Data Management

Optimized processes drive rapid data collection, query resolution, site closeout and database lock.

Our approach to data management uses a high-performance clinical trials management system, emphasizes rapid data collection, processing and analysis, and makes validated real-time data available continuously through secure project websites.

Smart Technology for Trial Management, Data Capture and Query Resolution

Data acquisition is only one part of the data-to-knowledge process. Providing useful, relevant information in a comprehensible form to different study team members is equally important. What happens to the data once it is in-house is equally important. Our Clinical Trials Management System is an internally developed, fully validated system that has been used and continuously refined for over 15 years. The system can acquire data from a variety of inputs, performs validation and manages queries. This allows our staff to enter the data, validate and release the queries rapidly, generally within 8 hours of receipt. Sites are able to respond to their queries via our web-based Data Query System (WebDQS); our monitors review outstanding queries for their sites on a daily basis to ensure rapid resolution and as an indicator of site performance.

Selecting the most appropriate method of data capture for a specific project

Site capabilities vary widely, especially when large, multicenter studies are involved, and circumstances differ according to type of study, including whether patient-recorded outcomes are includes. Recognizing this diversity, we offer a variety of data input methods, most of which obviate the need for keyboard data entry at the site:

• We rely primarily on the SmartPen, which is simple and intuitive and makes data available even before the patient has left the site. This same technology can be used on pad computers, though we do not recommend this in most instances;
• Optical Mark Read (OMR) forms are inexpensive, similarly simple to use and well suited for patient diaries and similar circumstances where time-stamping is not critical. These forms must be sent to Health Decisions for processing;
• Web-based EDC: We offer this option for the rare circumstances (few patients and sites) in which the printing and layout costs may not be justified;
• Other: With a flexible architecture, our system can accommodate any other collection method, including PDA, pad, IVRS, and other.

Efficient Management of High Volumes of Data

Highly efficient processes and automated routine components of validation enable us to process up to 10,000 CRFs in a single day. In addition we routinely use secure project web sites in our studies to provide real-time data trending and analysis to all project team members on a continuous basis. The real-time access allows us to put in place flexible study structures that are highly responsive to incoming data, rather than following rigid pre-determined plans.

Optimizing Site Closeout Minimizes Time to Database Lock

We routinely close large phase III studies within 2-3 weeks of the last patient visit. For smaller studies, the time from last patient visit to database lock can be a matter of days. This is achieved by continuous data management throughout the study, thus avoiding a backlog of data queries at the end, together with carefully planned site closeout visits (e.g. ensuring the investigator or coordinator is not planning to be away from the office at the critical time).

Fully Validated, Real-Time Data Enables Early Decision Making

Using our electronic trial systems we are able to provide contemporary data throughout the study. These data will be almost wholly validated with data queries resolved. Thus, there is a constantly updated, validated clinical trial database available for interrogation either through formal means such as planned interim analyses or informally via performance and quality tracking using the principles of statistical process control.