Our client had an expedited database lock for an Oncology study and lacked available Data Managers to support the project
Client:  Growing CRO
Location: Central NJ
Services Provided: Our client had aggressive deadlines set by the sponsor to close a phase ll Oncology study.  Orbis Data Solutions quickly provided a team of 4 Clinical Data Managers.  The team was comprised of a Lead Data Manager serving as the liaison with the sponsor and 3 Data Managers supporting the lead.  The database was locked on time and the study was successfully closed.

Outsourced project to a CRO needs oversight.
Client: Global Biotechnology Organization
Location: Midwest
Solutions Provided:  Orbis Data Solutions’ Biometric Practice was retained to perform Clinical Data Management services and oversee the deliverables of our clients CRO.  Over a 6 month period, Orbis Data was responsible for the approval of final CRF’s and CRF completion Guidelines, Approval of Data Management Plan and Edit Check Specifications, Approval of the Database and Edit Check Programming, and Database Lock.

Planned NDA submission with lack of statistical programmers experienced with CDISC / SDTM
Client: Midsize Pharmaceutical Company
Location:  Central NJ
Services Provided:  Our client required statistical programming support for an upcoming submission for a phase ll study.  Orbis Data provided an expert level Statistical Programmer to develop complex SAS programs to analyze and report clinical trial data in CDlSC SDTM format.