Related Services
Medical Writing for SOPs, Procedures, Patient Narratives, Etc.
Development/ Review/ Revision of Standard Operating Procedures – Areas of writing services include, but not limited to clinical operations, project management, monitoring, data entry, data management, biostatistics, medical writing, quality assurance (QA), drug safety and pharmacovigilance.
Project Management
- Workflow Analysis (consultation)
- Design and implementation of clinical Project Workflow/Timelines (project management)
Clinical Monitoring Services
- Pre-study monitoring plan development
- Clinical site prequalification
- Clinical site initiation
- Interim site visits; ongoing data verification, test article accountability, and study file monitoring
- Study-site closeout visits
- In-house prospective and retrospective clinical study data collection and CRF completion
- Data integrity
Regulatory Compliance Services
- Development/ Review/ Revision of Standard Operating Procedures
- Development of FDA IND Safety Updates
- Development of NDA/ PLA/IND, BLA, IDE, PMA, and 510K Submissions/ Updates
- Review of labeling, marketing materials and packaging
