GCP/GLP Auditing

Independent audit of the pre-clinical trials for drug registration and of the clinical trials conducted during drug development is essential for the registration process of a new medical product. Having the required experience and knowledge AdWare Research conducts study specific audit for all phases of pre-clinical and clinical studies and system specific audits according to Good Clinical Practice (GCP) and Good Laboratory Practice (GLP).

GCP (Good Clinical Practice) audits

GCP audit means a regular and independent assessment of the trial related documents and activities, with the aim of ensuring the respect of subjects’ right, safety and well-being and to guarantee the credibility of clinical data. GCP audits assess the compliance of the client’s activities with the SOPs and relevant regulatory requirements.

In a study specific audit, depending on the size and scale of the selected study one or more procedures are examined. The audit includes assessment of the study plan, the study sites, and the procedures of data processing. The study plan, patients’ information sheet, CRF and final report are examined to ensure accuracy and consistency.

In a system audit, an assessment of the organisation is conducted to determine whether it meets the requirements of GCP and applicable laws or regulations. We examine the system for proper planning, supervision and documentation necessary to ensure that the trials are conducted according to the SOPs.

Services offered by AdWare Research cover all aspects of GCP and are customised to clients’ needs. We provide:

  • Investigator site audit
  • Phase I audit
  • Assessment audit of CROs
  • Clinical laboratory audit
  • Database audit
  • Clinical report audit
  • Training
  • SOPs
  • Support and consultancy

GLP (Good Laboratory Practice) audits

Accurate and reliable results can be achieved only in right laboratory conditions. This is guaranteed by GLP rules and by GLP based audit.

AdWare Research makes GLP investigations according to 9/2001. (III. 30.) EüM-FVM on “Good Laboratory Practice regulation and “OECD Principles of Good Laboratory Practices (ENV/MC/CHEM(98)17)”.
The aim of the audit can be:

  1. Control of a particular study,
  2. Control of a particular study site,
  3. Audit of the methods and procedures.
  1. Control of a particular study contains the following:
    • audit of the study protocol,
    • audit of the study sites in order to determine whether the trials are done according to the GLP regulations,
    • audit of the final report. As a part of the final report a signed, attested declaration is made that contains the type, date and phase of the audit and the date when the report was sent to the management; it states that the report is based on raw data.
  2. Control of a particular study site means an investigation to supervise whether the laboratory meets the requirements of the GLP.
  3. During audit of the methods and procedures AdWare Research makes sure that everything is done according to the previously accepted SOPs.

Every audit ends with a final report in which the divergences are documented.

We provide:

  • Training
  • SOPs
  • Support and consultancy