Hide Notes 

Slide 1: CRO’s in India and Biometrics Portfolio Biometrics also known as biometric authentication comprise of methods for identifying humans based on one or more intrinsic behavioral characteristics. Biometric characteristics can be categorized into two main categories: Physiological – This is related to the body shape. However, for example we can include face recognition, fingerprint, palm print, DNA, iris recognition, hand geometry and the many others. Behavioral – This is associated with the behavior of an individual, for instance, gait, typing rhythm, voice and so on. Some researchers have coined the term behaviometrics for this category of biometrics.  CRO’s in India have a well-established Biometrics team that is competent enough to assist clients and researches at various stages of Clinical trials and medical research. They help clients with their proven technologies and expertise in analysis methods, selection of study designs, interpretations of results and offer assistance to the entire Clinical Development program. The expert teams are assisted by the innovative software application that includes SAS, SPSS, PASS and WinNonline. Eminent CRO’s offer a complete range of Data Management services in bioequivalence as well as Phase I Studies and beyond. Their mission is to transform raw information to accurate, reliable, measurable and consistent trial outputs in conformity with the regulatory requirements. The Clinical Development programs in the CRO’s concentrate to speed up the regulatory submission process and shorten the timeline with the help of innovative thinking and quality service. The various sections of Biometrics included in renowned CRO’s today are listed below- Data Management        Study Setup Data Entry & Data Acquisition Data Reconciliation Discrepancy Management Medical Coding (MeDRA & WHODD) Database Lock Data Extraction for Reporting Database Programming      CRF Design (paper & electronic) CRF Annotation Database Programming Validation Checks Metadata Repository Management Biostatistics      Trial Design Inputs Sample size Estimation Randomization Statistical Analysis Plan Blinded Data Review
Slide 2:      Reporting for Data Monitoring Committee Interim Analysis Statistical Analysis Statistical Inference to Medical Writers Biostatistics Subject Matter Expert Pharmacokinetic & Pharmacodynamic Studies       Planning Blood Sampling Schedule Technical inputs related to PK/PD and study design 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 Statistical Reporting        Derived Data Specification TLF Programming & Reporting CDISC Data Mapping (SDTM & ADaM) Clinical Data Repository Meta-analysis Safety (ADR) Reporting Patient Profiles & Data Cleaning Reporting Biometrics services in renowned CRO’s have the capability of handling Phase I to Phase IV Clinical Trials for global and domestic requirements in various therapeutic areas. However, the Biometrics portfolio is used by various biotechnology, pharmaceutical, diagnostic, device and research organizations. Click here for more on regulatory services