Clinical Programming
Clinical Programming
Weltrix offers comprehensive clinical programming solutions tailored for Contract Research Organizations (CROs), empowering sponsors to efficiently plan, manage, and submit clinical trial data to regulatory authorities.
Our team combines deep scientific expertise, regulatory insight, and the latest data standards to ensure successful clinical studies.
What We Offer:
1. Database Design & Management
i. Creation and maintenance of Case Report Forms (CRFs/eCRFs) optimized for data accuracy and protocol compliance.
ii. Integration of electronic data capture (EDC) systems to streamline trial data collection and management.
2. Statistical & Clinical Programming
i. Programming support for the entire clinical data lifecycle, from data cleaning to statistical analysis.
ii. Generation of submission-ready datasets mapped to CDISC SDTM and ADaM standards, ensuring regulatory compliance.
iii. Development of Tables, Listings, and Figures (TLFs) that clearly demonstrate trial outcomes and safety results.
iv. programming with full documentation and validation processes.
3. Quality Control & Data Traceability
i. Dual programming and manual QC for data deliverables.
ii. Full documentation of data lineage and programming steps meeting the highest industry standards.
4. Regulatory Submission Packages
i. Preparation of electronic submission packages including annotated CRFs, define.xml files, reviewer’s guides, and comprehensive metadata.
ii. Mapping and conversion of raw data to standardized formats for agencies around the globe.
5. Interim Analysis & Reporting
i. Rapid generation of interim and final analysis datasets.
ii. Annual Clinical Trial Safety Updates and ongoing compliance checks.
6. Collaboration & Communication
i. Real-time, centralized data management and reporting.
ii. Seamless coordination among sponsors, investigators, sites, and data safety monitoring boards.
Our Approach
Below are the points:
Expert-Led Process: All programming is managed by experienced clinical programmers and project managers, ensuring accuracy and efficiency.
Flexible, Custom Solutions: Every client receives personalized attention, adapting processes and deliverables to unique study requirements.
Regulatory Mastery: Adherence to latest CDISC, ICH GCP, and country-specific regulations for both data handling and submissions.
Integrated Technology: Cutting-edge clinical trial management system for unified, secure, and scalable operations.
Why Trust Weltrix?
Proven track record with global pharmaceutical, biotechnology, and medical device clients. Focus on quality, integrity, flexibility, and responsiveness throughout the clinical trial lifecycle. Dedicated support from initial study build to database lock and regulatory submission.
Clinical Programming
Site selection, patient recruitment, investigator oversight.
Regulatory Affairs
Submission planning, with ICH-GCP, DCGI, and FDA norms.
Biostatistics
Includes EDC systems, analysis, reporting, and clinical study documentation.