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EDCplus Knowledge Transfer

Tap Into Bioclinica's Extensive Know-How

Click on image for larger versionBringing EDC in-house is a great way for research organizations to take greater control of their studies. There are many potential advantages to this approach. Bioclinica's Express EDCplus technology transfer positions you for success. Sponsors and CROs get a powerful, easy-to-use electronic data capture system supported by a comprehensive training program and unparalleled support. Additionally, Bioclinica provides:

  • A proven process for implementing EDC
  • Powerful yet easy-to-use technology
  • Comprehensive training with optional certification
  • A partner invested in your success

Fast-Track Study Build
One of the distinguishing features of Express EDCplus is Study Builder, a proven, efficient tool that accelerates study definition, deployment and change management. With its intuitive, web-based user interface, Express Study Builder is easy to learn and use. Anyone familiar with reading study protocols is ready to specify, build and validate CRFs, edit checks, study logic and even complex visit schedules with minimal training.

Embedded validation rules ensure that study designs adhere to industry and corporate standards before deployment. This reduces overall build times by eliminating tedious manual compliance checking.

Because Study Builder is embedded in Express, study deployment is at the push of button – making the transition from Development, to UAT, to Production seamless and error-free.

Easier Change Management
No matter how much planning goes in to a study, there will be changes. Express EDC is known for easy mid-study changes, and the EDCplus program is no different. The same tool that enables fast study build also enables rapid response to protocol adjustments without data management or migration concerns.

Bringing Express EDC In-House
Express EDCplus is more than a technology program, it is a knowledge transfer. Bioclinica provides everything necessary to institute an EDC program in your organization including Standard Operating Procedures (SOPs), Work Instructions, and Process Definition. Each customer is assigned a Bioclinica Program Manager to act as a guide throughout the 6-step process.

  • Envision – An assigned Bioclinica Program Manager initiates a kick-off meeting to establish implementation goals, objectives, and timelines.
  • Plan – Following a discovery session, the Program Manager prepares program recommendations and plans the launch.
  • Build – the Program Manager oversees the installation of Express EDCplus as per the established plan.
  • Stabilize – User Acceptance Testing (UAT) and any additional programs or add-on services.
  • Deploy – After assuring all deliverables are met, the system is running and ready for launch.
  • Governance – throughout the life of the program, your Bioclinica Program Manager will conduct meetings to ensure Express EDCplus is meeting your needs.

Training and Certification
Enterprise license clients have access to the Express EDCplus certification program to formally measure and promote the skills of their team members. Organizers can use certification to ensure consistency across studies and create the best situation for success.

The Express EDCplus program provides comprehensive training so users can perform all EDC tasks including:

  • Building forms
  • Creating edits
  • Deploying the system
  • Managing user accounts
  • Maintenance
  • Close Out

Support Always Available
Bringing EDC in-house doesn't mean the end of support. Our goal is to give our customers the same level of service they get with Bioclinica's traditional solutions. This includes access to our world-class, 24/7/365, help desk. Our live help options also include instant video chat to get help fast. Bioclinica's Help Desk can see exactly what the trouble is and get you back to work quickly via Lync (no Lync application required).

Resources

White Papers

Patient data drives clinical research, and the industry is transforming to improve the way data is obtained, which will ultimately allow patient-saving therapies and treatments to be brought to the market earlier to improve the lives of ourselves, our families and our friends.

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

Presenting at the DIA’s 21st Annual Workshop in Japan for Clinical Data Management, I had the opportunity to compare academic studies in the US vs those in Japan as well as the differences in data management practices between academic and industry studies.

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.

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

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