Biostatistics

BIOSTATISTICS

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 biostatisticians possess the experience and critical thinking 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.

Work Flow

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.

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.

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 TRIAL

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.

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 Statistician’s 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.

SAMPLE SIZE & POWER CALCULATION

Optimum sample size based on appropriate statistical tests for the hypotheses.

GenPro statisticians evaluate an optimum sample size based on appropriate statistical tests for the hypotheses which reflects the study objectives under a valid study design. The sample size thus determined should ensure that the test results are accurate and reliable with certain statistical assurance.

RANDOMIZATION ALGORITHMS

Web based Randomisation systems which incorporate multiple algorithms.

Genpro staff has the expertise in selection of the appropriate algorithm for the study from a complete spectrum of validated randomization methods.

Web based Randomization tools.

Frequentist or Bayesian plans.

SECTION OF STATISTICAL METHODS

Appropriate statistical methods based on the study hypothesis. Genpro statisticians help to figure out the most appropriate statistical method based on the main hypothesis or based on the primary and secondary efficacy endpoints.

SAFETY & EFFICACY ANALYSIS

Safety and Efficacy Analysis for Phase I-IV Clinical Trials.

Genpro statistician helps to figure out the statistical methodology adopted for the analysis, do the safety and efficacy analysis as per the SAP and reporting of safety and efficacy data for the study under consideration.

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