Capabilities
- Protocol Development and Writing
- Experienced pharmacologists and medical clinical trial writers
- Phase I-IV programs
- Project Management
- Investigator recruitment
- Investigator evaluation and qualification program
- Regulatory document preparation and tracking
- Protocol specific source document templates (diaries, detailed flow sheets etc.)
- eCRF and paper CRF creation
- Creation of newsletters for communication with sites
- Investigator Meeting
- presentations
- materials preparation and support
- Site Monitoring
- US coverage: regionally based
- Experienced in target therapeutic area
- Specialized, dedicated, certified
- Can meet emerging needs (unexpected, mid-project or during peak workloads)
- Medical Monitoring
- Adverse event tracking, review, reports
- Laboratory and clinical report tracking, review, reports
- Investigator and client conferencing and follow up
- Interface regularly with client and investigators regularly
- Patient Recruitment and Retention Strategies
- Flyer and mailer creation
- Conception, creation and full production of radio, television and print ad campaigns
- Web site creation
- Innovative retention tactics
- Audits
- Data validation
- Site
- IRB
- Data Management
- Oracle Clinical platform
- Database design and set-up
- Double blind data entry
- Data Validation
- Medical coding
- 21 CFR part 11 compliant
- Vendor Procurement and Management
- Laboratory
- Contracted vendors
- Support Services
| - presentations |
| - materials preparation and support |
Tel. 818.981.9100 | info@brightps.com
