The Evolving Biometrics Landscpae & Its Services

Over the past few decades there has been tremendous development taking place in the medical field

. In some cases it was new treatment methods that got discovered, whilst in other cases there were developments in an existing medical field. The same holds true for the biometrics industry. Fingerprints, iris scans and other biometrics are no longer only functions in the crime department. Rather biometric identification is now being widely used in transfer programs to bring about benefits to the poor. However the concern is much broader than this, i.e. Allowing citizens to set up an official identity is a critical aspect of the development process. Today identity is needed for so many reasons, banking and credit, voter registration, registering property, health care purposes and many more. A lack of id can act as a major hindrance and also makes a citizen more vulnerable to corrupt officials.

Keeping in mind all these aspects, eminent CRO"s in India that offers a complete range of data management services in the bio-equivalence and Phase I-IV clinical trials. The main objective of the CRO"s is to convert raw data into precise, reliable trial outcomes complying with the regulatory policies. These CRO"s have their own clinical development program and their biometrics team concentrate on speeding up the regulatory submission process and lessen the times by excellent levels of services.

These CRO"s has the capacity to manage various medical studies, for domestic and international needs in multiple therapeutic verticals. Furthermore their Biometrics service portfolio is used by many biotechnology, pharmaceutical, diagnostic, device and other medical research organizations. The services they offer include 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

* 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

In addition to that, the biometrics team in eminent CRO"s is capable of supporting clients at all phases of clinical trials. The team is also well equipped with new age software technology such as Win NonLin and SAS (SDMS & MED X view).

by: Gladeyas

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