GxP Audits

Clinmark has vast experience in clinical research quality oversite visits, GCP and For-Cause Audits globally. We perform GCP and cGLP, CRO, Site and Laboratory audits and qualifications on a regular basis. We have audited most of global CROs as well as dozens local and regional organizations.

We work collaboratively with our clients to create a beneficial working relationship that allows us to provide appropriate, customized clinical trial auditing support, and assistance in the development of Clinical Quality Assurance (CQA) programs and infrastructure.

The independent audit gives the objective insight into the clinical research projects and provides objective information about credibility/ compliance of the research data and efficacy of operational processes including project monitoring and management, safety, data processing. Clinmark’s experts have extensive knowledge and experience in all aspects related to quality management and quality assurance with the requirements of GMP, GDP, GLP. Regulatory inspections of clinical trials are an integral part of pharmaceutical industry life. Clinmark’s professionals support Clients in the preparation to the inspection and lead them through the regulatory inspections. Our expertise consists of a pre-inspection gap and weaknesses identification in the research processes and research documentation, mock inspection of investigational sites and Sponsors’ departments, training of investigators and Sponsor’s staff, hosting the inspection on Sponsor behalf, preparation of responses to inspection observations and finally, the implementation of CAPAs. Clinmark offers comprehensive support for preparation for GxP inspection tailored to the needs and expectations of a client. The GxP audits are conducted by Clinmark’s experienced auditors. Receiving EU GMP Certification is highly valuable for companies, because it gives them a competitive advantage and confirms, that they manufacture compliant high-quality drugs. Clinmark performs GMP audits at several plants around the world to ensure compliance with GMP guidelines and covers a lot of products.

Clinmark has possibilities to perform all above mentioned services in over 60 countries of the world by very experienced and professional auditors.

Program Examples

Clinmark’s last audit program covers 60 GCP Audits at investigational sites across the Western, Central, Eastern Europe and CIS countries, with 14 different Protocols, realized within 9 months.

  •  16 audits in regions: South America (Brazil), United States, CIS (Russia, Ukraine, Georgia) and Europe
  •  CRO audit projects in: India, South Africa, Singapore, France, Hungary, Germany, Belgium, UK, Italy, Russia, Ukraine, Slovakia
  •  Program of qualification and re-qualification of BA/BE and Phase I CROs (clinical research sites and bioanalytical laboratories) in Czech Republic, Portugal and Jordan
  •  Over 50 audits worldwide for a French Biotech, required and committed after EMA inspection
  •  GMP qualification audit for Central Lab with CAPA management

GCP Audits

Quality assurance plays an important role in the clinical research. The independent audit gives the objective insight into the clinical research projects and provides objective information about credibility/compliance of the research data and efficacy of operational processes including project monitoring and management, safety, data processing. Our GCP audit service includes audits of investigational sites, project management, data management, TMF and vendors.

GMP and GDP Audits

Our consultants have extensive knowledge and experience in all aspects related to quality management and quality assurance with the requirements of GMP, GDP.  We can assist you in:

  •  preliminary audit and analysis of Quality Assurance System documents
  •  elaboration and implementation of necessary documentation of Quality Assurance System according to Good Distribution Practice
  •  audit of technical documentation, elaboration and implementation of Validation Policy
  •  transport cost analysis, profitability of transport routes
  •  performing of GMP audits of medicinal products manufacturing plants

GVP Audits

Clinmark provides independent consultancy and pharmaceutical auditing in the area of Good Vigilance Practice (GVP), providing assurance of compliance with ICH and relevant global regulatory requirements. Clinmark’s auditors have a perfect understanding of the regulatory requirements. That’s why they can deliver first-hand experience on Competent Authority expectations.

GLP and GcLP Audits

Our GLP and GcLP team has the experience and capability to conduct audits of all types including facilities, process data, study specific data and reports against GLP requirements.

GLP Services

Non-clinical laboratory audits of animal or non-animal facilities:

  •  Facility audits
  •  Study audits
  •  Critical or in-process phase inspection
  •  Protocol audits
  •  Data audits
  •  Report audits
  •  Procedure/process audits
  •  Bioanalytical laboratory audits
  •  Mock inspections
  •  Document reviews
  •  Archive audits
  •  Qualification or requalification audits ⦁ Subcontractor and Vendor Inspections

GcLP Services

Audits of clinical and bioanalytical laboratories that process human samples for safety parameters, biomarkers, other specialty analyses, bioequivalence etc.

  •  Facility audits
  •  Study audits
  •  Protocol audits
  •  Data audits
  •  Procedure/process audits
  •  Report audits
  •  Mock inspections
  •  Document reviews
  •  Archive audits
  •  Qualification or requalification audits
  •  Subcontractor and Vendor Inspections
  •  GcLP gap analysis
  •  Training of clinical staff in the requirements of GLP and GCP (GcLP)

Vendor Qualification Audits

Using third party vendors to provide specialized services for the clinical trial is a significant consideration. Contracted services (for instance analyzing trial samples or providing repository for the documentation) require appropriate qualification prior to the management throughout the clinical study. Clinmark has a lot of qualified vendors in a database we can refer to. Clinmark can meet Customer’s clinical research auditing needs across all types of vendors. Our auditors offering independent auditing services can assist you with vendor selection, assessment and even ongoing management.

System Audits

Relationship between Sponsor and third-party vendors are essential for the success of a clinical study. Clinmark assists in selecting the vendors and qualifying them by performing System Audits. Our auditors assess and qualify the sites and vendors according to quality compliance, procedure adherence and other relevant requirements. By conducting system audit we provide assurance that all procedures have been carried out. Additionally, we check whether company and regulatory expectation have been fulfilled.

ISO 13485 Audits

ISO 13485 specifies requirements for a Quality Management System for organizations required to demonstrate its ability to provide medical devices that consistently meet Client and regulatory requirements.

ISO 13485 is the most accepted global standard of its kind and will bring your business a host of benefits, including:

  •  Full ISO 13485 compliance – which is fast becoming a prerequisite for regulatory authorities everywhere
  •  Be confident that your company has a quality system that meets the demands of legislation in every corner of the global market
  •  ISO 13485 will establish robust development, manufacture, distribution and control processes
  •  The standard will help to optimize efficiency and minimize costs
  •  ISO 13485 will also help you to monitor your supply chain so that you are always in control

ISO 14155 Audits

ISO 14155 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.

The principles set forth in ISO 14155:2011 also apply to all other clinical investigations and should be followed as far as possible, depending on the nature of the clinical investigation and the requirements of national regulations.

Clinmark Auditors have broad experience in auditing Medical Device clinical trials. We can support your project by giving independent overview of quality at your research sites, and when required, provide practical recommendations on how to correct identified nonconformities, improve or optimize the study processes.

Our auditors perform also trainings on ISO 14155 – see section training and development.

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