QUALITY & PROCESS MANAGEMENT

Sponsors and CROs worldwide focus on a high quality execution of clinical studies in compliance with all applicable guidelines and laws. A comprehensive quality and process management ensures standardized processes, a high-quality conduction of clinical studies, underpins the validity of the data collected and thus supports the principles required by ICH-GCP

  • Protection of the study participants, 

  • Collection of valid, up-to-date and comprehensive data as well

  • transparency and traceability of the study.

Audits & inspections are becoming more and more important for the selection of sites, as the quality-compliant implementation of clinical trials is becoming more and more important. A well-established quality management including SOPs represent the effective conduction of quality assurance.


Due to our long-term experience in the collaboration with sponsors, CROs and study sites covering a wide range of diverse indications, SIGAL SMS is familiar with the high requirements in clinical research and support you in ensuring your quality standards with a centralized quality management and optimal process management.

 

QUALITY ASSURANCE WITH SOPs (STANDARD OPERATING PROCEDURES)

The implementation of appropriate SOPs (Standard Operating Procedures) ensure the standardized execution of clinical trials, taking into account all current regulations, and are an essential part of audits and inspections. SOPs support your staff and your service providers in their day-to-day work.
 

THE IMPLEMENTATION OF STANDARDIZED PROCESSES SUPPORTS YOU IN…
 
 

USE OUR EXPERTISE IN ALL COMPONENTS OF QUALITY MANAGEMENT - CONTACT US TO IMPLEMENT SUITABLE MEASURES:

  • Creation and revision of SOPs, as well as continuous further development of the documents

  • Preparation and support in carrying out audits and inspections

  • Support in answering audit and inspection reports (including the creation of CAPA plans)