Working as part of your team …
The operational model for PHACT is based on a very seasoned management team that is based in the U.S. and Europe providing training, functional management and project management of worldwide personnel so that project work is done to the highest FDA and ICH/GCP standards. Functional managers employed in these two locations oversee employees in the local countries, ensuring the highest level of quality, and provide therapeutic and technical expertise.
PHACT provides full clinical trial services from study design through to regulatory submission for marketing approval, enhanced by a superior level of customer service resulting in a rewarding working relationship for sponsors.
- Site Training – building clinical research capacity in developing countries
- Clinical Operations – including regulatory submissions, investigator selection, clinical monitoring, and clinical trial management.
- Global Project Management – Including local site budget analysis, risk assessment and mitigation, project feasibility, study tracking reports, vendor management, and study budget and timeline management.
- Biometrics – including Data Management, Electronic Data Capture (EDC), and Biostatistics.
- Medical Writing & Reviewing – including Marketing Approval Applications and New Drug Applications (NDA).
- Regulatory Support – including protocol planning and strategic development plans.
- Electronic Source Records