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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.

Resources

White Papers

Because a key step towards database lock is obtaining clean data for all patients, the ability to verify that data is clean early accelerates the ability to lock the clinical database. This ultimately shortens the overall study timeline while ensuring the quality of your data.

The promise of electronic data capture to improve the speed and quality of clinical trials is too great to be ignored. These eight "secrets to EDC success" will help you understand how to fulfill that promise and gain the full advantage of clinical EDC.

Blogs

Ever since the US FDA introduced Meaningful Use requirements calling for medical practices to begin using EHR systems, the race was on to find a way to pull the data from EHR systems into the EDC systems electronically.  Many options have been tried − most focused on accessing the data from the EHR in the native HL7 format.  While this solution works, it's not easy to do. One of the stumbling blocks is the inability of site personnel to access this type of data from their EHR.

At BioClinica's 2015 Global User Conference, I had the pleasure of leading an expert panel discussion on the future of data management. I would like to share some highlights from my perspective. Panel participants were Daun Bahr, senior director data management Orexigen; Queennette Santiago, head of data management Ultragenyx; Clara Plascencia, associate director of clinical data management Pharmacyclics; and Ann Seibel, clinical data manager BioClinica.

In my R&D role at Endo Pharmaceuticals, I have seen the lines between operations and clinical data functions becoming more and more blurred.

ADDITIONAL RESOURCES

Express EDC

Download Data Sheet

Full-Service Data Management & Enhanced Biometrics

Download Data Sheet

CLEAN PATIENT OPTICS

Download Overview Sheet

SAS Programming Services

Download Data Sheet

eHealth Patient Journey

Download Infographic

Accelerate Your Database Lock with Clean Patient Optics

Download White Paper

Pharmacyclics: First drug gets rolling, Express EDC utilized

Download Article

Leader in Clinical Trial
Management Solutions

Successful clinical trials require the ability to see key details and uncover hidden insights. Bioclinica utilizes science and technology to bring clarity to clinical trials, helping companies to develop new life-improving therapies more efficiently and safely.

Great advice from our Dir. Cardiovascular Imaging on how to achieve top quality imaging acquisitions & assessments… https://t.co/P57970FrOf
bioclinica (16 hours ago)
RT @CenterWatch: #CWWeekly: The increasing trend of adopting digital health and #mhealth apps for patient care. Read more, https://t.co/wo9…
bioclinica (17 hours ago)
RT @CenterWatch: Examining the difference between #patient engagement & patient recruitment. Read more in #CWPulse by @AshleyTointon, https…
bioclinica (17 hours ago)
RT @CenterWatch: How can #socialmedia play a role in health disparities and #clinicaltrial patient recruitment? Read more in #CWPulse by @A…
bioclinica (17 hours ago)
RT @RAPSorg: What New @FDAcdrhIndustry Guidance is Coming in FY 2018: Alternative 510(k) Pathway and More | #Regulatory Recon https://t.co/…
bioclinica (17 hours ago)
RT @RAPSorg: .@US_FDA Finalizes Guidance on Promotional Drug Labeling and Ads | #Regulatory Focus https://t.co/2rmtTWajlf #FDA #pharma
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