Services

ESC Elisabeth Scheidl Consulting provides tailor-made and flexible solutions for your quality and compliance management systems. ESC provides experience-based outlines and conceptual designs for a lean and practical quality management system that meets the requirements of daily practice and application.

  • Clinical Trials
  • ICH GCP
  • Quality Assurance
  • Auditing
  • Quality Management Systems
  • Written procedures and SOPs
  • Compliance Management Systems
  • Personal Data Protection & GDPR tailored to Clinical Research
  • All services are tailored and flexible to meet customer needs
  • High-quality and comprehensive QA services
  • Guidance and support to ensure compliance with ICH, GCP, GDPR and other regulatory requirements
  • Preparation and advice to ensure inspection readiness of trials, personnel and relevant processes
  • Audits of processes and systems that are relevant for the successful execution of clinical trials
  • Provision of services of an outsourced data protection officer (DPO) acc. to GDPR
  • Creation and set-up of an efficient and risk-based Quality Management System (QMS) for Clinical Trials
  • Creation and revision of respective SOPs and other written instructions
  • Creation and set-up of an efficient Compliance Management System (CMS) relevant for Clinical Trials, including implementation of a robust process to manage potential compliance risks
  • Creation and set-up of processes to support compliance with GDPR in clinical trials throughout all relevant aspects, i.e., contracting, data collection, processing and storage, data protection awareness trainings etc.
  • Guidance and support for senior management to make robust decisions in QA- and compliance-related questions and topics
  • Assessment of already existing QMS including proposed possible improvements of QMS and support in implementing those changes as well as troubleshooting in case of potentially emerging quality issues
  • Audits of processes and system that are relevant for the successful execution of clinical trials:
    • Investigator Site Audits
    • Vendor qualification audits for clinical providers (e.g., CROs, imaging facilities, archives), including audits of clinical safety laboratories as requested
    • Document audits of relevant essential documents, such as trial protocol, patient informed consent, clinical trial report, etc., and the Trial Master File (TMF) before, during the trial and/or prior to long-term archiving
  • Inspection Readiness Visits at investigator sites and internal mock inspections
  • Training of personnel in ICH GCP E6 (latest version)
  • Training on quality expectations and compliance in clinical trials
  • Training on Inspection Readiness
  • Training on Data Protection Awareness and Compliance with focus on EU GDPR in Clinical Trials
  • Other trainings as required in above-mentioned topics

Could these services be tailored to suit my needs?

ESC Elisabeth Scheidl Consulting offers personalized and adaptable solutions to enhance your quality and compliance management systems.

Characteristics of typical clients who would benefit from the services of ESC Elisabeth Scheidl Consulting can be found here:

CLIENTS
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