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Periapproval Services
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Registries and Observational Studies
For over two decades, Covance Periapproval Services has conducted registry and observational programs for products, diseases, devices, and pregnancy outcomes in a variety of therapeutic areas. This depth of experience allows us to offer our clients unique solutions that leverage our years of experience, relevant expertise, in-depth understanding of both medical and scientific needs, and commitment to quality and service.
With our exclusive focus on the unique period of drug development just prior to and following drug approval, we specialize in working with actual practicing physicians, who require a significantly different approach than traditional, experienced clinical trial investigators. Because of this experience, we have developed best practices for designing registries, observational studies and epidemiological assessments; our programs are characterized by rapid start-ups, employing effective strategies for enrollment, retention and long-term follow-up, and providing creative uses of technology that support the needs of these types of studies.
Our approach is based on our expertise in conducting streamlined registries and observational programs and incorporates a number of key elements that lead to program success. Principal among these factors is limiting burden at sites through activities such as:
- Developing and implementing streamlined protocol and recruitment documentation
- Defining program processes that reflect actual clinical practice and treatment regimens
- Designing concise data collection instruments that focus on well-defined endpoints, with checkboxes or dropdown options rather than free text
- Providing rapid data acquisition, thus enabling rapid reporting of results
- Working with you to understand and meet your data needs and to provide valuable patient-based information.
Because sites that participate in registries and observational studies often have limited research experience, we employ a proactive, hands-on approach to help research-naive sites work through the program start-up process. We further accommodate sites by providing streamlined administration and support throughout each program's duration. Project and Data Managers are keenly aware of the importance of active site participation to long term program success.
Consistent with our goal to minimize site burden in completion of study assessments, all data are collected via electronic data capture (EDC). Covance uses the most current technology to capture of clinical, economic, quality-of-life, and satisfaction data, as well as patterns of use and safety events. We will work with you to identify the most efficient and cost-effective options available for your situation. Each option allows for rapid data capture, tracking, reviewing, and processing. This results in reduced data-cleaning cycle time and on-time reporting.
Covance project personnel are experienced with eCRF design and maximize the use of check boxes and multiple-choice questions while minimizing free text entries whenever possible. All of the EDC applications we use include front-end edit checks and mandatory fields to minimize the need for queries and data reconciliation. This allows us to manage data in real time with reports designed to address your specific needs.
One key to our success is the Focused-Response CRF. As data are entered on a patient, the application will determine which eCRFs and questions are necessary for completion. This helps alleviate site burden, acquire data effectively, reduce cleaning time, and reduce overall study costs. Our entire project team understands the importance of delivering high quality data to our clients.
At the center of our services is the Covance Observational and Registry (COR) Application, a Web-based, proprietary data collection tool designed specifically for registries and observational studies. COR offers a secure, user-friendly way to ensure you have an edge in today's competitive market. Advantages to the COR application includes:
- Maximal ease of use and setup via adaptive, menu-driven navigation
- Direct entry of patient data into the database
- Live edit checks for data accuracy
- "Real time" data management without paper-based limitations
- Industry-accepted System Development Life Cycle (SDLC) process
- Affordable hosting and maintenance by Covance
- No local software installation required
- Flexible, highly configurable modules:
- Document Repository & Message Board
- Fax/E-mail notification triggers and distribution lists
- Visit & eCRF scheduling
- Electronic signature
- Client configurable help screens
- Online query generation and tracking
- Case management tracking for site/patient contacts
In addition to our COR application, Covance has several custom-built, integrated applications that support a wide range of data collection and tracking. We have applications designed to assist with managing site information, investigator and patient grants, and safety information, as well as document tracking and imaging.
The capabilities and strengths Covance offers, coupled with our commitment to the success of all the programs we manage are the driving forces behind our strategy for delivering winning registries and observational programs. Our experience, organizational readiness and up-front planning position us well to meet your program needs. We appreciate the level of expertise our sponsors require and know that our experience and industry knowledge will exceed your expectations. |
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