Innovative Biometrics Service Portfolio By Cro’s

By Author: Alice Coope
Total Articles: 213
Comment this article

Biometrics authentication is an emerging field in which the concerned medical teams express concerns over identity concerns. Today laws and regulations concerning the same are being evaluated. Face identification biometrics has not reached the prevalent stage of fingerprinting, but with ongoing technological pushes and with the hazards of terrorism, researchers and biometric developers will stimulate this security technology for the twenty-first century.

Keeping in mind the modern day approach, biometric traits can be categorized in to two main categories. They are:-

* Physiological – that is associated with the body shape and therefore differs from people to people. Certain aspects of it are face recognition, fingerprints, hand geometry and iris recognition are certain specimens of this kind of Biometrics.

* Behavioral – that is associated to a person’s behavior. Certain examples of this case are keystroke dynamics, signature and voice. There are times when voice is also taken as a physiological biometric that differs from people to people.

Eminent clinical research organizations in India offer ...
... a comprehensive data management services in bio equivalence and phase I to IV clinical trials. The main aim is to convert raw information into accurate, consistent and reliable trial outputs in compliance with regulatory laws. These CRO’s have a dedicated Biometric team that focuses to speed up the regulatory submission process and lessen timeline through high end thinking and a commitment to quality. Biometrics services portfolio by the CRO’s is used by the device, biotechnology, pharmaceutical organizations. The portfolio includes the following:-

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

Clinical 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 in leading CRO’s in India is competent enough to assist at every clinical trail phases. The service portfolio here includes data management, statistical analysis & reporting, protocol writing, medical writing and Pharmacovigilance. The team is equipped with the innovative software systems such as Oracle Clinical, Clintrial, Rave, Inform, PheedIT, WinNonLin, SAS, SDMS & MedXview.

Read Also On: Medical Writing, Bioavailability