Quality Control (QC) in Clinical Research

MMS provides QC as a service (QCAS) on documents we author, or as a stand-alone service. We employ a robust QC process that operates effectively or can be adapted to meet Sponsor-specific requirements. This design ensures the accuracy and consistency of data within any clinical or scientific document.

Additionally, we check documents against templates and style guides for proper formatting and style points. Using our proven method, we can QC any clinical, non-clinical, or scientific document quickly and efficiently. Our deep expertise in QCing medical writing deliverables expands across nearly all therapeutic areas.

The MMS QC Group has expertise in a broad range of regulatory documents, including:

• Core documents, such as clinical study protocols, informed consent forms (ICF), clinical study reports (CSR), aggregate reports and common technical document (CTD) modules
• Less common documents, such as briefing packages and responses to global health authority questions
• Unique documents provided by Sponsors that need bespoke QC review

MMS is flexible across numerous times zones. With team members across India, South Africa, and the US, we can accommodate tight timelines and short notice. Our team meets daily to properly resource the best fit team member for each document type or therapeutic area.

We have the ability to train and grow new team members quickly to accommodate a growing number of requests.

To further improve your experience with MMS’ QC service, we have developed a QC web portal to allow you to book your standalone QCs using unique login credentials issued to you by MMS IT. Requesting your standalone QCs through the portal is fast and simple, gives you complete visibility of your current and past requests, ability to check on the status of ongoing QCs or edit your requests in any way, upload new sources and documents for QC, and download your completed QC files from the portal.

The portal sends you notification email at s at each step of the process to keep you actively appraised of the QC’s progress, including one when the QC is complete which contains a download link so that you don’t need to visit the portal to collect your QCd document, should you choose.

The portal is secure so that only you can see your QCs, and anyone at your institution with portal credentials can view all of your institution’s requests.

If you are an MMS client and are interested in our standalone QC service and would like a demonstration of the portal, please speak with your MMS project manager, who will be happy to arrange that for you.