Advanced Clinical Trials Portfolio By Indian CRO’s

The field of biometrics studies and analysis can be described as a set of technologies and methods that are used to recognize humans, depending on a certain set of traits. Biometrics traits can be divided into two principal groups. First, the physiological traits that are associated with the body shape, where we can include face recognition, palmprint, fingerprint, iris recognition, DNA, hand geometry and many more. Second, the behavioral traits that are related to an individual’s behavior, such as typing speed and style, walking gait, voice quality and many more.


Clinical research organizations (CRO) in India today offer a complete range of data management services in bioequivalence along with Phase I-IV clinical trials. The objective is to convert raw data into accurate, inconsistent and dependable trial output staying in compliance with regulatory services. The CRO’s have the ability to manage multi-centric studies for global and domestic needs in various therapeutic areas. The Biometric services provided by them are used by several biotechnology, device, and pharmaceutical and other medical research organization.


Indian CRO’s (Clinical Research Organizations) that conduct various clinical trial have their own dedicated Biometrics teams capable of helping clients at multiple levels of the trails and medical studies. They assist the clients with their advanced technologies and skill to come up with study designs, analysis processes, and interpretations and provide help with the overall clinical development program. The teams are further backed up by the new age software applications including Win non line and SAS.


There are Indian CRO’s that provide a comprehensive range of Data Management services in Bio-equivalence and Phase 1 studies. The agenda is to convert raw data to reliable, precise and consistent trial results in compliance with the regulatory services and policies. Furthermore, the clinical development programs focus on accelerating the regulatory submission process and lessen the timeline with the help of excellent service quality and advanced thinking. The multiple sections of Biometrics in CRO’s include the following services:


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


This apart, Biometrics services in certain CRO’s also manage Phase I – IV clinical researches for several domestic and global requirements in several therapeutic areas. In addition to that, the service portfolio is utilized by several pharmaceutical, biotechnology, diagnostics, device and research organizations.


Read More About: Biometrics Companies, Bioavailability, Clinical Pharmacokinetic