Clinical biostatistics services - Genproresearch

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Clinical biostatistics services

• GenPro offers expert consulting services on
  complex statistical issues encountered during
  study design or analysis. We provide guidance in
  incorporating and analysing the effectiveness of
  statistical methodologies in clinical trials with
  a great deal of expertise in adaptive designs and
  Bayesian analysis. Our clinical biostatistics
  services have experienced and critical thinking
  biostatisticians to assist clients. They are
  industry experts in several statistical areas
  including adaptive design, personalised medicine,
  Bayesian analysis and non-inferiority approaches
  with extensive experience in several indications.
  Genpro team has been working for more than 15
  years in NDA/ BLA/PMA submission and interacting
  with FDA/ EMEA and PMDA and actively collaborate
  with academic, industry and FDA working groups.
  We are well versed with CDISC data standards and
  electronic submission standards to deliver high
  quality, dependable analyses.

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Work Flow

• Study Design
• Adaptive Design
• Bayesian Design
• Enrichment Trials
• Interim Analysis
• Randomization Lists
• Interim Analysis
• Randomization Lists

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• Study Design
• Design of Statistical Experiments.
• To reach the objective an experiment should be
  designed appropriately.We the statisticians of
  Genpro helps to ensure that the experiments are
  designed in the best way to meet the objective of
  the study which will help to reduce the
  repetition of experiments.
• Adaptive Design
• Adaptive methodologies include Seamless Phase 2/3
  Designs,Group Sequential Designs, Adaptive Dose
  Response design etc.
• GenPro brings the expertise of designing and
  analysis of different types of adaptive methods
  to implement the most innovative clinical trials.
  Some of the adaptive methodologies include
  Seamless Phase 2/3 Designs,Group Sequential
  Designs , Blinded and Unblinded Sample Size
  Re-estimation,Adaptive Dose Response
  design,Futility Stopping Designs,Dose Finding
  Designs and Bayesian Adaptive Designs.

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• Statistical Section
• Study Objectives, Expected Outcomes, Sample Size
  and more.
• Genpro biostatisticians have a great deal of
  experience in writing the study objective, the
  assumptions regarding the expected outcomes , the
  sample size required and the specific statistical
  techniques that will be used to evaluate the
  results are included.
• Study Endpoints
• Identify the primary and secondary study
  endpoints.
• We engage in the planning stage of a clinical
  trial itself to identify endpoints, formulate
  testable hypothesis and to confirm the parameters
  of interest.

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• Bayesian Design
• Bayesian and Bayesian Adaptive Designs, used
  meta-analytic and modeling approaches.
• GenPro staff has extensive experience in the area
  of Bayesian Designs. They have been instrumental
  in designing several Bayesian and Bayesian
  Adaptive Designs, used meta-analytic and modeling
  approaches to reduce the sample size and led
  several discussions at FDA and EMA. They have
  been responsible for several PMA submissions
  using Bayesian approach.
• Enrichment Trials
• Enrichment strategies and study design options
  for decreasing heterogenity, prognostic
  enrichment and predictive enrichment. The
  decision to use an enrichment design is largely
  left to the sponsor of the investigation, but
  like the entire research and clinical
  communities, FDA is very interested in Targeting
  treatments to the people who can benefit from
  them (i.e., individualization). The ability of
  the study to demonstrate effectiveness, which can
  be enhanced by using an enriched population.
  Describing study findings properly in drug
  labeling.

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• Interim Analysis
• Interim assessments during the course of the
  study.
• Interim analysis is performed to assess quality
  of the data collected, or treatment effects
  during the course of the study. Genpro
  Statisticians has the expertise to understand
  the requirements of the study,development of
  interim analysis plan and designing relevant
  outputs.
• Randomization Lists
• Randomisation Center in charge of creating the
  randomisation lists and breaking the blind.
  Randomization is considered as an essential tool
  when testing for efficacy of treatment in a
  clinical trial. Randomized trials are gold
  standard of study designs since the randomized
  trials have the ability to avoid the bias. Genpro
  offers support in generating the randomization
  lists.

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