Customized training programs for clinical staff, protocol-specific SOPs, and technology platform deployment
Site Activation &
Training
Real-time monitoring, participant recruitment support, data quality oversight, and milestone tracking.
Final data reconciliation, regulatory submission support, and site archival documentation management.
Evaluation: We appropriately emphasize the minimal risk nature of biospecimen collections: Nurse Practitioners as PIs, custom biospecimen SOPs, sample integrity training
Right-Sizing: Fair market value budgets should look different for Biospecimen Studies, and our sites agree.
Information Management: Efficient processes complimented by tech – the essence of harmonization for the benefit of Biospecimen Studies.
Our Process
Study Initiation to Closeout
Feasability & Planning
Site selection based on patient demographics, therapeutic area expertise, and operational capacity. Comprehensive feasibility assessments with timeline and budget projections.
Regulatory & Compliance
IRB submission coordination, FWA registration verification, essential document management, and ongoing compliance monitoring.
