The most important features for pre-approval clinical trial
In the EDC system for clinical trials, special functions are implemented.
Here are the most important functions for this type of project:
Flexible
configuration
of users’ roles: CRA, Investigator, project manager, data manager.
Several (multiple)
version support
Several versions of CRFs which are available for selected study sites.
No stop data collection
during the update
The update process does not interfere with the team’s work.
Complex eCRF
configuration
OnlineCRF supports multiple levels of eCRF with complex structure.
Unscheduled visit
support
We can implement an interface to work with repeated visits, unscheduled visits, unscheduled form, etc.
Lab data
validation
Set normal ranges for lab data and the EDC system will give warnings for incorrect data entry.
Medical Coding
MedDra dictionary is integrated to code medical terminology.
Secured access
Secure storage of data and multi-level backup for restoring data in emergencies.
Premium user support
Dedicated team will be responsible for user support. We provide quick feedback for any type of request.
OnlineCRF complies
with the industry standards
Why we differ
Fast startup
4 weeks from approved Protocol and paper CRF to the start of data collection
No heavy load for your team
We only need up to 8 hours of your time to produce a ready-to-go EDC system. All other preparation processes are undertaken by our team.
Unprecedented flexibility
We can configure any type of eCRF. We can also configure a custom function for your specific project's requirements.
Attention to detail
Before EDC system configuration, we study provided documentations and identify consistency.
Case studies:
Pre-approval clinical trials
The OnlineCRF team has implemented EDC system for different pre-approval clinical trials.
See all details in our case studies.
Prostate cancer drugs. III phase study
OnlineCRF has developed an electronic system for collecting data in 8 member countries. Data collection was carried out with the participation of 35 centers and 184 patients.
Read more
The herpes medicine. I phase study
OnlineCRF has created an EDC system for data collection and study control. An open randomized clinical trial of phase 1 in 2 parallel groups with the participation of 20 healthy volunteers.
Read moreResponsible for EDC system stability and availability
Roman Yanovish
Chief Technical
Officer
Roman has worked in the IT sphere for more than 15 years. He has worked for 6 years in electronic systems for clinical trials.
He organizes the work of the IT team, ensures the development of the platform, and implements new functions that are required by international practices and industry requirements. Thanks to competent team management, it provides stability and user convenience to the system.
