Advanced Biometrics Service Portfolio by CRO’s

Biometrics recognitions are generally based on two principal premises about body traits, namely distinctiveness and permanence. The identification and applicability precision of a certain biometric train principally depends on to what extent these two premises hold relevance for the population at large. Face, fingerprints and iris are some of the well known physiological traits that are used in commercial biometric systems. Whilst fingerprint can capture more than 50 percent of the civilian market share.

On the other hand distinctiveness and permanence of several behavioral traits proposed in medical literature such as gait, signature and keystroke dynamics are weak. It has been observed that very less operational systems depending on these traits have been implemented so far. The selection of a certain biometric modality generally depends on the requirements and nature of the intended identification application. For instance, voice biometrics have been apt in authentication applications including mobile phones as a sensor for tracking voice is already embedded in the phone.

Indian CRO’s (Clinical Research Organizations) that conduct various clinical trials have their own dedicated Biometrics teams capable of helping clients at multiple levels of the trails and medical studies. They assist the clients with their advanced technologies and skill to come up with study designs, analysis processes, and interpretations and provide help with the overall clinical development program. The teams are further backed up by the new age software applications including Win non line and SAS.

Clinical research organizations (CRO) in India today offer a complete range of data management services in bioequivalence along with Phase I-IV clinical trials. The objective is to convert raw data into accurate, inconsistent and dependable trial output staying in compliance with regulatory services. The CRO’s have the ability to manage multi-centric studies for global and domestic needs in various therapeutic areas. The Biometric services provided by them are used by several biotechnology, device, and pharmaceutical and other medical research organization. The service portfolio includes 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
• Clinical 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 team in the CRO’s is expert to support their clients at every Clinical trial stage. The biometric services include statistical analysis, protocol writing and report writing and the team is well equipped by advanced software such as SAS and WIN NonLin.

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