Biometric Service Portfolio in Leading CRO’s
Biometrics generally refers to the methods and technology of authentication of an individual making use of automatic verification of personal traits, for instance fingers, face, hands, eyes and voice with the use of geometry, prints and pattern identification and many more. The inhibitions concerning internet activities with security modifications by National Government have resulted in making biometrics occupy the center stage after several years of being noted as a potentially meaningful technology.
Esteemed clinical research organizations (CRO’s) possess their own Biometrics team that is experienced and help in all phases of clinical trials. The service portfolios are normally used by the pharmaceutical, biotechnology, diagnostics device and research institutes. These services include report writing, protocol writing as well as statistical writing equipped with innovative software for instance SAS (SDMS & MED X view) and Win NonLin.
In addition to that, the CRO’s provide a complete range of data management services during the Phase I to IV clinical trials and bioequivalence. The objective is to be able to transfer data into consistent and precise trial outputs in compliance with the regulatory policies. Biometric services offered by CRO’s in India focuses on speeding up the regulatory submission procedure and reduced timeline with the help of innovative thinking. It further has the capacity to manage multi-centric studies, for global and domestic requirements in numerous therapeutic areas. Biometric services include 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
Biometrics services are beneficial to both medical candidates and testing sponsors. From the testing sponsors’ point of view it safeguards the value of credential programs by maintaining the testing process integrity. At the same time it deters proxy setting using a highly visible system. Furthermore, it assists in safeguarding intellectual property from proxy testers and is adaptable to the ever changing international laws.
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