All studies run at MDS Pharma Services early phase clinics will use ClinQuick; however, this may be in conjunction with a client provided EDC systems or paper CRFs. If a client requires their own EDC system or paper CRF be used, MDS Pharma Services will run the study using ClinQuick, then enter the data into the Sponsor provided EDC system or transcribe on to the paper CRF. MDS has significant experience working with a variety of EDC vendors.
ClinQuick has been successfully used on more than 3000 studies, dosing nearly 100,000 subjects since its first implementation in 1993. To facilitate rapid data cleaning and client monitoring there is a data management presence at each of our clinical sites. All sites operate under the same data management SOPs, which allows for seamless operation of multi-site studies. In general, using ClinQuick® results in faster timelines, lower costs (33% less than traditional paper CRFs) and the accuracy of direct data acquisition.
Additionally MDS Pharma Services’ data management department provides traditional data management support for off-site studies. Namely:
MDS Pharma Services will work closely with your chosen clinical site to help provide the highest quality data, in the shortest possible timeframe.
CRFs (both from ClinQuick and paper based) and datasets may be customized to client specifications. MDS Pharma Services also offer Item 11 and Item 12 documentation for NDA’s, and full medical terminology coding of adverse events, concomitant medications, and medical and surgical histories, using the latest available coding dictionaries.
