Advanced Biometrics Services By CRO’s

The biometric recognition technologies records unique features of an individual. It also makes use of this data to recognize whether a person is sanctioned to do what he is claiming to do. The features that are used to make the recognition comprises elements such as handprint, vascular patterns, voice patterns, fingerprint, typing speed, walking style and much more. This data is useful for the employers into order to control the access to strategic and confidential areas. It is also helpful in enhancing the attendance and for logical access control. When utilized in an organized manner this technology can be used to enhance the productivity and minimize occurrences associated with absenteeism.


Over the past few years there have been several biometrics discoveries. The biometric fingerprint reader is one such device that helps in recognizing and using the unique set of ridges on the underside of the fingerprint. Experts are of the opinion that, even two identical twins having the same DNA might have separate prints. This device effectively captures the fingerprint image with the fingerprint recognition algorithm estimating the difference between valleys and ridges making use of a high-end sensor. To make a print it is important for the individual to roll his fingers on the sensitive area of the reader. This biometric technology is useful in securing data, for instance the USB fingerprint reader can be plugged into the desktop in order to control access to the data.


Today Indian CRO’s (Clinical Research Organizations) engaged in clinical trials have their own dedicated Biometrics team working to speed up the regulatory service and submission process, lessen the timelines through innovative thinking and offering quality services. The service 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


Pharmacokinetic & Pharmacodynamic Studies


* Sampling Point Estimation

* Technical Document Review

* PK/PD Query Resolution

* PK/PD Subject Matter Expert

* Clinical 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


The modern day biometrics service portfolio offered by CRO’s also comprise of report writing, protocol writing and statistical analysis. Furthermore, they also use the updated software’s such as Win NonLin and SAS (SDMS & MED X view).


Read More About: regulatory services, Bioavailability