We organize and manage
We perform both internal and external audits. Clinical study audits by our CRO are called internal audits. If we conduct an audit of a study managed by another organization, it is called external audit, with LABMGMU acting as an independent third-party auditor.
Sponsors need guarantees that the clinical study conducted meets all the requirements. Documents of at least one audit are required for the purpose of a marketing authorization dossier.
For that purpose, we offer our services for the study audit. It contains an audit of one, or more clinical sites. In the course of audit, we give special emphasis to the overall process of clinical study organization, its compliance with the normative requirements and rules.
As our team performs audit of a specific study site, they focus on the clinical study safety, strict compliance with the protocol, management of information (its registration, documentation, interpretation and transmission). The qualifications of the study team members is also evaluated. Such audits may be initial, routine or ad-hoc.
An initial audit is performed at the period of selection of clinical sites. It helps assess the preparedness of the site to take part in the clinical study.
A routine audit can be conducted at any stage of the clinical study. However, it is best to plan it when at least 25 % of the planned study subjects have been enrolled.
An ad-hoc audit may be initiated in some cases. For example, if it becomes known that the majority of the study subjects have been enrolled in one study site. It means that the study success mostly depends on the quality of operations in that site. It would therefore be logical to perform audit of that site to prevent the slightest bias. Also, ad-hoc audit is performed in case of concerns about the quality of work at the specific study site. There some other situations, each case is considered individually.
LABMGMU performs all types of study site audits.
Let’s take a closer look at the procedure. The auditor is legally entitled to review any study related documentation, suitability of premises and equipment, level of knowledge of the protocol and GCP by the study team and many other aspects of the study.
The audit plan and scope is developed and approved by the CT sponsor with account for the number of participants and the risk level, type and complexity of the clinical study, as well as other parameters. When the study sponsor resolves to conduct an audit, it engages parties independent of all clinical trial stakeholders, properly qualified, trained and experienced to conduct the audit.
The LABMGMU Quality Assurance and Control team conducts study audits and site audits. Our team are qualified and experienced in conducting audits.
Audit is a valuable tool for early detection of weak points and deficiencies, define corrective actions. This in turn provides highest level of clinical study and unflawed reputation of the study team and the Sponsor.
A contract research organization, we regularly undergo audits ourselves and initiate them.
It helps us verify and continuously improve the quality of our work.
We have a track record of successful audits by international independent auditors like Formalis and Sunnikan.
Our quality control system is certified under GOST R ISO 9001-2015
We also pay special attention to the legal aspects and consider it important to specify the normative-legal documents regulating the procedures of clinical trial monitoring and audit.
1. Order of the Ministry of Healthcare of the Russian Federation dated April 1, 2016 No 200n On Approval of Regulations for Good Clinical Practice” (hereinafter – Regulations);
2. GOST R 52379-2005 Good Clinical Practice, effective from April 1, 2006 (hereinafter – GCP);
3. Resolution of the Council of the Eurasian Economic Commission of November 3, 2016 No 79 On Approval of Regulations for Good Clinical Practice in the Eurasian Economic Union (hereinafter – EEU Regulations);
4. Resolution of the Council of the Eurasian Economic Commission of November 3, 2016 No 78 On Approval of Regulations for Marketing Authorization and Expertise of Medicinal Drugs for Human Use (hereinafter EEU Regulations No 78)
From the point of view of law and ethics we consider audit to be a key element of the clinical trial. Nobody is perfect, and we are here to prevent faults
Victoria Artiukh, Head of Quality Assurance and Control.