Quality Assurance

Good Clinical Practice (GCP) is the ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials. Compliance with GCP ensures the protection of patients’ rights and confidentiality. It also ensures credible and accurate reporting of data.

Quality assurance services

Our CQA department can support your clinical development projects with consultation, auditing and training to ensure compliance with GCP and other legal requirements.

We can help you with the following audits:

• Site audits  pre-inspections
• SMF/TMF audits
• Document audits (clinical study protocol/report)
• Vendor – sub contractor audit
• Database audits
• Standard Operating Procedures (sop) writing
• Quality Management support
• Clinical Quality Audits

We provide training in the following areas:

• Declaration of Helsinki
• Good Clinical Practice (GCP)
• Other legal requirements

A+ Science has unique expertise in Quality Management, especially regarding training and consultation in Good Clinical Practice.