Asiatic Clinical Research

Data Management

Asiatic Clinical Data Management offers full complement of Data Management services. Data Management Services are dedicated to the highest Quality, Excellence, and Client Satisfaction through Project Management, Communication, and Execution of studies.

Asiatic has comprehensive Data Management Plan which allows for rapid development of databases.

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, Asiatic focuses on full team involvement and communication with the sponsor so that the end result is a clean database delivered on time.

Asiatic has indigenously developed its own CTMS system (NEXT PHASE) - a dynamic application on .NET platform, where both paper and electronic data can be processed and managed. Electronic Data Capture and Remote Data Capture are integrated part of CTMS. The team is fully trained on this application and experienced in its usage.

Services provided by the team include:

Protocol Review
Case Report Form (CRF) Review
Case Report Form Design (in .NET Platform), Printing, Distribution, Collection, and Analysis
Data Validation Specifications
Database Design in SQL Server Application
Data Receipt, Logging, and Tracking
Data Entry
Query Management
Medical Coding Using MedDRA & WHODRUG
Data Quality Assurance
Data Transfer
SAE Reconciliation
Data Management Reporting
Data Review Meeting
Data Management Plan (DMP) Development
DMP Review Meeting
EDC Consulting

Biometrics:

The Biometrics Group in Asiatic encompasses the functions of Data Management and Statistical Programming. Implementing CDISC standards, Study Designing and management, Audit trials, Data Transfer are few of the highlighted features of this group.

Statistics and Programming:

As with Clinical Data Management Services, Asiatic Statistical and Programming team offers full complement of statistical services with experience in clinical trials ranging from Phase II through Phase IV. Our statisticians work with clients from protocol design and sample size calculation through CSR writing and review. Our statisticians and programmers have worked on protocols varied in size and complexity, across multiple therapeutic areas and study phases. Asiatic 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.

Services provided by the team include:

Protocol design.
Sample size estimation.
Statistical methods for Protocols.
Protocol and CRF Review.
Randomization Schedules by SPSS software.
Statistical analysis plan development for individual studies and ISS/ISEs.
Programming of statistical tables, listings and graphs.
CDISC dataset creation by processing data in to data conversion tool like "TABLE TRANS".
Interim analyses through SAS.
Independent programming verification through SQL Queries.
FDA and other regulatory body consulting.
Analyses for manuscript preparation.