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
- 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.