Our Services

We can assist with specific services or with all services, including,

Communication with Sponsor

  • Scheduling and coordinating visits relating to site feasibility, initiation, monitoring and closeout
  • Corresponding with study sponsor regularly
  • Receiving and implementing updates
  • Obtaining and submitting study regulatory documents

Committee preparation and submission services

  • Creating and submitting iRIS applications to all necessary research committees on campus for approval
  • Submitting proper documentation to external ancillary committees for approval
  • Responding to any stipulations and requests for additional information
  • Meeting with study-pertinent hospital staff
  • Preparing and submitting initial reviews, continuing reviews, and study closures through iRIS
  • Preparing and submitting amendments, unanticipated events and all other documents through iRIS as needed

Sponsor Visits

  • Prepare for and facilitate the Site Feasibility Visit, Site Initiation Visit, Sponsor Monitoring Visits, Study Closure Visits
  • Prepare for and facilitate remote monitoring visits.
  • Ensure that permissions are obtained to monitor any areas related to study conduct as needed (i.e. UMC pharmacy, clinics, labs, etc.)

Study documentation

  • Create, update and maintain data collection forms, road maps, and additional documentation as needed
  • Organize, update and maintain all regulatory and subject documents, files and binders
  • Review, correct, and complete documentation on a regular basis.
  • Maintain records using ALCOA, GDP and GCP guidance

Electronic Data Collection Systems and IVRS/IWRS

  • Enter and update data collected on source documents on required systems as needed
  • Provide query resolutions and corrections as needed

PI Communications

  • Maintain communication with PI for subject recruitment, eligibility and procedures
  • Obtain PI approval for subject enrollment and subject study status
  • Meet with PI on a regular basis for signatures and updates

Samples and Storage

  • Ensure that the necessary storage is available for samples and/or IP
  • Prepare for and collect samples as necessary
  • Process, package and ship samples when required

Prepare, submit and maintain all requisition forms

  • Prepare and submit originals and copies of research service receipts to UMC and designees
  • Communicate with any departments as necessary in order to collect samples
  • Collaborate with the UMC pharmacy in order to receive, maintain, monitor, dispense and destroy IP as needed
  • Conduct IP receipt and accountability
  • Maintain shipment tracking receipts
  • Ship and receive IP from study participants for remote study visits
  • Collect subjects diaries
  • Monitor and log IP temperatures, lot and batch numbers, and expiration dates
  • Document destruction of expired IP as requested by the study sponsor
  • Obtain and store used packaging for IP