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

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.

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