Quartesian
Quartesian
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Data Management
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Statistics
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  Statistics  
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In our efforts to provide the best statistical services, we try to stay integrated in the project from start to finish and work closely together with the sponsor to develop statistical plans that best support regulatory requirements while meeting sponsor's needs and standards in interpreting and presenting clinical data.

Our statistical services, which comply with regulatory requirements and ICH recommendations for statistical principals and reporting, include: writing statistical sections of preclinical and Phase I-IV protocols, sample size calculations and randomization schedules, statistical analysis plans (SAPs), specifications for case report tabulations, integrated summaries of safety and efficacy and statistical reports.

We have extensive experience in providing these services for NDA/sNDA/BLA/510K submissions as well as for product labeling, launch preparation and publication plans.

Quartesian combines appropriate validated software such as SAS®, S-Plus® and StatXact® with the expertise and experience so that the programs work for the sponsor in the most efficient way.

 
bullet Specific areas of our expertise include:

  • PK/PD analysis
  • Design of Experiments – Including high order crossover designs
  • Regulatory presentations for FDA, EMEA agencies and local European Agencies
 
     


     QUARTESIAN ADVANTAGE



     NEWS UPDATES
 
CLINIMINDS and QUARTESIAN form Strategic Alliance to launch Industry Oriented Clinical Data Management & SAS Training Programs .

Quartesian implementing open source EDC system - OpenClinica.

Quartesian India successfully completes training of the 4th batch of clinical SAS Programmers.

Quartesian India to provide experienced clinical  SAS Programmers to a Multinational CRO.