Biometrics Services Offered by Cro’s
Over the past few decades, medical science and its multiple domains have taken a quantum leap with the help of the latest technologies. The same applies for biometrics, that can be defined as a technology that helps in identification of individuals based on their physical and behavioral traits. Examples of physical characteristics include iris, face, hand geometry and fingerprint recognition to name a few. Similarly, the behavioral traits involve elements such as voice, walking style, signature style and other similar individual features. Today eminent medical institutes and clinical research organizations (CRO) in India have contributed immensely in the domain of biometrics.
In India, esteemed CRO’s have been offering a comprehensive range of data management services in bioequivalence and Phase I to IV clinical trials. All these clinical trial procedures are conducted in bio clinical laboratories that the CRO’s individually own. The primary objective of this is to transform raw data into accurate and consistent trial outputs in compliance and regulatory policies.
Furthermore, CRO’s have their own Biometrics department with efficient medical professionals working to speed up the regulatory submission procedure and minimize the timeline making use of forward thinking and commitment to high standard and quality. Biometric services provided are frequently used by pharmaceutical, biotechnology and clinical organizations. The services 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
The biometrics team in CRO’s and other medical institutes are experienced in clinical trial phases. The team members delve deep in biometric treatments and experiments with innovative discoveries that help not only the medical but the defense and security and surveillance sectors as well.
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