We at COD research understand that clinical data to be a key asset of a clinical development programme of a client as it provides crucial and critical evidence of the drug safety and its potential economic value to the market.
We use an effective technology based enabled method to mange the client’s clinical data at the fastest possible pace. We use the most effective and reliable tools for data capture and ensue that the most authentic and reliable data is made available to our clients for early review and rapid decision making.
Our well designed and standardized approach to clinical data is protocol-driven with a site workflow-oriented and documented database and is populated via efficient data feed mechanisms. This helps our clients across the globe receive rapid responses to their regulatory and commercial questions. Our Clinical Data managers have with superior therapeutic and regulatory expertise and have the capabilities to execute functions and processes proactively which are essential to ensure quality data-driven productivity.
Key functions of the data management team at COD:
- On-shore and off-shore Clinical Data Management Services
- EDC and Paper Trial Set-Up & Management
- CRF/eCRF design and development
- CRF Annotation & Review
- Database Build & Design and validation specifications
- Edit checks Programming & Testing
- Data processing through double data entry
- Query Management
- Medical Coding
- Safety Data Management & Reconciliation
- Data Export/Transfer
- CDASH Compliant deliverables
- Real-time data viewing and reporting
Biostatistics Services
Our well experienced biostatistics team generates the clinical trial randomisation using all regulatory compliant software
- Statistical consulting for drug and device development: focus on protocol design, calculation of sample sizes, power calculations, and/or the production of a study randomization.
- Statistical analysis report writing for clinical study reports and/or manuscripts
- Integrated efficacy and safety summaries
- Data safety monitoring board support and participation
- Multifaceted statistical approaches including pooled analyses and meta-analyses
- Health economics and comparative effectiveness research
- Extensive statistical input for protocols and evaluations
- Comprehensive statistical analysis plans (SAPs) and table designs
We prepare tailored analysis programs which are tested and validated according to documented procedures. Our experts help in the detailed interpretation of study results and writing support for study reports and manuscripts. We offer a comprehensive efficacy and safety analysis for regulatory submissions. We also help you enhance your understanding the importance of Biostatistics in Study Design with a focus on:
- Adaptive designs in confirmatory trials
- Using external data in study planning
Innovative designs in early-stage trials