Clinical Trial Electronic Data Capture & Data Management
The OpenClinica specialists in Australia and New Zealand.
Cost effective EDC
OpenClinica is the world’s most widely adopted clinical trial software technologies powering research in over 100 countries. We primarily use the community edition of OpenClinica. This means no licensing fees, you pay only for the database build and validation. We provide a hosted solution to further reduce project costs.
QA and Regulatory Guidelines
Using Mobius’s verification and validation procedures, quality assurance is guaranteed. Mobius will work closely with your project team to develop a specification to ensure your EDC performs according to project requirements. Mobius will ensure your electronic records comply with GCP and 21 CFR Part 11.
A Flexible Approach
Many EDC tools are available for clinical trial data management. Mobius will ensure that your clinical trial EDC uses only the right tools for your project without wasting money on features you do not require. We can provide additional tools to help your project run more effectively such as randomisation and budgeting modules.
Mobius is actively involved in all stages of clinical trial data management. We have expert process knowledge that helps maintain the quality standards of Clinical Data Management (CDM) processes. Electronic Data Capture (EDC) is a clinical research cornerstone technology used to obtain greater speed, flexibility, quality, and usability around collecting and managing clinical research data. Mobius’s approach to implementing EDC in concert with a well-devised staff training strategy will help align mutual interests and produce reliable data output.
Our policies and procedures ensure that we comply with international regulatory requirements set by the TGA, FDA and the EMEA. All phases of the clinical data life-cycle are covered by a comprehensive set of SOPs.
All systems are validated and have been assessed for 21 CFR Part 11 compliance.
Why Choose Us?
- Immediate feedback
- More accessible Data
- Higher data quality
- Faster trials
- Regulatory authority accepted EDC
- Hand crafted solutions for each trial
- Cost effective design approach
- We offer end-to-end services
- CFR Part 11 compliance
- All solutions are verified & validated
- Provide training to your staff
- We are the clinical data experts
We design the EDC based upon the study protocol and case report forms (CRFs). From these documents we build a versatile EDC to meet any trial schedule with electronic forms that mirror the paper CRF source document.
Designing case report forms to capture all the protocol required data is more difficult that it seems. Mobius has many years of experience designing CRFs that are both logical and easy to use.
We provide high quality and affordable hosting in top tier data centres around the world. We will tailor a hosting solution to meet your needs no matter how difficult your project.
Save time and money by ensuring that data is correct at the time of entry. The EDC can check that all data points satisfy logical rules thus reducing manual query resolution required by the study monitor.
Verification & Validation
Prior to delivery Mobius conducts rigorous verification and validation of the EDC against the study protocol and CRFs to ensure the it functions according to specification.
Training and Support
We provide personalised training to ensure that researchers are adequately trained to operate the EDC and we provide a 24/7 ticketed support system.