Quality Assurance

Audit Plans

The quality of a clinical trial depends on data integrity and the assurance of subject’s protection. With the globalization to developing countries, the outsourcing and the complexity of clinical trials, reaching quality has become challenging. It is therefore essential for a Sponsor to develop quality systems during the planning stages of clinical trials. The quality system requirements include: personnel role and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention and reporting, and Corrective And Preventive Actions (CAPA). Such systems require the development and implementation of standards for each step.

An audit plan should be prepared beforehand and based on results of the risk-based assessment of the protocol and the Sponsor’s written auditing procedures.

At San.K.Bio Consulting, we can support you on developing and updating the audit plan of your clinical study.

GCP Site Audits

The audit of a clinical study is an important element of GCP and is independent of and separate from monitoring and quality control functions. Its purpose is to evaluate trial conduct and compliance with the protocol, SOPs, GCP, and the applicable regulatory requirements.

The Quality of a clinical study depends in particular on how the investigational site conducts the study. Monitoring is not enough to ensure the site’s quality. FDA warning letters and EMA inspections cite monitoring deficiency as the most frequent finding. Therefore, GCP audit of the investigational site is an indispensable step in ensuring a high-quality standard of the clinical study.

At San.K.Bio Consulting, we can perform GCP investigational site audits anywhere in the world.

CAPA Management

Corrective and preventive action (CAPA, also called corrective action/preventive action or simply corrective action) consists of improvements to an organization’s processes taken to eliminate causes of non-conformities/non-compliance or other undesirable situations. With recent issue of ICH E6(R2), if noncompliance that significantly affects or has the potential to significantly affect human subject protection or reliability of trial results is discovered, the Sponsor should perform a root-cause analysis and implement appropriate corrective and preventive action.

At San.K.Bio Consulting, we can support your company on CAPA writing and on the identification of root causes. We have followed-up and worked on + 100 CAPA.

Our GCP Auditor is certified. The training she received was FDA and BIMO inspections-focused.