wide selection for reliable preclinical safety studies
The experts at PhysioStim go beyond standard study guidelines to conduct their safety studies. We provide a wide range of possibilities to conduct both mandatory and complementary studies and help your project move forward. PhysioStim has over 20 years of expertise in developing in vitro and ex vivo models to investigate potential drug-related cardiac adverse effects.