B10analytics b e y o n d s i g n i f i c a n c e Your Perfect Analysis Partner

Who We Are B10analytics is a global provider of statistical and analytical solutions Our services are designed to assist clinical research programs and providing complete data driven solutions to pharmaceutical industry

Why B10analytics? High Quality Deliverables Reduced Cost Data Security Advanced Tools Experienced & Efficient Team ICH-GCP Standards Well Defined SOPs

We Focus…  Analytical solutions for  Clinical Research  drug development research  Medical and Hospital Research  Epidemiological data analysis  Genetic Analysis

We Support…  Early phase I Studies  Interim Analysis and proof of concept studies  Phase I-IV clinical trials  Bioequivalence and PK/PD studies  All therapeutic areas

Services for Drug Development Study Design Services for Drug Development Study Design  Study Design & Protocol Development  CRF & Questionnaire Design  Power & Sample Size Calculation  Advanced Randomization Techniqueses  Detailed Statistical Analysis Plan

Services for Drug Development Data Processing & Reporting Services for Drug Development Data Processing & Reporting  Data Management  SAS Programming  Analysis Datasets  Tables, Listings & Figures  Statistical Analysis & Clinical Study Report (CSR)

Services for Drug Development PK / PD Analysis Services for Drug Development PK / PD Analysis  in-vitro and in-vivo Bioequivalence Studies & Drug Interaction Trials  PK / PD Modeling for  Compartmental, non-Compartmental & Population Pharmacokinetic Modeling  Drug Administration such as Oral, Topical, Constant Infusion etc  Steady Sate Modeling & Analytics  Modeling for Plasma, Blood, Serum and Urine samples  Expertise in PK / PD Modeling using  Kinetica, WinNonlin TM & SAS®

Services for Drug Development CDISC Migration and FDA Submission Services for Drug Development CDISC Migration and FDA Submission  Annotation of blank CRF for FDA submission  Study Data Tabulation Model (SDTM)  Analysis Data Model (ADaM)  Preparation of export datasets

Contact Us… Contact Us… B10 Analytics Pvt Ltd 4 th Floor, Delta Point Near Technopark main gate N-H bypass road, Kazhakoottom Kerala ,India Ph: Mob:

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