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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Regulatory Services Offered By Indian CRO’s.

India over the last decade has come up with various developments and advancements in medical trials and in project and data management. India has been successfully able to provide cost savings of 50 to 60 percent in clinical trials. With the research discovery acquiring approximately one-third of the R&D expenses of the western medical industry, outsourcing to lesser expense countries is a wise move. With the financial and regulatory pressure expanding in the US and European medical industry, it is estimated to propel the development in the Indian clinical trial market.

All this has compelled the clinical research organizations (CRO) in India to introduce advanced clinical laboratory services that assist in disease treatment and drug development. The medical doctors and technicians’ research experiment and conduct different medical studies and experiments and review human blood sample and assesses blood samples and evaluate the impact of drugs on the blood. This apart, the CRO’s also give importance to regulatory compliance services and appropriate quality assurance. There is a separate team for regulatory services and audit compliance that is in turn supported by a vast knowledge of the local regulatory procedures and helpful associations with various regulatory agencies ensuring perfection in the clinical trial approval process. Rigid healthcare budgets, patent expiries and stricter regulatory climate are some of the essential challenges that the medical industry witnesses today.

Renowned Indian CRO’s specializing in regulatory services has completed various audits from multiple global and Indian regulatory agencies. Simultaneously, there have been study submissions from multiple countries. The vast range of regulatory services offered includes the following:

• Formulating regulatory strategies
• Replying regulatory agency queries
• Renewing Import License
• Procuring drug import licenses
• Follow-up and submissions on the application
• Tracking applications and approvals
• Submission of Clinical Safety Report (CSR)
• Safety Reporting
• Procuring NOC for export of biological samples
• Compiling a clinical trial application

In addition to that, with regards to QA Indian CRO’ s have a complete quality assurance team to manage the same with a standard quality. The team focuses on quality that permeates through the processes within the domain of each single process. In addition to that, there are thorough implementations that are carried out by the Quality Assurance and Quality Control processes. QA practices span across Bioanalytical, Clinical, Statistics, Internal Audits and Reporting by the QA team for area specific SOP compliance. Simultaneously, there are other in-house capacities that CRO’s perform and includes of components such as Site Audits, Vendor Audits, Process/System Audits, and Document Audits that includes protocol, clinical study reports and important clinical trial documents.

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