Developments in Bio Metrics Services
Identity seems to acquire greater importance when it is weak. This apparent paradox has been the debating point on identity in recent times.
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Developments in Biometrics Services
Identity seems to acquire greater importance when it is weak. This apparent paradox has been the debating point on identity in recent times. Conventionally, identity verification was always based on the approval of biographical and attributed features. Post the small and large scale societies, industrial societies; globalization presents the third era of personal identification. It is the human body that is at the center of all identity management strategy. The tension that is there between personal identity and human body is a crucial one in today’s health care sector. Keeping this in mind, most hospitals, health care organizations and clinical research organizations are working in order to come up with efficient biometrics system and biometrics security infrastructure.
What is Biometrics?
Broadly defined, biometrics is known as a set of methods deployed for observing and analyzing significant attributes of living people or populations in order to identify unique features or active properties. Innovative biometric identifiers must be:-
● ● ●
Universal i.e. biometric component exists in everyone Unique i.e. biometric element is distinctive for each person Permanent i.e. the property of biometric component will remain the same over a period of time in each individual
Biometric Services Offered by Indian CRO’s
Today Indian clinical research organizations i.e. CRO’s provide a complete range of data management services from Phase 1 Study to Phase IV studies as well as in bio-equivalence. The objective is to transform data into consistent and to the point trial outputs that complies with the regulatory rules.
Biometric team in CRO’s focuses on accelerating the regulatory submission process and reduces timelines through innovative thinking. The team is efficient in managing multi-centric studies, for global and domestic requirements in multiple therapeutic areas. The biometrics services portfolio in popular CRO’s includes the following components:-
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 present biometrical methods of identification comprise of fingerprints, retinal and iris scans ultrasound fingerprinting, facial feature recognition, hand geometry, ear shape, body odor, signature dynamics and many more. Research for future biometrics is on that will include DNA analysis, neural wave analysis, and skin luminescence.
Read Also On: Phase I Study, Clinical Laboratory
Identity seems to acquire greater importance when it is weak. This apparent paradox has been the debating point on identity in recent times. Conventionally, identity verification was always based on the approval of biographical and attributed features. Post the small and large scale societies, industrial societies; globalization presents the third era of personal identification. It is the human body that is at the center of all identity management strategy. The tension that is there between personal identity and human body is a crucial one in today’s health care sector. Keeping this in mind, most hospitals, health care organizations and clinical research organizations are working in order to come up with efficient biometrics system and biometrics security infrastructure.
What is Biometrics?
Broadly defined, biometrics is known as a set of methods deployed for observing and analyzing significant attributes of living people or populations in order to identify unique features or active properties. Innovative biometric identifiers must be:-
● ● ●
Universal i.e. biometric component exists in everyone Unique i.e. biometric element is distinctive for each person Permanent i.e. the property of biometric component will remain the same over a period of time in each individual
Biometric Services Offered by Indian CRO’s
Today Indian clinical research organizations i.e. CRO’s provide a complete range of data management services from Phase 1 Study to Phase IV studies as well as in bio-equivalence. The objective is to transform data into consistent and to the point trial outputs that complies with the regulatory rules.
Biometric team in CRO’s focuses on accelerating the regulatory submission process and reduces timelines through innovative thinking. The team is efficient in managing multi-centric studies, for global and domestic requirements in multiple therapeutic areas. The biometrics services portfolio in popular CRO’s includes the following components:-
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 present biometrical methods of identification comprise of fingerprints, retinal and iris scans ultrasound fingerprinting, facial feature recognition, hand geometry, ear shape, body odor, signature dynamics and many more. Research for future biometrics is on that will include DNA analysis, neural wave analysis, and skin luminescence.
Read Also On: Phase I Study, Clinical Laboratory
