The CQA Company is the backbone of the Acceler8 Clinical Research. In common with all Acceler8 divisions, its corporate structure facilitates optimum commercial efficiency in helping bring clients’ products to market.
Its Quality Assurance function originally operated solely as an internal resource for Acceler8 sister companies.
This facility maintains the Group’s quality management system, audits internal operations and external suppliers, manages documentation, ensures compliance and provides internal QA training.
The service has been accessible externally for clients with time and budget pressures since 2004.
Our CQA team operate as an internal resource to the organisation whilst these operational personnel are also available to augment sponsor organisations through the provision of external QA support which includes:
- Internal and external audits (GCP, GLP, PV, RMP/REMS and GMP).
- Support for statutory GCP and GMP inspections (e.g FDA, EMEA, MHRA), including pre inspection evaluations, mock interviews, inspection training, development of the post inspection corrective action plan and the completion of the specified action.
- Quality Management System development.
- Review of quality systems and legacy operations.
- Standard Operating Procedure evaluation and generation.
- Process mapping.
- Documentation management.
- Staff training.
- QP services.
The CQA Company does not offer a theoretical approach to Quality Management and reviewing, instead all of our personnel have direct, hands on experience of Clinical Quality Assurance and ICH GxP with the ability to provide a real world insight into the role.
The CQA Company operates under the guidance of a Qualified Person (IMP) and experienced QA professionals from all areas of the pharmaceutical industry including GMP, GDP and GCP.
The Updated Guideline for Good Clinical Practice (GCP), E6 (R2), was adopted by the European Medicine Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) on the 15th December 2016 and has come into effect in Europe on 14th June 2017. The CQA Company has worked with many companies in order to implement the 25 Amendments into their Quality Management System (QMS).
The Amendments update the guidance to include covering Risk Management, Sponsor Oversight and Advances in Clinical Trial technology. If you would like assistance with implementation of the new amendment then The CQA Company can supply the required Gap Analysis, Process mapping, risk management and QMS development services to assist your company to maintain the highest levels of GCP compliance.