Data Management & Programming
Pratico Consulting is a trusted biometrics partner specializing in end-to-end data management and advanced programming for clinical trials. We support sponsors from study startup through database builds, standard alignment, and submissions with workflows engineered for quality, reproducibility, and speed.
Our data management practice is to be a liaison and ensure that datasets entering the biometrics pipeline are aligned with CDISC and NCI standards as much as possible and consumable to support efficient programming downstream from external vendor data transfers to other customers.
By combining deep clinical expertise with advanced programming expertise, Pratico reduces manual data management burdens and strengthens the integrity of every study we support.
Contact us to learn more about Pratico Consulting and how we continue to empower customers with solutions and services.
Services
Consultation
- Evaluating clients' projects to support team needs and achieve their goals.
Clinical Programming
- Expertise in clinical pharmacology in the early-phase I-II space, focusing on Oncology, Neuroscience, and Infectious Disease
- Simple to Complex Adaptive Design Studies
- Leadership in eCRF design and alignment with CDISC and NCI Controlled Terminology
- SDTM/ADAM specification development, TLF Mock Creation, Statistical Programming Analysis, and QC.
- Regulatory Submission Validation and Documentation Efforts
- Study Team Engagement
Programming Environment
- Cloud Platform Development Infrastructure
- Global Standard SAS Macro Library Planning, Development, for Data Checking and Automation
- Quality Assurance IQ/OQ/UAT Testing and Documentation
- SOP/WI Drafting, Review, and Approval
team engagement, and Sample managment
- eCRF Design Specification, Edit Check Review, and UAT Testing
- EDC Data Extraction Review and Query Resolution
- Sample Reconcilation
- Cross-Functional Team Engagement