Explore ARG’s Quality Assurance services.Tell Us About Your Study
Every project is approached with clinical curiosity by asking, “What is important here in this particular study?
100% review of each ICSR, from source document analysis to query generation, and everything in between.
Formal review of each subject to ensure they meet inclusion/exclusion criteria prior to study enrollment.
Review of data listings to ensure accurate data is collected and improves subject safety by monitoring for signals.
Review of TLF mock-ups to proactively identify and mitigate potential issues, using our understanding of study data.
Review of coded terms to produce clean, consistent data, enabling timely database lock and better data representation.
ARG QA is able to customize and deliver a custom solution because the department has a diverse range of skills from training to regulatory compliance to GLP. Additionally, our integrated approach to QA means we are involved not only from an audit perspective but from beginning of the study through the end.
When the coronavirus pandemic restricted travel, sponsors needed a way to evaluate potential CROs via prequalification and maintenance audits without having to visit them in person.
ARG was challenged with responding to this need quickly. We needed to develop a solution to perform seamless, reliable remote audits.
ARG’s QA department created a way to host sponsor audits remotely. Through our industry-leading tools and technologies, we set up secured shared drives and hosted meetings, which included opening, closing, and interviews with staff, via teleconference.
We also made our QA team available throughout each audit, just as we would during in-person reviews. Questions were answered right away, and documentation was uploaded to the shared drive throughout the audit.
ARG was able to complete many successful remote audits during the pandemic, and still today. Sponsors continue to inquire about remote auditing services. We provide our solution that enables a successful experience from start to finish.