• Utilized IRB Type: Central IRB

  • E.g., Advarra or WCG

  • Central IRBs meet every business day.

• Sites equipped with a full-time Regulatory Department

• Equipped with a Patient Services department that facilitates patient recruitment, retention, and marketing.

• Treated Age Groups: Adults (16 - 65 years of age)

• Recruitment:

  • Research database of over 10,000 potential candidates

  • Full-time Patient Services department

  • In-house created advertising and recruitment campaigns circulated locally

  • Social media and online digital marketing campaigns

• Retention:

  • Appointment reminders and confirmation via phone call and/or text message

  • Reimbursement for study participants

  • Transportation to visits provided as needed

  • Flexible scheduling to accommodate patient schedules and protocol windows

• IP Storage Capabilities:

  • Secured, controlled access room

  • Temperature log

  • Min/Max temperature monitoring

  • Temperature excursion alarm

  • Locked cabinet

  • Back-up power

Our sites and research staff have experience with the following:

• Electronic Data Capture (EDC) systems

• Electronic Clinical Outcome Assessments (eCOA)

• Electronic Patient-reported Outcomes (ePRO)

• Decentralized Clinical Trial (DCT) tools and services

  • Remote Source Document Verification (SDV)

  • Remote eCOA (electronic clinical outcome assessments)

  • Remote ePRO (electronic patient-reported outcomes)

  • Direct to Patient (DtP) IMP/study material shipment

  • Patient study digital application on BYO device

  • Patient Concierge (transport, reimbursement, appointment coordination)

  • Digital online recruitment

  • Digital patient engagement

  • Local lab or at home bio sampling

  • Wearables and sensors