Clinical Quality Management as a Service
Seamless Quality Management for Comprehensive Compliance
At Lumis, we recognize that managing clinical trials can feel like a complex labyrinth.
We specialize in Clinical Trial Quality Management Systems (QMS) that guide you through each step and make the process as smooth as possible.
Our services ensure compliance at every step of your clinical quality management, tailored to your unique needs. Whether you’re building a new QMS from scratch, seeking a seasoned partner to evaluate your processes, or conducting vendor and CRO audits, we’ve got you covered.
Our team of experts, with deep skillsets in pharmaceutical and medical device development, will support you with aligning all necessary guidelines and regulations for your standard operating procedures, providing a solid framework for regulatory review. We’ll assess your needs and vision to deliver customized solutions that fit your project and company requirements – always with a sharp focus on budget and resources.
For over 10 years, Lumis has been delivering top-notch customer service and expertise. We’re dedicated to supporting small and medium-sized biopharmaceutical and medical device companies and pride ourselves on becoming your trusted partner in quality management.
Our 3E Advantage: Expertise. Efficiency. Expedited.
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Tailored QM Systems
Stay guided and compliant at every step, aligned with guidelines and your vision.
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Inspection Readiness
Be prepared for inspections at any stage of the project with a consistent framework.
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Outsourcing Readiness
Accelerate issue resolution and gain confidence in sponsor qualification & oversight.
Clinical Quality Management as a Service
Our small, agile organization is perfectly suited to support small and medium-sized biotech and medical device companies. We customize our services and approach to fit your specific needs.
With deep expertise in Clinical Quality Management, Quality Management Systems for clinical trials, CRO and CRI audits, plus vendor qualification, we work together to create a seamless quality management system that ensures comprehensive compliance.
QMS Setup and Optimization
Your QMS is crucial for regulatory approval and must reflect your company’s scope of activities. At Lumis, we understand that your QMS also needs to align with your company’s structure, vision, and scope.
Here’s how we can help:
- In-depth analysis of your status: We start by assessing your existing QMS or understanding your planned quality management activities.
- SOP revision and development: We review and update existing SOPs to meet current guidelines, create new SOPs for changing or expanding activities or supply essential SOPs if none exist.
CRO Audits/Vendor Qualification and Interim Audits
Choosing the right CRO or vendor can make or break your clinical trial. A qualification audit isn’t just a regulatory requirement– it gives you the confidence you need in your CRO or vendor selection.
Here’s how we can help:
- CRO audit/vendor qualification audits: organize and conduct audits, either remotely or in person.
- Interim audits: organize and manage interim audits during ongoing clinical trials.
- Corrective and Preventive Actions (CAPA): provide detailed reports and follow-up.
Site Audits
As a sponsor of the clinical trial, you are responsible for qualifying the participating clinical sites. Regular onsite audits improve quality and compliance at these sites.
Here’s how we can help:
- Audit plan development: create comprehensive audit plans
- Remote or onsite audits: prepare and organize reports and CAPA
- Audit certification: accompany you through the audit certification process
Contact us to find out more!
