Clinical Trial Design & Statistics

Entropy Limited provides statistical data processing and analysis services. These include both safety and efficacy related statistical services for clinical trials, as well as providing designs for arrays of clinical trials that yield statistically sufficient information while conserving temporal and monetary resources.  Recruiting sites and patients and launching a clinical trial are amongst the most expensive activities in which a company can engage.  EL's "Efficient Paradigm" can be used to establish a proof source  for product registration utilizing a manageable number of patients and clinical sites.  The clinical trial array can be coupled to the economic valuation of a company's portfolio of potential products, insuring that clinical information is acquired at a rate which enhances the value of that portfolio while remaining consistent with financial milestones. 

Efficacy & Safety

Entropy Limited has worked for Celtrix Pharmaceuticals, Inc. and the Retinal Center at St. Joseph's Hospital analyzing safety and efficacy in clinical trials. EL drafted the statistical aspects of the clinical trial protocol, including sampling methodology and sample size determination, developed patient randomization procedures, and conducted statistical analysis of safety and efficacy in a clinical trial of a treatment for severe reduction in visual acuity due to full thickness macular holes.

Statistical Basis for Blood Testing

Entropy Limited has worked with NCGS Laboratories to establish and analyze a database, for Chiron Corporation and Gen-Probe, on a process for efficiently analyzing large numbers of blood samples. Data from over a million donors were used in the analysis. This new screening method is designed to test for Hepatitis and HIV.

Diagnostic Indicators

Entropy Limited teamed with NCGS & Associates to conduct statistical analyses for a number of clinical trials involving development of new diagnostic technologies for Ortho Diagnostic Systems, Inc.

Randomization and Sample Size Determination

EL and NCGS & Associates provided statistical services to GenenTech, Inc. and Lumenal Technologies. These services included sample size determination and patient randomization, and assured unbiased performance of the randomization procedure.

Blood Platelet Data Analysis

Entropy Limited conducted a statistical analysis of blood platelet viability and effectiveness in transfusion for HemaCare Corporation.

Arthritis Amelioration Trial Statistics

For CreAgri, Inc., Entropy Limited provided statistical analyses of arthritis changes in a product trial.

Breast Cancer Prognosis

For Exagen, Inc., Entropy Limited provided an evaluation of a draft protocol of a proposed diagnostic product, and a reconfiguration of the product claims to be consonant with preliminary data and clinical realities.

Mass-Spectrometric Identification of Proteomic Indicators of Diagnosis and Prognosis

For Predicant, Inc., EL provided protocol design and drafting services, acquired samples, reviewed data on instrument performance and provided advice on product reconfiguration.

 

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