Clients
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:
For quality assurance, consultancy and training
- Small and medium-sized companies for QA consulting that cannot/do not want to afford full-time QA
- Biotech start-ups and academic spin-offs, with a limited experience and know-how of the regulatory requirements as an R&D company
- Companies that are moving from preclinical to clinical (i.e., the development product enters the clinical development phase after testing in the laboratory (in vitro) and in animal testing (in vivo), i.e., first administration to humans (first-in-human (FIH))
- Service providers who offer relevant services for conducting clinical studies as a sub-area and therefore cannot/do not want to afford full-time QA with a focus on GCP (e.g., data management, monitoring)
- Service providers who only offer their clinical trial services as part of their main business and therefore cannot/do not want to afford full-time QA with a focus on GCP (e.g., imaging facilities, laboratories, archives)
For auditing services
- All companies in the research-based pharmaceutical industry that issue audits to external auditors (outsourcing)
- Agencies that provide external auditors to customers in the pharmaceutical industry
FAQ
Clinical trials are systematic surveys that play an important role in evidence-based medicine and clinical research. They are carried out in patients or healthy volunteers in a highly regulated environment.
According to EU Regulation No. 536/2014 Art. 2(2), the aim of clinical studies is to determine the effectiveness and/or safety of the tested drugs. These studies are conducted to answer scientific questions in medicine and to improve available medical treatment.
Clinical trials are a prerequisite for official drug approval and corresponding market entry.
The conduct of clinical trials is described in the international guideline of the International Council for Harmonization on Good Clinical Practice (ICH GCP E6(R2)). This guideline is enshrined in national legislation as a binding standard and can be found as a reference in the valid provisions (e.g. national pharmaceutical laws, EU Regulation No. 536/2014 Art 2(30)). The definitions and standards described are therefore recognized and applied globally.
The description of the importance of the quality assurance measures from ICH GCP E6(R2) is used as standard in the industry and therefore the implementation of a quality management system in all phases of the trial process is essential to ensure that clinical trials are carried out and data are generated, documented and reported in accordance with the trial protocol, Good Clinical Practice (GCP) and applicable regulatory requirements.
An audit (according to Good Clinical Practice ICH GCP E6(R2)) is a systematic and independent examination of process-related activities and documents to determine whether the evaluated trial-related activities were carried out and whether the data were recorded, analyzed and accurately reported in accordance with the trial protocol and sponsor’s standard operating procedures (SOPs).
Furthermore, the qualifications of an auditor in Good Clinical Practice ICH GCP E6(R2) are defined as follows:
Only individuals independent of the clinical site and other systems conducting the clinical trial should be appointed as auditors, and it should be ensured that auditors are qualified by training and experience to properly conduct audits.
More information about my qualifications
Over 20 years of experience in clinical research, operational activities and quality assurance.
Further information about myself, my education and achievements can be found here: