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Biostatistics

Trident Biostatistics boast unequalled experience in the Australian Clinical Research Industry.  Between our Biostatisticians we can boast more than 35 years collective experience in support of the international Clinical Research Industry ranging from NGO’s, small and large biotech companies,  pharmaceutical companies, and CRO’s.

 Therapeutic area experience includes among others Respiratory, Oncology, Infectious diseases, and CNS.  Our staff fulfilled pivotal roles in the registration process of drugs they worked on, and have experience in setting up specialist task teams, serving on Drug Safety Monitoring Boards (DSMB’s), and providing data for such boards.

We offer a wide range of services to our customers, following a two tiered approach.  The first is our consultancy service, where we can provide support to our customers ranging from any one to all of the following services: 

Study design
Sample size calculations
Writing/reviewing statistical sections of protocols
Randomization schedules
SAS programming of tables, listings and figures
Interim analyses
Statistical analyses 

We also provide the following statistical services: 

General statistical consultancy and support
Answering questions from review boards and Ethics Committees
Serving on Data Safety Monitoring Boards
Interaction with Regulatory Authorities
Publications and manuscripts
Statistical Report writing
Contribution of Clinical Study Report text
Pharmacokinetics using Winnonlin® software

 

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