“It is not enough to do your best; you must know what to do, and then do your best.” - Edwards Deming
There are different factors behind corporate success. Continuous improvement, the ability to adjust to business environment and market trends are the qualities of a modern, effective organization. Clinmark can help to develop your business. Our consultants have a unique combination of business, operational and research quality standards expertise. We can support you in planning research programs and projects, the optimization of research processes, vendor selection, oversight of the project execution, project quality measures, risk assessment and risk mitigation plans. Due diligence evaluation, regulatory inspection, tutoring and operational expansion to new territories are key elements of Clinmark’s consulting services.
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 in particular 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
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 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.
Non-clinical laboratory audits of animal or non-animal facilities:
Critical or in-process phase inspections
Bioanalytical laboratory audits
Qualification or requalification audits ⦁ Subcontractor and Vendor Inspections
Audits of clinical and bioanalytical laboratories that process human samples for safety parameters, biomarkers, other specialty analyses, bioequivalence etc.
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 number 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.
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 minimise 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.
Regulatory inspections of clinical trials are an integral part of pharmaceutical industry life. FDA and EU drug regulations require from the drug license owners to collect and submit information on efficacy and safety of their products, but also give the authorities the right to inspect the information provided. Clinmark’s professionals have helped our clients many times to get prepared to and successfully go 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 last but not least, the implementation of CAPAs.
Preparation for Regulatory Authorities Inspection
Clinmark offers comperehensive 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.
Standard Operating Procedures (SOPs) are written documents or work instructions that detail all of the steps involved in a procedure or process. Part of Clinmark’s consulting offer is devoted to the development or review of SOP system. Clinmark is ready to support you in SOP system development or optimization of the existing one. The SOP development services include end-to-end level mapping of process and formatting SOPs to your template and organization structures.
Part of Clinmark’s consulting offer is devoted to the development or review of SOP system. Clinmark is ready to support you in SOP system development or optimization of the existing one.
Scientific and Medical Affairs (Scientific Advice)
Clinmark has the expertise to support your clinical studies from the initial concept considerations
through protocol design and development, protocol feasibility considerations, site selection input, medical monitoring, regional Key Opinion Leader identification, up to regulatory submission.
Our highly qualified medical and scientific affairs team is ready to collaborate in the following areas:
Product Clinical Development Plan
Protocol Design Thinking
Study Documents Development & Medical Writing
Medical Monitoring & Data Review
Study Results Description & Presentation
Veterinary Clinical Trials
Veterinary clinical trials are research studies that test the safety and effectiveness of new approaches to healthcare. With each study, we answer questions that help us find better ways to diagnose, prevent, and treat diseases. Veterinary clinical trials often also compare a new treatment to an existing one, allowing us to find the best treatments available. Finally, veterinary clinical trials allow us to evaluate new treatments for diseases in animals that also occur in humans.
Clinmark provides full-service solutions for veterinary studies in all therapeutic areas with each study undergoing a customized approach and oriented on the preparation of our customers for their success.
Clinmark’s professionals have become experts in the area of clinical trials process optimization owing to a large number of conducted international research projects, audits and consulting services. We are keen to share our knowledge and experience with all those who wish to develop in this area.
Our attendees are provided with maximum of practical knowledge based on a thorough understanding of clinical practice. We apply theoretical knowledge of ICH-GCP, regulatory and legal requirements to everyday practice. Therefore, trainees are faced with real problems and case studies while looking for optimal solutions with full help and guidance of our team.
Training For Individuals
Companies that wish to develop skills and competencies of their personnel will find Clinmark’s offer tailored to their needs. We are dedicated to developing training and development programs enabling trainees to gain skills and tools based on individual needs, so that they are able to meet the growing demands of the market and the needs of their team, providing good results with the emphasis on efficiency in their projects.
Development Programs For Business
Based on the extensive consulting experience and knowledge gained during a vast number of audits, we have prepared a unique offer as a response to the growing need of support in functioning and development of clinical trial departments. The education and development programs are based on trials conducted by R & D in your company, guiding members of the team or the entire department through the development process, supporting standard training provided by the organization significantly streamlining skills and tools.
In the course of a few months of regular meetings, participants can learn how to optimize the process of conducting research at every stage, learn to properly prioritize their duties and responsibilities, increase their efficiency during monitoring visits improving the skills essential to preparation of monitoring visit reports, problem solving in research sites and risk identification at an early stage of a project.