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Benefits of Express EDC

Benefits of Express

  • Scalable: The highly scalable, cost-efficient platform grows with the demands of your clinical study, from Phase I to Post-Marketing.
  • Rich Toolset: All utilities come built-in: data export; auto-encode with MedDRA and WHO Drug Dictionary; on-demand generation of blank workbooks; annotated CRFs.
  • All Inclusive, Web-Based: Everything comes in a standard web browser. No additional hardware or software is required.
  • Compliant: Our robust EDC platform meets all regulatory guidelines and conventions, including 21 CFR Part 11 and ICH-GCP.
  • eSource: Improve data quality and create efficiency with direct data entry into Express.
  • Industry Standards: Supports CDISC standards including CDASH, ODM, and SDTM.
  • Integration: Express integrates with other clinical data systems, such as laboratory, medical claims, call centers, IRT, and CTMS. Disparate data sources are integrated into one powerful data management environment allowing for efficient study analysis and management.
  • Ease to Learn, Easy to Use: Built by data managers for data managers, Express customers receive support from Bioclinica's experienced and dedicated service team and data management professionals.
  • Proactive Management Tools: Configurable notifications about adverse events, subject enrollment, new visits, and other activities help you to keep your studies on track.

Value-Added Capabilities in Express

Express is a best-in-class EDC that is continually advancing.

  • Flexibility: Ability to change study protocol without re-deploying or re-validating the EDC.
  • Full Edit Check Support: Superior logic for study build lays a foundation for quality clinical trial data. Unique "write-once"; cross–form dependency logic reduces the number of required checks and validation effort.
  • Data and Query Tools: Create personal or shared review displays with actionable drill-through.
  • Configurable Status Flags and Tagging: Define workflow for reviews around your processes and to maximize efficiency.
  • Cross-form Linking: Accelerate case review by connecting multiple CRFs for easy online review and extract the data you want.
  • Embedded Patient Questionnaires: Capture patient data directly — no separate tool required.
  • Embedded Auto-Coding Tools: Code adverse events and concomitant medications automatically or manually.
  • Dynamic Visit, Form, and Item Support: Reduce user effort by presenting only those CRFs and questions relevant to that subject.
  • Self-Serve Exports: Get on-demand study data in SAS and CDISC ODM formats.
  • Integration Options: Multiple batch import/export options and web services enable integration with third-party systems.
  • Integrated Trident Randomization: Integrated subject randomization, dosing, and kit assignment.
  • Cloud Transformation Gateway: Provides for seamless integration across Bioclinica's platform as well as third-party applications.
  • Auto Encoder: Eliminate drug classification errors by automatically assigning the correct drug classification according to your requirements.
  • Imaging: View the status of images on a single page using Bioclinica's integrated image functionality. Know whether an image was received, read, and where it is now.
  • One Subject: One Record: Move subjects from one study site to another while maintaining one consistent record. Great for "snowbirds" and others who have since moved or are away.

ADDITIONAL RESOURCES

Express EDC

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Full-Service Data Management & Enhanced Biometrics

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SAS Programming Services

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eHealth Patient Journey

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Pharmacyclics: First drug gets rolling, Express EDC utilized

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Bioclinica is organized into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging & Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Molecular Marker Laboratory. Our eHealth segment comprises eClinical Solutions, Randomization & Trial Supply Management, Safety & Regulatory Solutions, and Financial Lifecycle Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

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