Advanced Clinical has strong guiding principles which lead our short- and long-term perspective on what platform we use internally to support clients. We do not strictly adhere to one platform, as we believe strongly in technological flexibility, integration and innovation to deliver the best results.
| Technology Guiding Principle |
Implication |
| Standards |
- Standard technologies and components
- Limited/No use of “black boxes”
|
| Reusability |
- All Application programs, whether developed internally or purchased, should provide modular and reusable functionality
- Select package anchor solution, then partner-related add-ons; if necessary, build programs
|
| IT Security |
- Appropriate information and systems integrity, confidentiality and security are ensured
- User categories have effective and appropriate access to systems and data
|
| Service Level Agreement |
- Remote access proactive and reactive system management capabilities exist in all systems; are fully utilized to achieve the desired service levels
- Core IT systems capable of providing a continuously available service
|
| Interoperability |
- Scalable, expandable and flexible to meet required projected growth and unpredicted growth
- Limited duplication across system platforms, unless there is a material value addition
|
| Integration |
- Technology can be integrated across EDC, CDMS, IVRS/IWRS and CTMS
|
| Functional Guiding Principle |
Implication |
| Regulation and Trends Compliance |
- Validate technology roadmap of vendors; extendable to new FDA regulations and other growing Life Sciences trends (e.g., Adaptive support)
- Enforce current / future state FDA audit requirements in system
|
| CTMS - Cross-Phase/Cross-Trial/Cross Function Integration |
- Integrate from pre-clinical, Phases I-III, FDA Review, Post-Market Analysis and Safety Monitoring and Reporting
- Integrate across Clinical Trials
- Integrate across Clinical Trial Operations to CMS to Marketing to Reporting
|
| Information Capture/Sharing |
- Provide safety/pharmacovigilance data across clinical, post-market surveillance and patient care to create comprehensive view into the drug’s safety profile
- Provide data necessary for FDA’s “Observable Measures of Outcomes Partnership”
- Provide data that help “prove value” based on NIH’s “Condition Agency for Drugs and Technologies in Health”
|
| Capability |
- Capability to work in the global environment
|
