We Understand Your QA Challenges:
- Does your CRO perform internal quality audits of their own departments?
- Does your CRO include dedicated QA personnel on their study teams?
- Does your CRO’s QA department have input to all aspects of your project from study plans to database review?
- Does your CRO have the capabilities to allow for remote audits?
- Does your CRO understand the evolving complexities and regulations as a result of Covid-19?
Infusing quality and integrity from study start-up to close-out to ensure straightforward submissions
ARG QA believes in the science of quality. This principle is realized by the performance of consistent, essential activities: good procedures, targeted QC and relevant audits. ARG considers the quality of everything we do as paramount to the value of your study. Patient safety and data integrity are vital considerations, especially when patients are hard to find and every one matters.
ARG’s QA team has experience running clinical studies in both the US and ROW, with team members averaging over 20 years of experience.QA is involved in all aspects of the study, and as a result, there is always one dedicated QA person on each study team, available to answer quality and regulatory questions. We pride ourselves in this type of integrated approach, going way beyond performing a few audits and administering CAPAs.
Our aspiration is to identify potential issues and resolve them before they reach critical points, thus ensuring the study runs smoothly from beginning to end. Driven by quality and integrity, our QA team ensures nothing but the best for your project.
"Our motto: ‘Everyone Deserves to be Well’ drives my passion for my job."
“ARG QA is able to customize and deliver exactly what our clients are looking for. One reason is our experience, as 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.”
Main Quality Assurance Offerings
Audit of the documentation and procedures performed at the clinical site. This assures the sponsor that the clinical site is adhering to the study protocol and all applicable regulations.
Audit of the documentation contained in the Trial Master File, ensuring that the TMF is always ready for an regulatory inspection and that it adheres to the project plan and GCP.
Prequalification or maintenance audit of documentation and services provided by a vendor, verifying that either the vendors have the processes and procedures in place to be able to perform the services needed for the study (prequalification); and/or the vendor is performing the services per the study protocol and applicable regulations throughout the contract period (maintenance).
Computer Validation Audits
Audit of all documentation that is generated during the validation of a computer system, making sure the system is compliant with all applicable regulations.
Audit of the documentation associated with a database lock, ensuring that the proper procedures have been performed prior to locking the data at the end of a study.
The ARG Difference
Internal Process Audits
Most companies have internal audits; however, ARG focuses on ensuring that each department at ARG is paying attention to quality standards of their job. For sponsors, this means that at ARG, quality matters for all aspects of a study at all levels.
Routine Training File Audits
The ARG difference is that we perform these on an annual basis for all employees, hence this process ensures that the training documentation uploaded to TMF is up-to-date (demonstrating that the personnel working on their study are qualified to do so).
The ARG approach allows for better oversight for audits/inspections. ARG QA is the administrator of all training, which allows for better oversight during an audit/inspection. Our training ensures that the personnel working on studies are properly qualified and prepared.
These audits capture manageable sections of the study, which allows our team to proactively solve issues rather than scrambling at the end. The value to sponsors is that these audits save both time and expense, and ensure that every part of the study process is performed correctly.
Quality Gap Analysis
Gap analysis helps to identify areas where processes/procedures may be lacking or not strong enough to meet quality standards. We are different because this is not something typically offered by other CROs. We are able to assess and assist a sponsor to identify where there are gaps before an audit/inspection which in turn can save them time, money and potentially inspection findings.
Regulatory Inspection Readiness
Similar to site audits, this service focuses on how to help a site or sponsor get ready for a regulatory inspection. ARG QA provides insight on what to expect, reviews basic documentation, and assists in any other aspects of preparation. Readiness is not something typically offered by other CROs. This type of audit can be invaluable to an inexperienced site or sponsor, averting inspection findings and potentially saving time and money.
Remote Audits During Challenging Times
Clinical trials are expensive and time-consuming, so it is important that a sponsor have absolute confidence in the CRO they are entrusting to perform services and manage their trials. In order to feel such assurance, a sponsor quite often performs prequalification or maintenance audits of the CRO. During a pandemic with limited travel, sponsors still needed a solution to be able to perform these necessary audits. The challenge for ARG was to provide seamless and reliable remote audit capacity.
QA has hosted multiple remote sponsor audits within the last year. Through the use of our industry-leading tools and technologies, ARG was able to set up secured shared drives for uploading documents for an auditor to review. Meetings, which include opening, closing, and interviews with staff, were hosted via teleconference. ARG’s QA department was available throughout the whole process, just as if the audit was conducted in-house. Questions were answered right away, and any further documentation needed was uploaded to the shared drive throughout the audit. Remote auditing saves travel time and expenses, and clearly can continue regardless of outside challenges.
Unlike an in-house audit where the auditor is limited in the time they spend at ARG, a remote audit grants the auditor access to the shared drive for a longer designated period, which can be beneficial. In addition, the sponsor saves on the expense of travel for the auditor to our facilities. A trend is developing, where sponsors are consistently inquiring about remote auditing. With the ways in which clinical trials (and quality assurance) are conducted potentially shifting as a result of the global pandemic, ARG continues to lead the way in terms of remote service offerings.