Study Three


We were contacted to help create an integrated safety summary for an imminent submission.  A large CRO had previously been hired to carry out the work, but there were inconsistencies and errors in the outputs, and the client felt that the only way to progress was to request PHASTAR to do the work, starting afresh.  The package included phase I, II and III studies - a total of 32 clinical trials in total.  There were many legacy dataset formats, but we worked on the project, creating CDISC compliant datasets, which were subsequently used to create the relevant outputs.

As the work was on the submission critical path, we worked closely with the medical writers in the company to ensure the trial was reported with no problems.  Feedback received from the client after the submission, was that there were no errors found and the FDA had no questions on the package.