You’re a sponsor of clinical studies?
We support your quality management team in securing the quality of your study data
Quality management is not only one of our most important services that we offer – it’s also an aspect of utmost priority in our day-to-day operations. We live GCP!
You can take us at our word when you make use of our quality management support services. We assist you with clear gap analyses of your existing quality management (QM) systems, in the review or creation of standard operating procedures (SOPs) and other controlled documents, and in item-for-item quality assurance in the form of audits.
Gap analysis of existing quality management systems
You’d like to subject your SOPs to a critical review, or to establish a new QM system? With our in-depth experience in the area of clinical operations and our previous activities in a broad range of QM systems, we can swiftly identify any existing deficits, run a profound gap analysis, and give you advice on how to implement changes and/or amendments.
Creation or review of standard operating procedures
Based on the results of your own analyses or our gap analysis, we provide competent support in the review and/or/creation of SOPs, working instructions, templates, and other controlled documents. The style of our QM managers is pragmatic, and our language is precise, clear, and understandable.
Quality assurance by audits
Do you need an independent auditor to support you in the quality management of your clinical studies? On your behalf we conduct audits at study sites, qualify vendors, and examine your processes by means of internal system audits. We conduct the audits on the basis of our own standards or, if you wish, of your SOPs.
We keep a beady eye not only on the rules and regulations, but also on the people involved in the studies. Accordingly we support you in the most pragmatic way possible, doing our best not to disturb your work routine.
How can we support you in the quality management of your clinical studies?
Call Christian Hilgenstock directly on +49 (0) 1520 921 89 32 or write us an email.