Phase II-IV Clinical Trials:
Clinical Trial Management and Monitoring

Biometrics
The RCRS Biometrics Group encompasses the functions of Data Management, SAS Programming, and Statistics. Our Biometrics staff is located in India (Bangalore, Mumbai). The Group is currently implementing CDISC standards and is compliant with ICH guidelines.

Data Management:
RCRS Clinical Data Management offers the full complement of Data Management services with experience in clinical trials ranging from Phase I - Phase IV. Data Management Services are dedicated to the highest Quality, Excellence, and Client Satisfaction through Project Management, Communication, and Execution of studies.

RCRS has developed a comprehensive Data Management Plan template which allows for rapid development of databases with our partners and encompasses the following:

Database design and validation
User access rights
Data processing
Query processing and resolution
Coding and QC guidelines
Data transfers and data handling instructions
Global conventions.

During project execution RCRS focuses on full team involvement and communication so that the end result is a clean database delivered on time.

Our core Data Management system is Oracle Clinical. The team is fully trained on this application and experienced in its use. Services provided by the team include:

Protocol Review
Case Report Form (CRF) Review
Case Report Form Design, Printing, Distribution, Collection, and Analysis
Data Validation Specifications
Database Design
Data Receipt, Logging, and Tracking
Data Entry
Query Management
Medical Coding
Data Quality Assurance
Data Transfer
SAE Reconciliation
Data Management Reporting
Data Review Meeting
Data Management Plan (DMP) Development
DMP Review Meeting
EDC Consulting

Statistics and Programming:
As with Clinical Data Management Services, the RCRS Statistical and Programming teasm offers the full complement of statistical services with experience in clinical trials ranging from Phase I through Phase IV. Our statisticians work with clients from protocol design and sample size calculation through CSR writing and review. We have strong expertise in the full range of statistical methods including descriptive statistics, linear and nonlinear models, generalized linear models, categorical data analysis, time-to-event analysis, nonparametric methods, equivalence and non-inferiority methods and data imputation. Our statisticians and programmers have worked on protocols varied in size and complexity, across multiple therapeutic areas and study phases. RCRS can handle work as part of a full service project or take on discreet assignments for projects such as CDISC submission datasets and program validation.

The RCRS leadership team has a median of 15 years of experience in the industry, and has participated in numerous regulatory submissions. The core programming language used is SAS.
Services provided by the team include:

Protocol design
Sample size estimation
Statistical methods for Protocols
Protocol and CRF Review
Randomization Schedules
Statistical analysis plan development for individual studies and ISS/ISEs
Programming of statistical tables, listings and graphs
CDISC dataset creation
Interim analyses
Data Monitoring Committee support
Independent programming verification
Support for marketing
Exploratory analysis
FDA and other regulatory body consulting
Analyses for manuscript preparation