Our Services

Please find below a list of services divided into categories:
  • Clinical Trials setup, conduct and reporting.
  • Data Monitoring Committee (DMC) / Data Safety Monitoring Board (DSMB).
  • Acting as YOUR Biometrics department in relation to third parties and internal.
  • Insourcing of Biometrics resources.
  • Statistical advice.
Clinical Trials setup, conduct and reporting:
  • Protocol input including e.g. Advice on trial design, sample size calculation etc.
  • Randomization e.g. Codelist, envelope handling or via IWRS .
  • eCRF setup delivering CDISC SDTM data (using eCOS DM system from Merge)
  • Data management in general
  • Statistical planning e.g. Statistical Analysis Plan, Table-Figure and Listing Shells.
  • Statistical reporting incl. holding Key Result Meeting
  • Integrated Clinical statistical Trial Reports and statistical report. MW via partner.
  • Statistical CTD support, CDISC Mapping in general
DMC/DSMB:
  • We have experience from more than 50 DMCs worldwide.
  • We have experience from ”just being DMC member” to ”organizing everything”.
  • We offer you a complete setup, including templates for ”everything (charter, minutes statements etc)”.
  • We handle the DMC secretariat: Organizing meetings, handle documents, reimbursements etc.
  • We handle the un-blinding and production of data packages .
  • We handle the meetings and the follow up to you.
  • We guarantee timelines.
  • We have backup for material and staff.
  • We make interim analyses, incl. futility analyses.