Clinical
Safety systems are used by companies to manage and report their products'
Adverse Events. These systems are used pre-market during the clinical trials
phase and post-market after the product is available for sale. BioPharm
Systems has expertise with AERS™ from Oracle Corporation and Argus
Safety™ from Relsys Corporation. We
can help your company:
- Define of
functional requirements.
- Evaluate
available off-the-shelf systems based on the defined requirements.
- Install and
configure the software.
- Define business
processes.
- Develop required
SOPs and guidelines.
- Execute Operational
Qualification (OQ) validation using our validation suites.
- Develop Performance
Qualification (PQ) test cases based on your business processes.
- Train your
staff on the use of the system.
- Conduct of
a system pilot.
- Integrate
the clinical safety system with a dictionary maintenance system such as
TMS.
- Migrate data
from legacy systems.
- Develop SAE
reconciliation reports with Oracle Clinical or another clinical data management
systems.
Clinical Safety Brochure
