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High-End Biometrics Service Portfolio

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					                            High-End Biometrics Service Portfolio

Biometrics are also described as biometric authentication and includes processes for recognizing

humans related to one or more inherent behavioral traits. The traits on which the Biometrics

principle’s operates can be divided into two main divisions. They are:



      ●   Physiological - This is associated with the shape of the body, for instance face recognition,

          palm print, fingerprint, DNA, Iris recognition, hand geometry and many more.



      ●   Behavior – This is related to an individual’s behavior, such as the typing style, gait, voice

          quality, accent and many more. Certain researchers have also termed this category as

          behaviometrics.



Clinical Research Organizations (CRO) in India have a systematic and organized Biometrics team that

is expert to help clients at several stages of Clinical trials and researches. They support their clients

with the time tested technologies and expertise to set up analysis processes, interpretations, study

designs and provide support to the overall clinical development program. The expert groups are also

backed up by high-end software application that compresses SAS and Win Online.



Indian CRO’s also provide a comprehensive range of Data Management services in the

bio-equivalence and Phase I studies. Their objective is to convert raw data to precise and reliable

trial outputs complying with the regulatory rules. The clinical development programs in the CRO’s

focus on the speed of the regulatory submission procedures and lessen the timeline with the

assistance of advanced thinking and quality service. There are multiple categories of Biometrics, such

as:



Data Management
    ●   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



    ●   Randomization

    ●   Sample size estimation

    ●   Trial Design Inputs

    ●   Statistical Analysis Plan

    ●   Statistical Analysis

    ●   Biostatistics Subject Matter Expert



Pharmacokinetic & Pharmacodynamic Studies
    ●   Sampling Point Estimation

    ●   Technical Document Review

    ●   PK/PD Query Resolution

    ●   PK/PD Subject Matter Expert

    ●   Clinical Pharmacokinetic support across study engagement



PK/PD Reporting



    ●   SDMS Data Extraction

    ●   PK Data Analysis

    ●   PK Summary Reporting



Statistical Reporting



    ●   TLF Programming

    ●   CDISC Data Mapping (SDTM & ADaM)

    ●   Clinical Data Repository

    ●   Pooled Data Analysis & Reporting

    ●   Safety (ADR) Reporting

    ●   Patient Profiles & Data Cleaning Reporting



Biometrics services provided by well known Indian CRO’s also have the capacity to manage Phase I to

IV clinical trials for domestic and international needs in multiple therapeutic areas. This apart,

Biometric services are used by multiple pharmaceutical, biotechnology, diagnostics and research

organizations.



Read More        About: Biometrics    Companies,     Regulatory   Services, Bioavailability, Clinical
Pharmacokinetic

				
DOCUMENT INFO
Description: Indian CRO’s also provide a comprehensive range of Data Management services in the bio-equivalence and Phase I studies. Their objective is to convert raw data to precise and reliable trial outputs complying with the regulatory rules.