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| Services : Clinical Data Management |
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At Accutest Research Laboratories, we recognize the importance of flexibility. As part of our Clinical Technology suite, we have the capability to perform studies using either CLINTRIAL® v4 or Oracle® Clinical v4, the two industry standard clinical data management systems. Both systems have been subjected to rigorous documented system validation and acceptance tests.
Stringent study-specific database testing and review procedures are performed, and we welcome client review and sign-off of our database testing reports. The following are documented and independently peer reviewed:
- Testing of database screens
- Testing of edit check
To ensure consistency, we use the same SOPs for database design, document testing, query issue and management, coding, and database lock, irrespective of database system. During global studies, our teams work to globally harmonized SOPs and access the same database via a secure link, eliminating database replication issues and decreasing time to database lock.
Our global Data Management team has significant experience using both systems and has designed over 120 databases in the past three years.
At Accutest Research Laboratories, we have experience in working with all the major Electronic Data Capture (EDC) software vendors, and our EDC team can provide advice on the suitability of EDC for each trial’s specific needs.
Data Management
Accutest Research Laboratories’ team of Data Management Specialists is strategically located in Mumbai, India and has Phase I-IV experience in a broad range of therapeutic areas using multiple technologies. We can support and deliver on all sizes of studies and programs.
We offer a flexible approach to our clients’ data needs and provide a wide selection of fully-validated systems, including:
- CLINTRIAL® and Oracle® Clinical
- MedDRA® coding
- Electronic Data Capture
- Rapid Data Acquisition models
- Client access to our standard data management status reports
Additionally, we offer the expertise to access our clients’ databases remotely, regardless of database design. As a result, our clients gain:
- Ownership of a database designed to their own specifications
- Visibility of database status and ability to monitor quality
- Improved access to data and faster database lock
We are dedicated to providing quality on time. Our fast track database close with by-patient locking and early reporting procedures are designed to avoid delays in database lock, while maintaining a quality deliverable. During global studies, our Data Management and Biostatistics teams work to globally harmonized SOPs and access the same database via a secure link, eliminating database replication issues and decreasing time to database lock.
Our Customer Portal provides clients with access to data on-line and on demand. Customized project status reporting facilitates information flow, resulting in informed decision making and superior trial management.
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