We have a quality assurance team dedicated to the support and coordination of research activities at global and local level.
- All of our research is conducted in accordance with the ethical principles set out by the Declaration of Helsinki.
- Our processes are managed and controlled by specific Standard Operating Procedures, implemented to improve the coordination between all stakeholders involved in research activity at a local and global level, to guarantee data protection and privacy and to consistently enhance our quality output.
- For our clinical research services, we strictly follow the principles of the International Conference on Harmonization (ICH) and guidelines for Good Clinical Practice (GCP) and we act in accordance to the applicable local regulatory requirements.
- We are committed to protect animal welfare as much as possible. We apply the 3Rs principles (Replacement, Reduction and Refinement) so that we contribute towards limiting the number of animals used in testing.
- We work with hospitals, laboratories and research partners that have standards in place for quality compliance in conducting: clinical trials, laboratory analysis (GLP), monitoring, reporting, storing as required by any local standards and certified by local authorities.
SPRIM ADVANCED LIFE SCIENCES is certified ISO 9001:2015, and our research service is compliant with:
- ISO 14155:2011:Clinical investigation of medical devices for human subjects Good clinical practice
- ISO 10993-1:2006 ‘Biological Evaluation of Medical Devices – Part 1: Evaluation and testing’
- ISO 10993-2:2006 ‘Biological Evaluation of Medical Devices – Part 2: Animal welfare requirements’
We are also able to provide support for medical device standardisation. We have a network of expertise who are compliant with:
- ISO 10555-1:2013
- ISO 10555-3:2013
- ISO 10555-4:2013
- ISO 10555-5:2013
Click here to see the certificate.