Standard Operating Procedures
PMK operates with own developed SOPs for Quality Assurance of clinical trials phases I to IV as well as SOPs and checklists for system audits and audits of data bases, computer systems, biopharmacy, validation of automated GMP processes (H/W, S/W, machinery, cleaning etc.).

Our SOPs describe all types of Audit Procedures:

 Preparation of Audit Schedules

 System Audit (clin research departments, CROs, SOP compilations, validation of computer systems, phase I facilities, central laboratories)

 Pre-Trial Audit: Study documents (protocol, CRF, Patient Informed Consent)

 In-house Audit: Trial Master File and Project Management at the Sponsor/CRO

 On-site Audit: Trial center, laboratory, pharmacy

 Database Audit: Biometry, computer system validation

 Clinical Trial Report Audit: check of the Final Report on compliance with ICH Topic E 3, completeness, consistency, compliance with the protocol, typographic errors etc.

 Audit certificate (Quality Assurance Statement)

Detailed checklists will be used for all these types of audits of clinical trials or system audits.

Complete SOPs may be provided and implemented for all tasks and/or the infrastructure for planning, performance and evaluation of clinical trials (Sponsor/CRO: organizational structure, study planning, ethics, monitoring, drug handling, AE/SAE/ADR reporting, data entry and data handling, data verification, data base closing, method validation, statistical analysis and final report).