Clinical Data Interchange Standards Consortium (CDISC)
We are a proud supportor of CDISC and their work to create and evangelize data standards within clinical research. To this end, TEMPO™ currently supports and complies with the following CDISC standards:
- Operational Data Model (ODM)
- Study Data Tabulation Model (SDTM)
- Study Design Model in XML (SDM-XML)
21 CFR Part 11
TEMPO™ is deployed as part of a validated system that complies with GCP predicate rule requirements, laws, and regulations for clinical trial conduct and FDA 21 CFR 11 for electronic record and signature use.
System Validation & Control
In the process of supporting various types of research initiatives, we must be robust enough to withstand regulatory and client scrutiny. All of our clients benefit from our operational integrity, even patient registries and other projects that may not produce data bound for FDA, NICE, EMEA submissions. This operational integrity results in reliable software, processes, and ultimately – data.
Standard Operating Procedures (SOPs)
Clinipace Worldwide SOPs govern how we manages our business and client data. Formal adoption of, and adherence to, a comprehensive set of SOPs based in part on ISO, COBIT, iEEE standards and FDA regulations ensures consistency and integrity in operations. These SOPs are available for review on site by clients and their designees.
Software Development Life Cycle (SDLC)
SDLC governs how we manage our software products and development processes. The SDLC fully documents the software and installs software version/release controls. All new features and bugs are tracked and triaged using industry standard tools.
- Software Design Specifications
- Software Requirements Specifications
- Software Functional Specifications
- Validation Plan
- Traceability Matrix
- Installation Qualification
- Operational Qualification
- User Acceptance Testing
Quality Control/Quality Assurance
We conduct thorough testing of all software products to ensure functionality is consistent with specifications. Formal test scripts are created according to documentation, and conducted by internal staff as well by the client, or their designee.
There are several levels of testing that occur, including:
- Internal testing of administrative tools on a version basis
- Internal testing of TEMPO™ platform on a version basis
- Documentation of testing
- Resulting in formal validation of the TEMPO™ platform
Once the platform is validated, each project goes through a similar process.
- Internal testing of client-specific configuration (client project)
- User acceptance testing of client-specific configuration (client project)
- Documentation of testing
- Resulting in release to production of client project