Data Management & Biostatistics
At Confidence Pharmaceutical Research, we bring rigor, precision, and collaboration to every aspect of data management and statistical analysis. Our team operates at the highest standards of scientific research—ensuring data integrity, regulatory compliance, and clarity from study design to final reporting.
How We Do It?
- Integrated from the Start
- Engage early in study planning to help shape protocol design and statistical methodology
- Align data strategy with operational workflows and therapeutic goals
- Collaborate cross-functionally with clinical, regulatory, and medical monitoring teams to streamline execution
- Strategic Biostatistics
- Author protocol statistical sections and Statistical Analysis Plans (SAPs)
- Design and execute interim and final analyses tailored to study objectives
- Support regulatory interactions, including FDA and Competent Authority responses
- Prepare Clinical Study Reports (CSRs) with regulatory-grade outputs
- Reliable, Flexible Data Management
- Work within sponsor-preferred or recommended EDC platforms
- Build, test, and maintain validated eCRFs and data systems
- Develop and implement comprehensive Data Management Plans (DMPs)
- Manage ongoing data cleaning, query resolution, and final Database Lock
- Ensure all data is clean, traceable, and fully audit-ready
What Sets Us Apart?
- Early involvement that enhances protocol quality and statistical alignment
- End-to-end coverage—from protocol authorship to final submission
- Deep experience with major EDC platforms and system validation
- Tight integration with clinical operations and regulatory affairs
- Proven success with FDA- and EMA-compliant analyses and deliverables