Quality Systems in the pharmaceutical realm was originally effectuated to maintain compliance and oversight within drug manufacturing under Good Manufacturing Practices (GMP). Throughout the years, the quality systems infrastructure has been adapted to the domain of clinical trials under the auspices of Good Clinical Practice (GCP), and referred to as a Clinical Quality System. Clinical Quality Systems address compliance in its entirety; from protocol development to site management and GCP audits to clinical study reports. In essence, the stronger your Clinical Quality System, the more likely your study is to be compliant and able to progress to the next submission phase expeditiously.
Clinical Quality & GCP Services
Our GCP team is made up of subject matter experts in clinical quality and compliance. We can provide the following services and more:
- Clinical Quality System design to include:
- Risk management
- Clinical Quality Manuals and SOPs
- CAPA design and processes
- Clinical Quality System implementation
- GCP qualifying audits for sites and vendors
- GCP audits for ongoing trials, routine and/or for-cause
- Vendor audits including Contract Research Organizations (CROs), Central Labs, IRBs, and Data Management.
- Project Management of audits including end-to-end strategy, document review and system integration.
Benefits of Having a GCP Consultant
The Weinberg Group can provide an array of GCP and clinical quality services to fit your needs. We have a large network of seasoned and qualified auditors with experience in almost every indication. We can expertly and objectively create systems and project plans, and conduct audits as well as manage the entire project on your behalf.
By utilizing our consulting services, you can address the following:
- That a vendor and/or site organization are knowledgeable of, and adhering to, the federal laws and regulations governing clinical trials.
- That the safety, rights, and welfare of trial subjects are being protected.
- That the site and/or vendor have adequate quality systems for trial management and prompt necessary action for matters of non-compliance.
- That trial oversight is adequate, controlled and is conducted according to applicable protocols, standard operating procedures (SOPs), and regulations and guidelines.
The Weinberg Group is your Trusted GCP Compliance Expert.
The Weinberg Group provides quality system design as well as completely independent GCP audits of each of your trial sites and vendors. This can be a daunting task and we can provide comprehensive and services tailored to your unique needs to include:
- Clinical Quality System Design: This generally begins with a gap analysis and thereafter a custom plan of services ranging from SOP writing to building a quality framework.
- Within the scope of a quality system or within your own established system, we can contrive a risk-based methodology for GCP audits for vendors and/or sites using either your audit criteria, our own criteria, or a combination thereof.
- Audit Customization: We spend time with you during the contracting process, understanding exactly how you want the audits conducted and providing a best methods approach based on the trial design.
- Auditor Experience: Our auditors average 10 years of GCP auditing.
- Auditor Qualification: The Weinberg Group has an extensive Auditor Qualification Program. We qualify all of our auditors to ensure a thorough, accurate, and comprehensive audit is conducted on your behalf.
- 100% Quality Control Review: All audit reports are QC reviewed and approved by the Director, GCP services and/or The Weinberg Group’s CEO, ensuring an accurate report, in a timely fashion.
- Professional GCP Management: An experienced project manager will be assigned to your account (at no additional charge).
- Fixed Pricing: The consistency of our auditing process enables us to provide you with a fixed price per audit anywhere in the world.
We charge a single fixed price per On-Site-Audit-Day (OSAD) for our GCP services, regardless of location or type of audit. This price includes all aspects of the audit including pre-audit training, preparation for the audit, travel time to and from the audit site, the audit itself, The Weinberg Group’s QC of the audit report, one review cycle by you, and a teleconference to discuss audit results. Our fixed price includes the dedicated project manager and audit administrative support.
We will work with you to identify the appropriate auditor based on your organizational qualification requirements and needs, ensure the auditor is trained on the audit plan and will then conduct an on-site GCP audit of your clinical site, vendor, quality system, etc. Following an extensive QC review of the audit report, we will provide you with a final GCP audit report.