Clinical Trial Electronic Data Capture
and Data Management

Cost Effective EDC

Cost Effective EDC

Mobius utilises clinical trial software technologies to ensure our clients receive value for money, whilst securing compliance and a quality service. We custom build and validate all of our EDCs in-house meaning you save substantially and don’t have multiple vendors to manage. Our 21 CFR Part 11 compliant EDC has flexible features such as DICOM image upload, date importation modules, eConsent, ePRO/eDiaries (accessible via smartphone, tablet, home PC), randomisaton modules, MedDRA coding and advanced data extraction.

QA and Regulatory Guidelines

QA and Regulatory Guidelines

Using Mobius’ 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.

QA and Regulatory Guidelines

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.

Our Approach

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.

  • Immediate feedback
  • More accessible data
  • Higher data quality
  • Faster trials
  • Regulatory authority accepted EDC
  • Hand crafted solutions for each trial
  • Cost effective design approach
  • End-to-end services
  • 21 CFR Part 11 compliance
  • All solutions are verified & validated
  • Provide training to your staff

Our Services

EDC Structure

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. No surprises and no fixed fees.

CRF Design

Designing case report forms to capture all the protocol required data is more difficult than it seems. Mobius has many years of experience designing CRFs that are both logical and easy to use.

Hosting

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.

Query Logic

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 that it functions according to specifications.

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.

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