Quality Assurance

The Quality Assurance Unit is an independent unit within TFS Trial Form Support (TFS) which ensures the quality of the work provided by TFS by maintaining the quality management system and conducting internal audits to ensure that clinical trials are planned, conducted and reported in compliance with ICH Guidelines, applicable regulatory requirements, the study protocol and applicable Standard Operating Procedures (SOPs).

In addition to providing internal Quality Assurance for all clinical trials, the Quality Assurance unit also provides flexible, stand alone services for clients including, conducting audits and pre-inspections, assisting companies in the development of their own quality management systems, and writing Standard Operating Procedures.

TFS auditors, who are based in Scandinavia, the United Kingdom and Benelux countries have many years clinical research experience and have conducted GCP, GLP and GMP audits in North America, Asia and throughout European countries, including Russia and the Ukraine. TFS Quality Assurance Unit’s main focus is GCP.

Examples of stand alone services provided by the Quality Assurance Unit:

CLINICAL QUALITY AUDITS
TFS auditors conduct all types of Phase I to Phase IV audits worldwide according to TFS or clients standard operating procedures. Audits can be conducted in compliance with TFS or client’s standard operating procedures. After the audit clients are provided with confidential audit reports and certificates. TFS is also able to assist clients with Corrective and Preventive Action (CAPA) process following audits.

Investigator site audits
Single or multi-site audits conducted at any location worldwide.

Document audits
All kinds of document audits, including but not limited to:

• Study Master File
• Clinical Study Protocol
• Case Report Form
• Clinical Study Report

Vendor – sub contractor audits
Audits of all kinds of vendors and sub-contractors, including CROs to ensure that they meet regulatory and client requirements and expectations.

Database audits
Audits to ensure the validity and acceptability of the data in the database.

Clinical Pharmacology Unit audits
Audits of the unit’s facilities and procedures.

PRE-INSPECTIONS
TFS provide all kind of pre-inspection audits for clients.

STANDARD OPERATING PROCEDURES (SOP) WRITING
TFS Quality Assurance unit can write or update Standard Operating Procedures (SOPs) according to client’s specifications. This process can be conducted together with client staff or independently. The Quality Assurance unit can also perform “gap” analysis to identify the need for revisions to existing SOPs or the need for new SOPs.

QUALITY MANAGEMENT SUPPORT
TFS provide support for clients to develop, implement or review existing quality management systems with recommendations for improvement to ensure compliance with regulatory requirements and guidelines, including:

• Clinical Operations
• Biometrics
• Pharmacovigilance
• Quality Assurance