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Slide 1: Biometrics Services offered by the Indian CRO’s Medical science in India has progressed in leaps and bounds. The new diagnostics methods as well as new treatments are proving it so. Today, India has become the favorable destination for clinical trials as well medical tourism. Another, subject that is gaining prominence in the country is Biometrics, the science or the process of recognizing human cells based on certain inherent behavioral traits. Biometrics can be divided into two broad categories, namely Behavioral and Physiological. The Physiological biometrics deals with body shape and consist of palm print, iris recognition, fingerprint, hand geometry and others. Whilst on the other hand behavioral biometrics deals with the human behavior and takes into account things such as typing rhythm, gait, voice and so on. Eminent CRO’s in India have well-structured Biometrics team having the expertise in assisting clients and researches at different stages of Clinical trials and medical research. They provide their clients with innovative path breaking technologies and knowledge to set up study designs, analysis methods, and interpretations and offer other help in various Clinical Development programs. These teams make apt use of innovative software application that comprise of SAS, SPSS, PASS and WinNonline. Apart from these, CRO’s, also offers a comprehensive range of Data Management services in bioequivalence and Phase Trials. The main agenda is to convert the raw information to reliable, measurable and accurate trial results by adhering to regulatory guidelines. Clinical development programs also focus on speeding up the entire regulatory submission process and lessen the timeline with great service quality and innovative thinking. The various sections of Biometrics included in renowned CRO’s today are listed below- Data Management        Study Setup Data Entry & Data Acquisition Data Reconciliation Discrepancy Management Medical Coding (MeDRA & WHODD) Database Lock Data Extraction for Reporting Database Programming      CRF Design (paper & electronic) CRF Annotation Database Programming Validation Checks Metadata Repository Management Biostatistics       Trial Design Inputs Sample size Estimation Randomization Statistical Analysis Plan Blinded Data Review Reporting for Data Monitoring Committee
Slide 2:     Interim Analysis Statistical Analysis Statistical Inference to Medical Writers Biostatistics Subject Matter Expert Pharmacokinetic & Pharmacodynamic Studies       Planning Blood Sampling Schedule Technical inputs related to PK/PD and study design Technical Document Review PK/PD Query Resolution PK/PD Subject Matter Expert Pharmacokinetic support across study engagement PK/PD Reporting    SDMS Data Extraction PK Data Analysis PK Summary Reporting Statistical Reporting        Derived Data Specification TLF Programming & Reporting CDISC Data Mapping (SDTM & ADaM) Clinical Data Repository Meta-analysis Safety (ADR) Reporting Patient Profiles & Data Cleaning Reporting This apart, Indian CRO’s provide biometrics services that has the ability to handle Phase I to Phase IV Clinical Trials for domestic and global needs in multiple therapeutic areas. Click here for more on regulatory services & Clinical laboratory