Scientific Developments in Biometrics In simple terms, biometrics technology is based on the identification of individuals by behavioral

or physical characteristics. Instances of such physical characteristics recognition includes face, iris,

fingerprints and hand geometry. Behavioral characteristics on the other hand can include signature,

voice, walking gait and other dynamics. Recently, there have been numerous contributions done in the

field of Biometrics by clinical institutes, eminent scientists and notable clinical research organizations

(CRO).

There have been various contributions from academic institutes and renowned international authorities

in this field as well. Medical professionals and researchers delve deep in scientific biometric treatments

and come up interesting discoveries relevant to the subject that comprises pattern matching algorithm,

data acquisition and other concerns that influence the system level, for instance standards, security,

databases and networks.

Today popular clinical research organizations in India provide a complete range of data management

services in bioequivalence and phase I to IV clinical trials that are carried on in their clinical laboratory.

The main objective is to be able to transform raw data to precise, correct and consistent trial results in

compliance with regulatory policies. These CRO’s have a dedicated Biometrics team working in order

to pace up the regulatory submission process and reduce timeline with the help of advanced thinking

and commitment to quality. Biometrics services offered by CRO’s are also utilized by the biotechnology,

device and pharmaceutical enterprises. The service portfolio includes:-

Database Programming

● CRF Design (paper & electronic)

● CRF Annotation

● Database Programming

● Validation Checks

● Metadata Repository Management

Data Management

● Data Acquisition

● Data Reconciliation

● Discrepancy Management

● Medical Coding (MeDRA & WHODD)

● Database Lock

● Data Extraction for Reporting

Pharmacokinetic & Pharmacodynamic Studies

● Sampling Point Estimation

● 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

Biostatistics

● Randomization

● Sample size estimation

● Trial Design Inputs

● Statistical Analysis Plan

● Statistical Analysis

● Biostatistics Subject Matter Expert

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 team working in Indian CRO’s has the expertise to assist in various clinical trial stages. Their

service list also comprises of statistical analysis, protocol writing and report writing. The team is well

equipped with advanced software systems for instance Win NonLin and SAS (SDMS & MED X view.

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