- a customer-centered data solution
For clinical studies that need electronic data capture systems, B1 EDC provides the following key benefits:
- Full featured, based on the CDISC ODM standard.
- Substantially lower cost compared with competing products (as low as 1/10).
- Rapid implementation. Testing can start in 24 hours.
- Unprecedented deployment flexibility.
- Exceptional ease of direct data access for consumption by third-party tools.
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The story of B1 EDC is straightforward - we have developed it into the type of
system that we wanted but could not obtain in our clinical research not long
ago. We want rapid implementation, low cost, clean and friendly user interface, sensible data structure for easy consumption
by a variety of tools. We believe other clinical researchers share the same desire.
Imagine you have a team developing a data solution specifically for your organization,
deployed on-premise or in the computing cloud, you have the full rights and full
control with no need to pay any fees. If you prefer the SaaS(Softwar as a Service)
model, you can also consume it as a service hosted by Biyee. That is B1 EDC, our
unique customer-centered data solution for clinical studies. Sound architecture
based on state-of-the-art and mature technologies, technical depth and superb efficiency
allow us to deliver asophisticated and individually built systems rapidly to help
you reduce the cost and increase the speed of your mission.
- Use Biyee's web-base and user friendly study
designer to translate a protocol or a part of it to a study design stored in
CDISC ODM format.
- Biyee builds the system rapidly (within 24 hours normally) based on the design
and deploys it on a Biyee's server for testing.
- Repeat the above two steps if changes or more CRF's are needed.
- Choose one of the following deployment destinations: A.Customer's own IT
structure; B. The computing cloud by one of a large selection of hosting
providers; C. Biyee's application server. The process takes less than 24 hours
Features and Benefits:
Regulatory compliance and standards support
FDA 21 CFR Part 11 compliant with complete audit trail.
- Support the CDISC
ODM standard. Biyee's B1 Study Designer
is entirely based on ODM. Study designs can be exported in ODM files to any other
systems supporting ODM.
- Web based application with no installation needed for end users. Support all major browsers.
- Available 24/7, accessible everywhere with strong security control.
- Biyee's B1 Study Designer has highly intuitive
user interface allowing users to design clinical studies by point & click.
- A collection of reusable data fields growing with the design process.
- Easy export and import of study design allowing copying then modifying a study quickly
- Instant test of CRF while designing.
- Highly predictable low cost.
- No hidden or maintenance fee. Customers own the delivered systems with full rights.
- No or minimal extra cost of customers' IT resources.
Analysis and Reporting
- Management reports.
- Reports customized according to specific and complex data reporting and analysis
- Clear and intuitive, hence analyst friendly structure of database allowing easy
and quick data retrieval for consumption by various third-party tools.
- Data exported in common formats ready for analysis with popular tools.
Scalability and Flexibility
- There is no upper limit for the size and complexity of a study.
- Cloud servers can be used to scale up or down the system and pay as you go.
- The system can reside on an intranet or in the computing cloud to best suit a customer's
specific situation. The hosting mode can be changed easily. The pay-as-you-go nature
of computing cloud minimizes wasteful spending on resources.
- Full suite of role-based user access control.
- SSL communication for encrypting data.
- Data access logging and report.