Quality Control (qc) services in Clinical Research
Detail-oriented QC reviewers who deliver well-formatted,
accurate, and consistent regulatory documents.
Ensuring sponsors’ regulatory documents achieve the highest possible levels of accuracy and
consistency, while conforming to template instructions and regulatory guidance.
QC services at MMS harness innovation and streamline processes to ensure the creation of high-quality documents, delivered on-time with fewer drafts, easing document development for sponsor study teams. With one of the best QC timelines in the industry, a global presence in multiple time zones, and a commitment to quality, you can expect the highest level of satisfaction for every project.
Breadth of Experience
MMS provides QC as a service on documents we author, or as a stand-alone service (QCAS). We employ a robust QC process that can stand alone or be adapted to meet client-specific requirements. It’s designed to ensure the accuracy and consistency of data within any clinical or scientific document. We also 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. We have in depth experience in QCing medical writing deliverables in many therapeutic areas.
The MMS QC Group has expertise in a broad range of regulatory documents, including:
- Core documents such as protocols, informed consent forms, clinical study reports, aggregate reports and common technical document modules
- Less common documents such as briefing packages and responses to health authority questions
- Unique documents provided by Sponsors that need bespoke QC checking
Global Quality Control Team Presence
Our team is very flexible, 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. QC is mostly conducted in India, but QC leads are available in South African and US time zones to provide additional capacity and flexibility for this service. When requested by sponsors, triaging of documents to the India team takes place in the region where documents are authored. Our global QC team presence allows handling of urgent requests in 24-hour global QC coverage.
Standard Quality Control Workflow
Once we receive a QC request from a sponsor, our QC team triages documents and confirms instructions and sources. Then we complete the QC according to the sponsor’s request. Our team then queries for missing sources or seeks clarification as needed. Upon QC completion the final deliverables will be sent to the sponsor and we can provide QC completion certificates if required.
Many sponsors choose MMS as their QC provider, and this outsourcing approach provides a number of benefits. Each sponsor, we partner with to provide a QC service is assigned an overall QC lead who develops an in-depth understanding of the sponsor-specific requirements, investigational drugs, and therapeutic areas. Our familiarity with writers and team members means enhanced communication during QC. Our ability to identify and communicate trends across document types allows for improvement in authoring and formatting processes over time.
- Data: 100% source document verification as well as the consistency of data throughout the document.
- Style: for formatting, abbreviations, spacing, cross-references, references, and hyperlinking.
- Adherence to templates
- QC Checklists: can be one of the MMS QC document-specific QC checklists, a sponsor QC checklist, or we can work with you to create a bespoke checklist that contains the needed items.
- QC Certificates: Our QA department can provide a QC certificate if required per your processes.
Related Client Case Study
QC Support for FDA-Approved NDA Submission for Rare Disease Therapeutic
MMS supported a large biopharma client with QCing FDA queries about their NDA submission for a rare disease therapeutic. We helped the company complete the projects ahead of time, and the therapeutic was approved by the FDA.
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