QUALITY ASSURANCE
Managing Quality in the clinical trial process is essential to ensure data integrity and participant safety. TASK’s quality team oversees and ensures that the highest standard of quality is adhered to according to good clinical practice (GCP) and international standards from study set up to study close out.
Our QA team has experience in Quality Management Systems (QMS) across all phases of clinical trials and a variety of therapeutic areas. We have worked with a range of clients from small start-ups to global multinational companies and are flexible with our approach.
Whether you are a clinical research site that needs support in the conduct of your trial or in need of an audit preparation at your site or, you are a Sponsor or CRO that needs to delegate responsibility for Quality Management of your trial or needs to conduct a once off independent GCP audit at a site- TASK Quality has the resources and knowhow to assist with :
Developing and implementing a new QMS at the site or audit a current QMS, then report on required amendments and detail a roadmap to compliance.
Independent risk analysis of the protocol
Drafting of a Monitoring Plan
Contracting independent CRA’s
Management and quality oversight of contracted CRA’
Conducting independent audits on selected third party vendors g) Conducts independent audits on the sponsor trial master file (TMF)
Conducting independent ICH and SA GCP audits
