The medical device industry has to cope with highly similar regulations as pharmaceuticals. High levels of evidence are mandatory with respect to precision, efficacy and safety of diagnostic and therapeutic interventions.
Our activities comply with all applicable GxP and similar quality requirements and we support our clients from design, project management, monitoring, analysis, reporting until final publication:
Preclinical and clinical research for all development stages
IT support for laboratory automation, documentation and evaluations
Evidence based medicine and diagnostics evaluations
Marketing support studies, surveys and seeding projects
Desk research, design and management of surveys
Evaluation of economic aspects
Our special sample size minimising designs and evaluation methods imply huge savings of time and money!