Syncopation Consulting

Syncopation ConsultingSyncopation ConsultingSyncopation Consulting

Syncopation Consulting

Syncopation ConsultingSyncopation ConsultingSyncopation Consulting
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    • Home
    • About
    • Our Experience
    • Services
    • Contact Us
  • Home
  • About
  • Our Experience
  • Services
  • Contact Us

Services we offer and specialize in

Biostatistics

  • Advising on clinical study designs and appropriate statistical analysis methods
  • Developing and reviewing clinical study protocols, statistical analysis plans, study reports, and sections of the NDA/BLA 
  • Writing and reviewing statistical sections of study reports, manuscripts, abstracts, and scientific presentations
  • Assisting in due diligence assessment in business development opportunities 
  • Preparing for and participating in meetings with regulatory agencies
  • Serving on data monitoring committees for clinical trials
  • Serving on mock panel of regulatory meetings 
  • Providing biometrics department management and infrastructure consultations 
  • Assisting in data management and statistics CRO vendor qualification
  • Giving short-series lectures in biostatistics 

Clinical Outcome Assessments

  •  Developing and advising on COA measurement strategies for clinical trials
  • Developing novel composite endpoints from item libraries that are tailored to individual trials 
  • Advising on electronic implementation of COA strategies in clinical trials
  • Advising on analysis methods of COA data in line with FDA Patient-Focused Drug Development Guidance Series
  • Developing and reviewing COA sections of clinical study protocols, statistical analysis plans, study reports, regulatory documents, and HTA/reimbursement submissions
  • Developing and reviewing patient/clinician interview guides

SAS/R Programming

  • Conducting statistical analyses and generate tables, listings, and figures for clinical study reports or manuscripts
  • Creating CDISC compliant datasets, especially for SDTM and ADaM models 
  • Performing independent validation of statistical analyses or dataset creations 
  • Provide statistical programming support for COA dossiers

Note

Because all our clients currently employ their own clinical data management department or vendors, we do not have infrastructure to perform data management services. For statistical analysis and SAS /R programming, we typically begin with databases provided by our clients’ data management department or vendors.


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