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Electronic Data Capture (EDC) Software

Octalsoft Electronic Data Capture software, supports early to late stage clinical development and post-approval phases through enhanced trial automation and workflows, complies with 21 CFR Part 11, provides standards-based integration and advanced query management capabilities.

Octalsoft Electronic Data Capture Software for Clinical Trials

Octalsoft EDC, a web-based and mobile enabled solution, provides a simple user interface to capture patient data in a compliant manner. With integrated online edit checks and query management features, you can capture clinical trial data faster and accurately. Octalsoft EDC maintains a complete audit trail ensuring compliance with 21 CFR Part 11 requirements and reducing risk across clinical development phases.

Octalsoft EDC’s powerful reporting capabilities help study teams visualize and analyze study data in real-time. By leveraging open standards, it allows for easy integration of clinical and non-clinical data from multiple sources. The flexible and scalable Octalsoft EDC modular solution finds patronage across the complete spectrum of clinical research community including, Pharma, Biopharma, Medical Device manufacturers, CROs, and Sites.

Why Octalsoft EDC?

  • Simple and secure data collection with online validation for assured accuracy
  • Study designer to set up complex studies
  • Maintains complete Audit trail
  • Multiplatform, multidevice support including smartphones and tablets
  • Faster submissions for regulatory approvals
  • Online integration of complex, multi-axial, hierarchical medical dictionary
  • Online collaboration to ensure prompt addressing of data discrepancies
  • Complies with regulatory requirements like 21 CFR Part 11 and HIPAA regulations
  • Adheres to independent industry standards like CDISC enabling harmonization of clinical data

Product Features

Data Collection

Simplify collection of clinical trial data at its source securely over the web

Data Validation

Online validation at the time of data entry ensures data is clean and accurate

Online Collaboration

Enables online collaboration over the data collection process ensuring issues with data discrepancies are addressed promptly

Study Designer

Robust Study Designer enables setting up complex studies in matter of weeks

Medical Dictionary

Online Integration of complex, multi-axial, hierarchical medical dictionary

Regulatory Compliance

Complies with regulatory requirements like 21 CFR Part 11 and HIPAA regulations

Audit Trail

Maintains complete audit trail of clinical trial data

Mobile

Supports tablets and mobile devices

Faster Submission

Facilitates faster submission of study results to regulatory for approval

Standardization

Adheres to independent industry standards like CDISC enabling harmonization of clinical data

Product Benefits

Better Trial results

Streamlined and standardized processes results in immediate efficiencies for clinical operations

Faster Patient Enrollment

Ability to assign targets to sites and track progress in real time results in identifying and recruiting high performing sites thus resulting in faster patient enrollment.

Improved Investigator relationships

Automate investigator and vendor payments based on pre-agreed milestones

Increased clinical research associate productivity

Automation in generating visit reports, tracking deviations, and centralized real time access to study data reduces administrative burden and increased capacity for the clinical research team

Lower Trial costs

Reduction in redundant system and processes shortens the entire clinical trial lifecycle

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