Online Query Management Systems Data Management Solu9ons
Clinical trials are conducted to collect and analyze data regarding the safety and eﬃcacy of new drugs and devices. Accurate results for any clinical trial are en9rely determined by the quality of the data collected. However, these data are o?en inconsistent. Data managers are responsible for ﬁnding and managing discrepancies using edit checks, that are then sent to the sites as queries to be resolved. One of the biggest challenges for data managers is to generate, track and manage these queries. Paper‐based studies are diﬃcult to manage without the right tool, while Electronic Data Capture can prove costly.
QUERY MANAGEMENT IN CLINICAL TRIALS Data managers are responsible for ﬁnding and managing discrepancies using edit checks, that are then sent to the sites as queries to be resolved. Tracking queries manually with a spreadsheet quickly leads to mistakes, while Microso? Excel VBA applica9ons come with drawbacks such as maintenance, lack of authen9ca9on and audit trail, single‐user.
OQMS: A FAST, COST‐EFFICIENT SAS®/IntrNet SOLUTION Clinovo, the technology leading Clinical Data Solu9ons Provider, has developed Online Query Management System (OQMS), a powerful stand‐alone query management system to track and monitor data discrepancies. Combines the data processing capability from SAS, the indisputable leader in business intelligence, with the versa9lity and sophis9ca9on of web user interfaces. Tracks and manages queries in a fast and cost‐eﬀec9ve manner using a dedicated applica9on and intui9ve user interface. Allows mul9ple users to simultaneously access the applica9on. Ensures security and compliancy using an audit trail capturing data updates. Enables programmers to easily include any addi9onal SAS modules.
PRODUCT FEATURES A fully customizable query process workﬂow A powerful tool able to generate custom reports leveraging SAS capability The possibility to write manual queries that are tracked and managed in the applica9on Access to pa9ent proﬁles directly from the interface, increasing 9me eﬃciency
To know more about OQMS features, download our white paper at www.clinovo.com
An audit trail recording any data update A simple sites fax review Note: SAS and all other SAS Ins1tute Inc. product or service names are registered trademarks or trademarks of SAS Ins1tute Inc. in the USA and other countries. ® indicates USA registra1on.
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BENEFITS OF OQMS OQMS combines all the beneﬁts of a web architecture with unsurpassed data manipula9on capability of SAS. SAS and SAS/IntrNet Fast and cost‐eﬀec9ve implementa9on Eﬃcient and accurate data explora9on, analysis and repor9ng Flexible and customizable at minimum costs Secure connec9on 21 CFR Part 11 Compliance Simultaneous access by many users A web architecture No so?ware installa9on Compa9ble across pla`orms and opera9ng systems Accessible from anywhere with a browser and internet connec9on Reduced maintenance with fewer requirements We introduced our OQMS solu9on in a presenta9on at Pharmasug 2010 conference, one of the most ahended SAS pharmaceu9cal conferences of the year. Learn more by reading our press release at www.clinovo.com/pharmasug
OUR CLIENTS Our clients range from small medical device industries to larger pharmaceu9cal and biotechnology industries that are conduc9ng or about to enter Phase I of clinical trials. Our clients include companies such as Genentech, Roche, Medtronic, Nektar Therapeu9cs, Intui9ve Surgical and Concentric Medical. For each and every one, Clinovo was able to develop unique solu9ons to answer speciﬁc needs and demands at lower costs, higher quality, and faster 9me to market. Sponsors choose us for our unmatched domain technology exper9se, ahen9on to details, problem solving skills, and quick execu9on.
Contact us today to accelerate your clinical trial! 800‐987‐6007 firstname.lastname@example.org www.clinovo.com