Quality Assurance

Are You Looking for Quality Assurance from a CRO that Will...

Welcome input from their QA team on all aspects of your study?

Perform internal quality audits of their own departments?

Respond to evolving complexities and regulations from Covid-19?

Explore ARG’s Quality Assurance services.

Tell Us About Your Study

What do ARG’s Clinical Operations Services Include?

Designated QA Advisor

Every project is approached with clinical curiosity by asking, “What is important here in this particular study?

Vendor Audits

100% review of each ICSR, from source document analysis to query generation, and everything in between.

Site Audits

Formal review of each subject to ensure they meet inclusion/exclusion criteria prior to study enrollment.

Computer Validation Audits

Review of data listings to ensure accurate data is collected and improves subject safety by monitoring for signals.

Trial Master File (TMF) Audits

Review of TLF mock-ups to proactively identify and mitigate potential issues, using our understanding of study data.

Database Audits

Review of coded terms to produce clean, consistent data, enabling timely database lock and better data representation.

Meet ARG’s Quality Assurance Director

Jen Stanislawski

Director, Quality Assurance

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.

Why Trust ARG for Your Quality Assurance Needs?

Company-Wide Focus on Quality Assessment of internal teams to emphasize that quality matters for all aspects of studies.

Patient Safety & Data Security Top considerations, especially when patients are hard to find and every patient matters.

Across-Team Audits Company-wide review to ensure that training documentation uploaded to TMF is up-to-date.

Proactive Problem Solving Mini-process audits of studies conducted regularly to study to anticipate and resolve issues.

Early Gap Identification Gap analyses conducted to identify and strengthen weaknesses before inspections.

Regulatory Inspection Readiness Insight on what to expect, documentations, and assistance with answering questions.

Case Study: Remote Audits During Challenging Times

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.

Want to chat with ARG about your specific quality assurance needs?

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