Data Management – inference Inc.

Integrity in Data, Precision in Outcomes.

In today’s fast-paced clinical research environment, effective data management is crucial for the success of your trials.

Our clinical data management group provides end-to-end services to ensure all facets related to the clinical development objectives meet regulatory scrutiny. Our comprehensive clinical data management services are designed to enhance your clinical studies’ efficiency, accuracy, and reliability, ensuring that you achieve your research goals on time & within budget.

We offer complete support throughout the Data Management continuum – Startup, Conduct, and Closure. After all, the accuracy of the data is essential for the integrity of the statistical inference.

Study Start

Thorough review of the protocol before designing Case Report Forms (CRFs)
Evaluate all areas of efficiencies during the start-up phase to ensure we meet and beat timelines
Collaborate with statisticians, medical directors to ensure clarity on data used for analysis
In-house development of database with appropriate skip logic and edit checks

Creation of Data Management Plan (DMP)
Development of Data Transfer Specifications (DTS)
Preparation of Case Report Form Completion Guidelines (CCG)
Comprehensive outline of data handling throughout the study lifecycle
All relevant steps documented per Inference SOPs

Study Conduct

Diligent data cleaning via statistical tools to ensure accuracy
Regular delivery of study progress reports to the sponsor
Significant focus on formulating and addressing queries from study sites

Test runs with vendor data to ensure accuracy and consistency with respect to data collected in EDC
Ensure Reporting can be done frequently for safety reviews and ad-hoc needs

Study Closure

Meticulous reconciliation of SAE & external lab data using statistical programs
Efficient closure of queries and finalization of protocol deviation list
Pro-active steps and communication with all stakeholders

Preparation of documents for signature
Database lock and archival after all issues are addressed

Services Include

Customized Database Development

Create and implement scalable, tailored data collection specifications
Alignment with study-specific requirements for seamless execution
Proficiency in Medidata Rave™ and Medrio
Over 15 years of experience, with adaptability to use other EDC systems to meet
sponsor needs
Specialization in minimizing timelines and costs, map out efficiencies, reuse of
forms during study startup execution

Database Validation

Ensuring data completeness and regulatory compliance
Systematic checks throughout the data lifecycle to identify and resolve
discrepancies
Automation of data review listings for comprehensive and thorough validation
Close collaboration between data management and biostatistics teams
Creation of statistical data checks aligned with SDTM/CDISC standards

Data Reporting (DM Listings)

Customizable data reporting solutions
Collaboration between clinical data experts and programming to tailor reports to
your specific objectives
Real-time data metrics, Medical Monitoring, Coding
Automated data review listings including reconciliation listings

Compliance with industry standards

Adherence to GCP, ICH, and FDA regulations
Ongoing commitment to reduce the risk of non-compliance and project setbacks

Medical Coding

Expert medical coding with WHODrug and MedDRA
Ongoing dictionary management to accommodate updates necessary during the
clinical trial
Manual coding as needed

Additional Data Management Services

Functional Service Provider (FSP) – we offer flexible resource augmentation of
experienced and dedicated DM professionals to complement your resourcing
needs
Project and Program based resources using local and global resource models
Rescue studies – our team of professionals diligently works to develop and
execute a comprehensive transition plan with consideration of all stakeholders
ensuring data quality and integrity