Clinical trials are required to collect and analyze data regarding the safety and efficacy of new drugs and devices. Accurate results are en:rely determined by the quality of the data collected. Without the right tools, data cleaning and query management can prove :me‐consuming and overwhelming, resul:ng in trial delays, which in turn leads to considerable loss of revenue. As an example, in 2009, Genentech’s Hercep:n generated $1.2 billion revenues before the end of the patent expira:on, i.e. $106 million per month. By using our latest tool N.E.A.T. (Normalized Editchecks Automated Tracking), sponsors can shorten :me for FDA submission by efficiently cleaning collected data as well as easily issuing and tracking queries.
Data Management
EDC has made rapid progress over paper‐based trials, significantly reducing query resolu:on costs. As a result, many Edit Checks are programmed in an EDC system to ensure high data quality through fast query resolu:on. However, it is not always feasible to program all Edit Checks in EDC before the start of the trial. Some Edit Checks are too complex or costly to program within an EDC system. Data managers or bio‐sta:s:cians realize the need for specific Edit Checks only once the data has been reviewed and analyzed. At this point, the valida:on for a new release of EDC with new Edit Checks would be cost prohibi:ve. Furthermore, combining EDC and SAS Edit Checks without integra:on can quickly become a tracking nightmare and oWen leads to human error. NEAT is addressing this pain‐point common to all EDC run trials. NEAT is an applica:on that streamlines query processing for any EDC system. It centralizes query processing from EDC and external systems while ensuring full clinical data integrity. N.E.A.T. provides cri:cal metrics related to query resolu:on and site performance. Data managers use N.E.A.T. communica:on facility to follow‐up with sites about outstanding queries efficiently. N.E.A.T. is a cuYng‐edge SAS®‐based solu:on for data cleaning automa:on that enhances automated edit checks. As an integrated tool, N.E.A.T. combines both EDC and query management in one unique system. It provides Data Managers with faster, more accurate data cleaning and ensures data consistency.
NORMALIZED EDITCHECKS AUTOMATED TRACKING (N.E.A.T.) N.E.A.T. leverages the powerful capabili:es of SAS® , the indisputable leader in business intelligence. The applica:on is compa:ble with any EDC system. A web version is available, easier to manage and configure than excel spreadsheets. Our experts are able to fully customize and implement the system to any specific study in around 4 weeks.
BENEFITS Bring together queries from mul:ple sources High standard of data quality and integrity Faster and simpler query management process Queries resolu:on Automated site performance metrics Cross placorm, support all EDC systems
N.E.A.T. was selected for presenta:on at WUSS annual conference amongst an « overwhelming number of submissions ». Learn more by reading our press release at www.clinovo.com/wuss
N.E.A.T. Data Management Solu:ons
PRODUCT FEATURES N.E.A.T. Core Configura)on: Data Managers and Edit Checks Ac)on List: Suggested queries to be processed by the data manager QC New Edit Checks: New Edit Checks tes)ng mechanism Unresolved Closed Queries Queries Master View: All SAS® & EDC queries with audit trail N.E.A.T. Dashboard N.E.A.T. Site Management
OUR TRACK RECORD N.E.A.T. has been in produc:on for 4 years and has successfully been used for 4 different studies involving over 20,000 pa:ents. Query resolu:on rate increased 6‐fold From 8 to 50 queries resolved/day 3,000 queries resolved in 2 months for FDA report Over 15,000 discrepancies resolved for 1 study Cleanup of over 2,000 pa:ents for FDA annual report
ABOUT US We are the leading technology Clinical Data Solu:on Provider delivering the fastest clinical trial development implementa:on in the industry. Leveraging a suite of internal clinical applica:ons as well as best‐of‐breed new technologies, we offer expert, tailor‐ made biometrics services to accelerate clinical trials and ensure successful FDA submission. Our comprehensive suite of services includes EDC, data management, biosta:s:cs, and CDISC. We are experts in open source clinical trial technologies such as OpenClinica, allowing us to deliver some of the industry’s most cost‐ effec:ve solu:ons.
Contact us today to accelerate your clinical trial! 800‐987‐6007 sales@clinovo.com www.clinovo.com