QUALITY MANAGEMENT SYSTEM
QUALITY BY DESIGN
When it comes down to drug development, high quality output is not optional. Our patients trust us to provide them with options that are safe, efficacious and that serve a true purpose…and we can only deliver that if we apply rigorous quality standards throughout the whole lifecycle of drug development.
From a business perspective, the challenge lies on ensuring compliance with the applicable standards/requirements while remaining agile enough to keep the innovation flow at a speedy pace.
At CLINERGY, we understand how hard it is for sites to keep a full quality management structure up and running, particularly when the influx of studies may go down at times. With that in mind, we offer tailored quality management services according to your site’s needs so that you can fully comply with regulations, guidelines and sponsor’s expectations and keep your site on the top of their list.
AN X-RAY OF YOUR SITE´S QMS
With our simple and easy to use Quality Management tools we can quickly understand where your site are in terms of compliance with clinical research quality standards and, from there, act upon opportunities for improvement.
CONTINUED SUPPORT
Through our continued QMS support services your site will be able to maintain robust quality standards while spending, up to 70% less on a monthly basis compared to having a dedicated on-site resource to look after your site’s QMS.
SOP development and ongoing review
Development of tools and work instructions
Set-up and monitor key performance indicators
Aggregate, analyse and implement CAPAs to protocol/SOP deviations
Support your site on audit/inspection readiness
In depth GCP training & workshops
Click below to download Clinergy’s site QMS support program brochure.
