At ClinTec we are committed to building quality into all our processes through implementing and maintaining a documented Quality System encompassing quality control and quality assurance (ICH GCP §5.1). This Quality System includes effective Standard Operating Procedures (SOPs) and appropriate training of staff to fulfil their role within the organisation.
Compliance with the Quality System is verified through independent Quality Assurance and individually tailored audit programmes ensure the submission of high quality data that meets local and global regulatory requirements.
In addition to a comprehensive internal quality assurance program, the QA department at ClinTec provides stand alone services to support companies during the entire clinical development process. Our focused approach, flexibility and commitment to quality means that you can expect to receive an unprecedented level of service.
Among the clinical quality assurance audits we conduct are;
|•||Trial Master File Audits|
|•||Investigator Site Audits|
|•||Phase I Facility Audits|
|•||Clinical Study Report Audits|
|•||GMP/GCP Audits of Clinical Trial Supply Providers|
Quality needs to be implemented into the clinical trial process well in advance of the first subject enrolled and a robust Quality Management System is the key to a successful program. Let ClinTec assist you to develop, implement and maintain your quality management system and assure the highest standard of compliance with GCP.
Preparing companies for upcoming GCP inspection by competent authorities
- Identifying areas for improvement by comparing actual performance with potential performance
Clinical Trial Directive 2001/20/EC requires a program of inspection to be undertaken by the competent authority in each member state. Outside of the EU, the European Medicines Agency (EMEA) is planning to join the FDA in increasing the number of GCP inspections at clinical trial sites outside North America and Western Europe.
To prepare your company let ClinTec QA perform a "mock" GCP inspection and assist personnel with preparing for, hosting and responding to an inspection.
An understanding of Good Clinical Practice is a pre-requisite for anyone carrying out, or involved with, clinical research and clinical trials. To meet this need, we can provide tailored training courses in the following fields;
Clinical Quality Assurance
Good Clinical Practice
Conducting Clinical Trials
The training courses combine lectures with workshops with an emphasis on interaction and exchange of information. All delegates receive a Certificate of Attendance.
ClinTec QA can assist in developing SOPs for the entire clinical development program in accordance wit the requirements of GCP and client specifications.
ClinTec QA can be a valuable resource in all matters relating to regulatory compliance and clinical quality assurance. Working closely with our clients, we can offer insightful advice on GCP issues and assist our clients in developing a quality strategy to minimise regulatory risk.
A Global Resource
We have the resource to meet all your auditing requirements in Phase I - IV clinical trials and with personnel located in Europe and India, the QA team is flexible enough to provide an individual and personalised service for both locally managed and global projects.
The team have worked with a variety of clients from small start-up companies to global multinational, pharmaceutical and biotechnology firms in over 25 countries. With considerable quality experience, we have the knowledge and expertise to develop and deliver a complete audit program to meet the requirements of a rapidly changing regulatory environment.