Services

Project Administration:

Regulatory compliance
Scientific review
Budget development and negotiation
IRB/VA/UMC/CTU/TUHC submissions
Project activation
Annual review and approval
Adverse event reporting
Data safety monitoring
Project status change
Study closure

Project Management:

Study organization and planning
Estimation of patient numbers
Patient pre-screening and screening
Informed consent
Patient entry
Obtaining and mailing specimens
Randomization
Case report forms
Follow-up
Study-drug compliance
Audits and inspection

Training and Education:

Trainings at affiliate sites
Two day training for new hires
Training materials and amendments distribution