Why Symbiance Quality Assurance and Quality Controls
At Symbiance, Quality Assurance (QA) is an integrated practice that promotes excellence by ensuring adherence to our processes. Our focus on quality has been honed by years of specialized data analysis and management and a thorough grasp of Good Clinical Practices (GCP) and FDA requirements and processes. Every client benefits from our QA experience in disciplines including clinical data management, biostatistics and SAS® programming.
Procedural Quality Assurance Controls
Symbiance’s procedural QA process involves periodic review of programming standards (program structure, notation, unit testing and electronic filing of programs). Our scientific Quality Control (QC) process involves reviewing the scientific integrity of the analyses to ensure the consistency of the Protocol vs. SAS® databases vs. SAP vs. statistical results. Upon project closure, our QA process assesses compliance with corporate and study-specific SOPs.
Our quality assurance process provides vital guidance to the medical writing department. Our medical writers incorporate a QC function into every document preparation process and complete review and QA cycles for each interim and final deliverable Symbiance produces.
Risk Assessment Strategy
As part of QA controls, within our transition plan, we conduct a risk assessment program and develop a contingency plan. Elements include:
- anticipated risk
- root cause
- mitigation steps
- contingency steps.
We start by envisioning failure and barriers to success and listing out factors (risks) that could lead to failure. For each perceived risk we:
- outline potential root causes (there may be several)
- identify steps to prevent risk from occuring
- if risk does occur, what steps can then be taken (contingency plan).
