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Biometrics Systems and Its Multiple Uses The term “Biometrics” means “Life measurement” and is generally associated with the use of unique physiological traits to recognize an individual. The application which majority people associate with biometrics is security. Today biometrics identification has acquired a wider significance as computer interface has become more natural. Known the individual with whom you are communicating is an essential aspect of human interaction.

A biometrics system can either be an “identification” or “verification” system, which is explained below:-

● Identification System – One to Many: In this case Biometrics can be used to decide a person’s identity even without his consent or knowledge. For instance, by scanning a crowd with a camera and making use of face recognition technology, one can find matches against a common database.

● Verification- One to One: - In this case Biometrics can be used to authenticate an individual’s identity. For instance, one can sanction physical access to safe data in a building by making use of finger scans or can sanction access to bank account at an ATM center by using retinal scan.

Eminent clinical research organizations in India offer a comprehensive range of data management services in bio equivalence and Phase I to IV a clinical trial that is carried on in their clinical laboratory. The main aim is to be able to transform raw data to precise, correct and consistent trial results that are in compliance with certain regulatory policies. These CRO’s have a dedicated Biometrics team that works to pace up the regulatory submission process and curb down timeline. 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

The Biometrics team within a CRO’s has the know-how to support in multiple clinical trial phases. Their service list includes statistical analysis, protocol writing and report writing. Furthermore, the team is well equipped with high-end software systems such as Win NonLin and SAS (SDMS & MED X view.

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Biometrics Systems and Its Multiple Uses