Comprehensive Biostats Services Deliver Strategic, Timely & Customized Data Planning & Analysis

Therapeutic Depth:CNS

High quality and accurate data analysis is a critical component of all clinical trials. Typically, it is thought by sponsors to occur at the end of a study when the CRO starts reporting results to sponsors and investors. However, Biostats can and should also function as an aspect that has value at the outset of the study and at multiple points throughout the clinical development process.

Experience matters. SynteractHCR was founded as a Biostats provider and has more than two decades of experience in this area. This longstanding Biostats expertise is offered to our clients in three different options:

  • As part of a full service clinical research project
  • As a consulting service from our expert Ph.Ds. to develop strategies to improve your processes and oversight
  • As a standalone project for those clients who are handling other aspects of trials in-house

As your partner, our expert biostatisticians and consulting group determine the best methods for collecting, analyzing and presenting your data, all in compliance with regulatory guidelines. Our long-tenured team provides creative thinking and analysis optimized for your unique study designs.

SynteractHCR Biostatistics Experience is Comprehensive and Knowledgeable

You may choose any or all these processes as part of your full-service, consulting or standalone Biostatistics options:

  • Overall strategy, including: study design; randomization planning; establishment of priorities; sample size determination; selection of end points for EMA and FDA; determination of appropriate analysis methods; ADaM; statistical analysis
  • Regulatory strategy for Biostats: identification of documentation needed; guidance for FDA interaction, especially for end of Phase II and pre-NDA meetings; preparation and presentation of documents; briefing book; questions to anticipate
  • Adaptive design and group sequential strategies: advantages and disadvantages for your individual study
  • Innovative analyses and how to implement - e.g., Lag-time analysis
  • Integration of CDISC into entire study: review of legacy data; how to convert legacy studies to full CDISC-compliant databases
  • Timeline planning: requirements for each step prior to submission
  • Safety monitoring: reviewing safety data throughout the course of the study; establishment and coordination of data monitoring committees; participating on your DSM board or DMC
  • Consulting on ISS/ISE: identification of data needed from different studies; how to propose analyses from integrated designs

While providing biostatistics for clinical trials, SynteractHCR is able to provide “out of the box” thinking and analysis that will improve your clinical study design and output with responsiveness that is unmatched in the industry. Work with SynteractHCR to ensure the best statistical services for your trial.


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