Developments in Biometric Services by CRO’s
The Biometrics technology has been there for a long time since the time of the standard finger print scanner. It not only helped to change the face of security and healthcare industry, but there have been much medical advancement done using innovative models of biometrics systems. One of the innovative developments has been the eye sensor controlled wheel chair. Simply put, this chair will automatically move in a certain direction with the assistance of an eye ball movement detection sensor. While there are many medical discoveries being made in this domain, there are many Indian medical institutions that have expanded their Biometrics service portfolio.
Indian CRO’s and their Biometrics Services
Popular Indian clinical research organizations i.e. CRO’s are equipped with their own Biometrics team that are well trained and assist in numerous clinical trials and other medical researches that take within the clinical laboratory. Their service portfolios are generally used by pharmaceutical, biotechnology, diagnostics, research and device.
Furthermore, the Indian CRO’s offer a complete range of data management services in Phase I -IV Clinical Trials and bio-equivalence. The main agenda here is to convert raw data into accurate, reliable and consistent clinical trial output in compliance with the regulatory policies. Leading CRO’s are often act as dedicated partner for the success of their client’s clinical development program for which their Biometrics team concentrates to speed up the regulatory submission process and reduce timelines by advanced thinking and commitment to quality.
They also have the ability to manage multi-centric studies as well as Phase 1 Study for domestic and global requirements in numerous therapeutic areas. The Biometrics service portfolio includes the following:-
Database Programming
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CRF Design (paper & electronic)
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CRF Annotation
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Database Programming
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Validation Checks
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Metadata Repository Management
Data Management
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Data Acquisition
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Data Reconciliation
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Discrepancy Management
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Medical Coding (MeDRA & WHODD)
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Database Lock
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Data Extraction for Reporting
Pharmacokinetic & Pharmacodynamic Studies
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Sampling Point Estimation
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Technical Document Review
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PK/PD Query Resolution
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PK/PD Subject Matter Expert
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Pharmacokinetic support across study engagement
PK/PD Reporting
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SDMS Data Extraction
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PK Data Analysis
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PK Summary Reporting
Biostatistics
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Randomization
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Sample size estimation
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Trial Design Inputs
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Statistical Analysis Plan
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Statistical Analysis
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Biostatistics Subject Matter Expert
Statistical Reporting
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TLF Programming
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CDISC Data Mapping (SDTM & ADaM)
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Clinical Data Repository
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Pooled Data Analysis & Reporting
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Safety (ADR) Reporting
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Patient Profiles & Data Cleaning Reporting
Biometrics technologies are taking great leaps and the new discoveries in this field will also be of help to people with complete paralysis. It is beneficial to medical candidates and testing sponsors. The testing sponsors are able to secure value of credentialing program by maintaining the integrity of the testing process. Furthermore, it deters proxy setting through a highly visible system.
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