Quality.
Every step.
Investigator site audit
The Phase I to IV studies have different requirement depending on the study structure, and our experienced auditor(s) visit the investigator sites and review their facilities and documents and interview the relevant staff.
Trial Master File (paper TMF or eTMF) audit
The paper Trial Master Files (TMF) or electronic TMF (eTMF) will be reviewed according to the GxP and relevant standards, remotely or on site.
Vendor qualification ; Due diligence
Contracted Research Organisation (CRO) and other vendor (re)qualification, periodical review of the sub-contractors.
Investigator site selection/ qualification
Qualification and periodical review of Early Phase commercial facilities (e.g. Phase I study facilities) and other clinical investigator sites.
CRF design; study data capture workflow review
The design of user interface and data capture fields of study worksheet / CRF defines the workflow hence quality of the data collected during the study. By designing the right CRF/ data worksheet, you will get the right outcome.
Protocol/ Clinical Study Report (CSR) review
Reduce the necessity of frequent protocol amendment by referring to another study instruction documents. What was done and analysed in the study should be clearly documented in the CSR, disclosing any ‘compromise’.
Archiving process review
Do you ‘test’ your document retrieval process? The item retrieval and the safe storage in the warehouse will be checked.
Quality Management System (QMS)
Migrating from paper-based QMS to electronic system involves a careful planning and attention to details. Once implemented, an electronic QMS will reduce the paperwork and streamline the workflow.
SOP development
Developing the SOPs requires a technical understanding of how the process works. Let us help you to organise and update the ‘controlled documents.’
Regulatory inspection support
MHRA (UK), FDA (US), PMDA (Japan) inspection support are available. Our QA personnel explain the differences between the inspection workflows by the different regulators, and help prepare the ‘scenario’ to manage the ‘potential’ responses to the inspectors’ questions.
GMP licensed local pharmacy review
The compounding facility or ‘injectable’ handling facility in the hospital that will provide the drugs to the investigator sites will be visited; any Investigational Medicinal Products (IMP) management or accountability and their documentation will be reviewed.
Good Manufacturing Practice (GMP)
Local Investigational Medicinal Products (IMP) handling facilities and transfer/ disposal of IMPs will be reviewed.
Let’s make it work together.
Clinical Trial QA 