The C5Research Statistics team collaborates with investigators on the analysis of trial data and prepares the primary manuscript at the conclusion of the trial. In addition, several additional post-hoc manuscripts are usually developed in collaboration with the Trial Steering Committee, Publications Committee and investigators. Sponsor approval is obtained for all requests using the trial data. This exploration of the data and dissemination of the results through publication in top-tier, peer-reviewed medical journals are at the heart of C5Research’s mission as an ARO. To this end, and in response to medical journal dictates, C5Research must receive the trial data, preferably the trial analysis datasets, after data lock.
  • Protocol review of design and sample size
  • Review/input into statistical analysis plans
  • Review/input on CRF and Edit Checks
  • Independent validation of results
  • Support for manuscripts

Data Monitoring Committee (DMC) Services
The C5Research statistical team also offers services related to data monitoring committee (DMC) activities including critical review and input on charters and protocols, generation of safety tables, interim analysis tables and management of information flow between the DMC, study team members and sponsor. Our statisticians can also serve as voting members of the DMC to provide appropriate interpretation of results. All DMC activities are performed while maintaining complete confidentiality throughout the entire process.

DMC Services have been provided for the following recent trials:

• STAMPEDE (Ethicon, a Johnson & Johnson Company)

• AEGIS-1, AEGIS-2, Mod-RI (CSL-Behring)

• Phase II studies for Evacetrapib (Eli Lilly)