ClinPlus®
SAS-Based Data Management Software
ClinPlus® Data Management (CPDM) is a robust Data
Management software employed by over 50 biotechnology,
pharmaceutical and medical device companies. CPDM
software has been engineered to achieve highly efficient
clinical trial data processing with a minimal investment in
installation and setup. CPDM is a comprehensive SAS-based
system that is flexible enough to support a vast range of
scenarios, yet fully customizable to meet each organization’s
specific requirements.
ClinOps shares a unique partnership with the developers
of ClinPlus and works in close conjunction with them to
enhance the system’s capabilities, stress test and validate
each feature of ClinPlus. We can customize and manage
a system to meet the needs of every study, site and client.
Whether you select a traditional double-key data entry system or fax-scan
approach, ClinPlus can accommodate each method of data
capture.
The ClinPlus system of SAS-based datasets can be uploaded directly into a master database in compliance with 21 CFR Part 11.
ClinOps uses the system to develop a unified database structure with common data
fields, variable names, formatting rules, data conventions, and endpoint measures to allow for data mining
across studies.
Significant Benefits
- Quick to set up and easy to use
- Fully secure, robust software with complete audit trail
- Authorized users can logon via any standard web browser
- The web-based data capture system is fully integrated with paper and fax-based systems in a single database
- Data queries can be resolved on-site, in real time, directly in the master database
- Flexibility in choice of data transfer mode allows paper, EDC and fax transmission in one trial
Measurable Results:
- Reduced time to database lock
- Accelerate NDA submissions
- Eliminate FDA questions and minimize reviewers' cycle time
- 21 CFR Part 11 compliant
- Save time and money