Quality

Medpole has its own Standard Operating Procedures that comply with ISO14155 and ICH-GCP regulations. Alternatively, Medpole can use your company SOP’s for conducting your clinical trials. We are working according to the highest quality standards, applicable to clinical research:

· CPMP/ICH/135/95, Note for guidance on GCP

· EU Directive (2001/20/EG)

· Medical Device Directive (93/42/ECC)

· Applicable regulatory requirements

Medpole also provides auditing services in compliance with GCP. Audits are performed on study documentation, in-house and at the study sites. We maintain high quality by performing regular internal processes audit.