We offer Quality Control activities related to operational, financials, and study deliverables. A Sixth Sense? That’s what some clients have said. It’s actually the result of over 40 years’ experience.
We’ll check on the quality of the work performed by your Data Management CRO. We have standard review techniques enabling us to quickly review data and identify critical and inadequate data review processes. We know what works and we have learned what doesn’t work. Focusing on what’s most important when timelines are tight and understanding the key priorities of our customers help to make us all successful.
We have the knowledge and attention to detail required to review study documentation. These could be the review of protocol content, protocol to database design, data to TLFs, reports for publications, or the QC of your CSR.
We’ve seen where studies can go off track, and it’s anywhere! It might be at the at the start with an incomplete or inconsistent protocol or poorly designed database. Trouble can also occur during the maintenance phase of a study due to inaccurate implementation of data review techniques. At the end TLFs must properly reflect the data and support your endpoints and objectives. Finally, the Clinical Study Report content, flow and specifics must be precise and accurate.
We understand that often there is not enough time or staff to carefully review the detail of the proposals, contracts and invoices and even though we know invoices should be accurate and change orders valid, we see mistakes happen. We can help you find errors and validate invoices.