REDCap Cloud’s State-of-the-Art Unified Data Management Platform

How REDCap Cloud’s Unified Data Management Platform Works For You

The health care industry has spent more than a decade replacing manual processes with automation to advance patient care. For example, the introduction of EDC for clinical trials, EHR systems for medical records, clinical registries for foundations, medical claims payment systems for Insurance companies and mobile applications for patients. On their own, these applications have improved processes however they have left data siloed. Ultimately, the key to improving healthcare is having the right data to make the right decisions.

The challenge is making all these applications talk to each other and let the data flow among all healthcare stakeholders as a unified and collaborative system all while operating in a compliant and secure way. The drive to connect processes and systems—both internally and externally—in a standards based way has created the need for a completely different approach. One that combines the depth of application functionality with the openness of industry standards. One that brings together isolated applications and data into a single system, allowing you to leverage business processes across patient and partner communities and create software to meet your ever-changing needs.

We call this approach Unified Data Management. It’s going to change the way you build, manage and deploy solutions to capture, manage data and make decisions.

REDCap Cloud Unified Data Management platform empowers individuals and organizations to collect, integrate, analyze and share health data in a standards-based way to make the right decisions at the right time. The overall solution consists of a combination of applications on a state-of-the-art cloud-based platform supporting the entire data management process from beginning to end:

APPLICATIONS

REDCap Cloud EDC
REDCap Cloud MyHealth Patient Portal and Mobile Applications
REDCap Cloud EHR Integration Hub
REDCap Cloud Analytics & Big Data Warehousing

REDCAP CLOUD PLATFORM

Workflow Management

Global Form Library

Integration Hub

Master Data Management

Version Control Management

eLearning

Data Warehouse

Global Hosting

Security and Compliance

The REDCap Cloud Unified Data Management Platform empowers CROs, sponsors, investigators, and research teams to collaborate around the world to transform patient care in a faster, better and more cost-effective manner.


UNIFIED DESIGNER

 REDCap Cloud’s Unified Study Designer is a point-and-click user interface that takes the process of developing studies away from programmers and into the hands of the study designers. Users can build EDC, eCOA and eSource studies from a single interface and form library.


GLOBAL FORM LIBRARY

REDCap Cloud’s Global CRF Library allows for the secure and controlled establishment of standard form libraries that can be leveraged across enterprise-wide deployments. Study designers can easily select and reuse components ranging from edit checks to entire forms and visit structures.


MASTER DATA MANAGEMENT

Our master data management module enables you to centrally manage data for Sites, CRFs, Roles and Permissions, Response Sets, Look-up Codes, and Reporting and Analytics. This enables the customer to configure the application to meet their needs across a portfolio of clinical research projects.


INTEGRATION HUB

Plug in new and innovative technologies. As a native cloud-based platform, REDCap Cloud offers APIs for nearly every feature and function on the platform and associated application modules. The following provides an overview of some of the current APIs by category:

Study APIs

  • Export Studies
  • Import Studies
  • Get Study Metadata

Site Management

  • Get Site List
  • Create Site
  • Update Site

CRF Versions

  • Create new version of CRF
  • Partially Update CRF Version
  • Get CRF Version Details

Patients

  • Get Patient List for Study
  • Add new patient into study
  • Update patient
  • Get list of patient CRFs for study

Export/Import

  •  Import or Export Events, Studies, Metadata, Event Mapping, Study Data

CRF Items

  • Get items list for CRF form
  • Create new item in CRF form
  • Update CRF item

Study CRFs

  • Get CRF list for Study
  • Get CRF details
  • Create CRF

Study Sites

  • Get Site List for Study
  • Add Study Site
  • Update Study Site

Study Events

  • Get Events list for Study
  • Add Event to the Study
  • Update Study Event

Surveys

  • Get Surveys List for Study
  • Create new Survey
  • Partially update Survey

USER ADMINISTRATION

Role-based access control security is completely integrated within the REDCap Cloud platform. All access levels and permissions to the data, whether via the user interface or API, are fully configurable down to the field level, via a Web UI front end. Flexible user privileges allow a single user to be defined across multiple sites, with the ability to vary roles between studies. These role permissions fully permeate all integrated reporting tools, data access, data input, etc., without the need for separate configuration.


eLEARNING

REDCap Cloud includes role-based e-learning curriculums and certifications built into the application.  These modules can be customized by the client with assessment standards set by the client administrator. So, e-learning is tailored for every role in your trial and the modules can be completed at each user’s own pace and convenience.

Sites

Customized, on-demand and self-paced training courses for ease of use.

Instant, downloadable training certificate.

Sponsors & CRO’s

Role based curriculum right for your users training needs; ie, Data Management, Monitoring, Project Management.

Administrative access putting you in control of what training is delivered and completed.

Patients and Care Providers

Interactive training—including video modules that reside on the same device as the eConsent and eCOA assessment.

Training can be deployed in an offline environment.
Increases patient engagement and understanding

SOFTWARE VERSION MANAGEMENT

REDCap Cloud has developed proprietary Software Version Management (SVM) technology empowering you to simultaneously run an unlimited number of versions of REDCap Cloud Applications. For example, a client can upgrade each study in their tenant individually and at any time with full Installation Qualification (IQ) support.


GLOBAL HOSTING

The REDCap Cloud platform has been Designed with stability, security and scalability in mind. The use of different logical tiers allows for the full scalability of the system by using separate web, application, transactional database and relational database physical tiers (servers or server clusters). A single multi-tiered environment can host an unlimited number of concurrent clinical studies. Additionally, our hosting is based in the United States, Canada, Europe and soon in Asia-Pacific. This allows you to offer sponsor customers a choice of where to have their data stored.


SECURITY & CERTIFICATIONS

Security is the foundation of our Unified Data Management platform. Ensuring the confidentiality, integrity and availability of customer data is of the highest importance at REDCap Cloud. As such, we have embedded security best practices throughout the organization and in our products.
REDCap Cloud provides a wide range of information regarding its hosted IT environment to customers through a variety of white papers, reports, certifications and third-party attestations. This information assists customers in understanding the controls in place relevant to the REDCap Cloud products and services they use and how independent auditors validate those controls. This information also assists customers in their efforts to account for and to validate that controls are operating effectively in their extended IT environment.
REDCap Cloud complies with the following standards and has received the following certifications:

ISO 27001 Certified
21 CFR Part 11 Validated
CDISC Compliant
HIPAA Compliant
GDPR Compliant
MedDRA & WHODrug Certified
FISMA Compliant
SOC || Pending 4Q18
HITRUST Pending 4Q18

We will continue to obtain the appropriate security certifications and conduct audits to
demonstrate the security of our products and services.


VALIDATION AND COMPLIANCE DOCUMENTATION

The REDCap Cloud Validation and Compliance Virtual Data Repository provides on-demand access to IQ documentation as well as a set of templates necessary to efficiently and cost-effectively validate the implementation of REDCap Cloud. The overall solution provides auditors with the necessary tools to conduct a virtual audit, which saves time and money for all stakeholders.

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