OnlineCRF

OnlineCRF is a clinical data management and electronic data capture (EDC) system designed for use in clinical trials. It is intended for sponsors, CROs, academic researchers, biotechnology companies, medical device companies, and pharmaceutical companies running studies across a range of phases and study types, including Phase II through Phase IV, post-market surveillance, registries, and retrospective studies.

The system is configured by a dedicated project team according to each individual study protocol, with all development processes based on standard operating procedures compliant with GCDMP. Deployment and configuration typically takes a few weeks. After configuration, OnlineCRF specialists provide training for sponsor representatives and offer ongoing support throughout the data collection period.

Core System Features

• Electronic data capture with a user-friendly interface designed to support efficient data entry by investigators
• Clinical trial database storage on multiple protected servers located around the world, allowing data restoration in the event of server damage
• System configuration and validation covered across all stages by the OnlineCRF team
• Support for randomization within study workflows
• Medical coding functionality
• Automated data import, including laboratory data
• Remote monitoring capabilities carried out by OnlineCRF personnel

Supported Study Types and Sponsor Categories

• Study phases: Phase II, Phase III, Phase IV, post-market surveillance (PMS), registries, and retrospective studies
• Sponsor types: academic research institutions, biotechnology companies, medical device companies, and pharmaceutical companies
• Product types covered include pharmaceutical products, medical devices or software, and dietary supplements

Service and Support Workflow

1. Initial consultation and free 30-minute data management consultation available to prospective clients
2. Quotation process based on study specifics including number of subjects, sites, visits, unique forms, and study duration
3. System configuration according to the study protocol by a dedicated project team
4. Validation of the configured system
5. Training provided to sponsor representatives following configuration
6. Ongoing support and contact maintained throughout the data collection period

Related Services

• Data management services available alongside the EDC platform
• Biostatistician services offered as a complementary service
• Free 30-day trial available for prospective users
• Live web demo sessions available, with account types including project manager, remote monitor, and investigator

OnlineCRF is developed and operated by OnlineCRF LLC, based in Wroclaw, Poland. The company holds relevant certificates and standard operating procedures (SOPs), and positions itself as covering all stages of system configuration and validation, which it notes is offered by few CROs in the market.