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Highlights
Having detailed knowledge of industry standards from organizations including WHO, ICH, CDISC, and the regulatory standards (e.g. 21 CFR Part 11, HIPAA, HL7, etc.) that drive the medical and life science professions, our team can assist in many areas, ranging across the eClinical business, technology, and compliance services spectrum.
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Professional Services
Experts in Clinical Research Applications
OmniComm Professional Services can provide product-independent consulting in all aspects of clinical research applications. Our experts have worked around the globe with pharmaceutical and life science companies, creating software and documentation products of the highest quality. Having detailed knowledge of industry standards from organizations including WHO, ICH, CDISC, and the regulatory standards (e.g. 21 CFR Part 11, HIPAA, HL7, etc.) that drive the medical and life science professions, our team can assist in many areas, ranging across the eClinical business, technology, and compliance services spectrum.
Understanding the dynamic and diverse needs of our clients, our service team can take on a variety of roles to accommodate customer’s specific requirements.
Customizable Services and Deliverables |
| Project Management |
- Project planning and management
- SDLC methodology creation
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| Business Specific Consulting |
- Business analysis and requirements gathering
- eClinical readiness assessment and workshop
- Data dictionary and global library design and development
- Industry standards adoption including CDASH, SDTM, and ODM.
- EDC metrics and measurement workshop
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| Technology |
- Infrastructure design and capacity planning
- Environment setup and installation
- Integration to enable a complete solution
- Custom software development and reporting
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System Interface Consulting |
- Custom imports and exports and web service implementation
- Data migration and transformation
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| Quality and Compliance |
- Process design and optimization, including SOP accelerators
- Regulatory consulting services, including validation accelerator
- FDA 21 CFR Part 11 compliance assessment
- Trial validation services for data capture systems
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Training |
- Custom training – webinar and/or workshop solutions
- Onsite clinical systems training
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Clinical Systems Consulting |
- Clinical data systems migration and adoption
- Trial eCRF design specification and study build
- Autoencoder systems integration
- Randomization setup and configuration
- Site support services
- Study archive services
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