Data Experts Aligned with Global Therapeutic Experience
Pharsh Pharma’s data management team has industry experience across contract research organizations, biotech, medical device
and pharmaceutical companies. Therapeutically, the team aligns with the company’s experts in our core areas of renal, oncology, cardiology, respiratory, as well as experience in many other areas including medical devices studies.
Global Network Combines Data Management, Research and Distinguished Therapeutic Scientific Leadership
As a contract research organization (CRO) with offices in the US and sub-Saharan Africa that engages some of the regions’ most distinguished scientific expertise in a diverse range of therapeutic areas, we are able to leverage our scientific leadership to establish and maintain unique investigator networks across the region.
Data Management Services Include:
- Protocol review and design of CRF and attendant specifications
- Design, testing, validation, and maintenance of 21 CFR Part 11 electronic databases
- Regular data review/cleaning/query management
- External data reconciliation
- Web-based randomization and IP dispensing
- Integration with external randomization systems
- Database administration including user Management including site staff training
- Medical coding (MedDRA and WHO-DD)
- Electronic patient-reported outcomes (ePRO)
- Endpoint adjudication database design and set-up
- Application development and integration with EDC through API’s
- Good documentation practice
- Disaster recovery and back up services
- Data entry services
- Risk-based monitoring
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