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Major accomplishments of SWOB:

 

 

    — Complete responsibility for SAS programming to integrate                                     20 clinical trial databases into an ISS for an NDA for a

        New dosage form (patch) for the treatment of ADHD

 

    — Primary statistical consultant to several startup

         Pharmaceutical companies.   Advised on Design and

        Analysis of studies.  Wrote SOPs.  Evaluated Technology.

        Wrote Data Management and Data Analysis plans.

        Statistical Liason to FDA.

 

    — Performed Quality Assurance review of Statistical Methods,

        Results, and SAS programming performed by CROs.

 

    — Managed SAS programming for 2 pivotal Phase III studies

         For an NDA for a new treatment for arthritis, and integrated

         5 study databases for the ISS and ISE.

 

    —  Extensive experience in Patient Reported Outcomes (PRO)

          endpoints,  particularly “Pain” related clinical trials (e.g.

         Migraine, heartburn, sore throat, dental pain, cancer pain, etc.)

  

                  

Recent SWOB Projects