subject: Advanced Biometric Services Offered By Indian Cros [print this page] 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 individuals behavior, such as typing speed, voice quality, gait and many more. Certain researchers have coined a termbehaviometrics 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 (CROs) 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 CROs 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 CROs 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 CROs 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 CROs 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.
