Advanced Biometric Services Offered By Indian Cro’s

By Author: Alice Coope
Total Articles: 213
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Biometrics, also termed as biometric authentication consists of processes for recognizing human behavioral traits. The biometric traits can be divided into two principal categories. They are:

*Behavioral – This refers to an individual’s behavior, such as typing speed, voice quality, gait and many more. Certain researchers have coined a term“behaviometrics” to denote this category.

* Physiological – This is associated with the body shape. For instance, we can include here face recognition, palmprint, fingerprint, DNA, hand geometry iris recognition, and many more.

Eminent Clinical Research Organizations (CRO’s) in India have their own Biometrics team that is capable enough to help clients at multiple levels of clinical trials and studies. They assist clients with their technologies and know-how to come up with advanced study designs, analysis processes and provide help to the overall clinical development program. The expert teams are backed up by software application that comprises SAS and Winonline.

Leading ...
... CRO’s provide a comprehensive range of Data Management services in bioavailability and Phase 1 Studies. The aim is to convert raw data into reliable, accurate trial outputs in compliance to the regulatory guidelines. Furthermore, the clinical development programs in the CRO’s focus on ways to accelerate the regulatory submission process and lessen the timeline with the help of advanced thinking and service quality. The multiple sections of Biometrics services that the CRO’s provide include the following:

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

* 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 offered by the CRO’s have the capacity to manage Phase I to Phase IV clinical trials for domestic and global needs in multiple therapeutic area. Furthermore, the Biometric portfolio is utilized by numerous pharmaceutical, biotechnology, device, diagnostic and research organizations.

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