Our Sponsors Get
Quality Results Quickly

Recruitment Highlights:

• 3 full-time recruitment specialists 
• Patients pre-identified to ensure FPFV goal met
• Consistently meet/exceed # patients enrolled & enrollment timelines
• Average study retention rate of 98%
• Ethnically diverse database with 16,000+ subjects
• Wide range of recruitment avenues
  • Social Media/ Digital Advertising
  • Radio
  • Television 
  • Direct Mail 

Other Recruitment Services Include: 

• Community Outreach 
• On-site Seminars 
• Health Fairs 
• Volunteer Literature
• Networking within local healthcare community 

Investigator Oversight:

• Minimum of 2 on site at anytime
• Investigator participation in SQV, IM and SIV 
• Train the coordinator on the indication/study
• Review ICF and randomization criteria real time
• Functions as the coordinator as necessary
• Interactive relationship with Sponsor/Medical Monitor for each study

Regulatory Compliance:

• Accurate and complete document submission/reporting to Sponsor/IRB 
  • Deviations
  • Unanticipated events
  • SAE reporting 
  • Staff qualifications
  • Study delegation
  • Training
• ICF version control 
• Archive/retention of essential documents

Document Management/Archiving:

• TMF per study
  • Source document version control 
  • ICF document version control 
• Onsite locked storage
• Offsite long-term storage at Cor-O-Data
  • 24 hour document retrieval
• Shred-It for confidential document disposal 
• Computer backup in the cloud

Annual and Bi-Annual Trainings:

• Documented in employee files 
• SOPs 
• ICH/GCP
• ICF, AE Reporting 
• Continuous training on Protocol, ICF and Amendments  

QA/QC:

• FT and project-based QA/QC staff 
• 20% review per SOP; escalate as needed
• Real-time review of 1st subject enrolled
• Review of Sponsor DCFs
• Works collaboratively with CRAs

Lab & Pharmacy:

     Lab:

• Specimens packed/shipped/stored per lab manual/protocol 
• Dry ice delievered 2x per week 
• Samples are shipped via courier designated by protocol
• Central or local labs or both
• Locked and monitored refrigerators/freezers for storage
• All temperature logs are archived on site

     Pharmacy:

• Pharmacist on staff 
  • Study coordinator unless separate pharmacist required 
  • Unblinded staff include: Pharmacist or RN or MD as required
• Access and Accountability 
  • Limited access via pharmacy access register
  • Full accountablity records maintained
• Mixing
  • Laminar FlowHood for sterile mixing 

Outpatient Unit (Phase 2-3)

•   12,000 square feet
  • 3 exam rooms & 6 intake rooms
  • Lab/ draw area/ specimen collection 
  • Dedicated/separate workspace for monitors with copier and T1 wired and wireless access
  • 2 separate rooms for device studies
  • Large conference room
  • Offices for coordinators and MDs
  • Temperature controlled, keypad locked drug/device room with locked cabinets inside
  • Safe, dedicated parking lot
  • Alarm secured when not in use

Inpatient Unit (Phase 1, PK/PD, Extended Stay/Overnight):

• 2,300 square feet
  • 6 beds, 4 infusion chairs, 2 bathrooms (1 with shower)
  • ACLS certified nurses and physicians
  • One common ward area
  • Lounge/kitchen area
  • Long, open hallways
  • Safe, dedicated parking lot
  • Alarm secured when not in use
  • Fire alarm alerts directly to fire department for 1st response
  • Dedicated/separate workspace for monitors with copier and T1 wired and wireless internet 
  • Games, magazines, puzzles, TV for patient entertainment