semanticbits.com

As an active member of the CTMS Workspace, SemanticBits team members are involved in the CTMS SIGS:

In addition, the SemanticBits team has in-depth knowledge of caCORE and caGrid, which provide the basic underpinnings for the CTMS applications. SemanticBits and/or its employees have worked on the following critical caCORE and caGrid projects:

SemanticBits has an excellent track record of delivering projects that comply with the caBIG compatibility guidelines. In fact, several of our employees were instrumental in drafting the caBIG compatibility guidelines. Our expertise comes from working on several high-profile projects across various workspaces in the caBIG, often collaborating with organizations engaged in cancer research. Organizations we've worked with include Duke University, Northwestern University, Mayo Clinic, and Wake Forest University; projects we've been involved in include CTMS, Architecture and VCDE, and Integrated Cancer Research (ICR).

The tools we are developing in caBIG are being successfully adopted by a number of organizations. Our expertise has led us to provide consulting services to commercial vendors to help them make their products caBIG silver-level compatible. We also provide consulting services to cancer centers and other organizations engaged in cancer research to help with the installation and deployment of caBIG infrastructure and tools.

The SemanticBits team has extensive experience in the area of adverse event documentation and reporting. In 2006, our company began development of the Cancer Adverse Event Reporting System (caAERS), which is scheduled for public release on March 3, 2008. The caAERS application includes functionality to cover the following:

• Routine AE and Serious AE (SAE) data capture
• Creation and submission of FDA IND Safety Reports (including MedWatch and CIOMS)
• Creation and submission of AdEERS expedited Adverse Event reports
• Creation and submission of DCP SAE reports
• Handling of both investigational (IND) and commercial agents.
• Support for multi-modality studies (involving Agents, Surgery, Radiation, Medical Devices, and combinations)

In developing caAERS, the SemanticBits team has sought to deliver a tool that will enhance patient safety, simplify and improve adverse event tracking processes, increase reporting compliance, and enable greater AE data sharing and analysis.

Throughout the project, we have worked closely with the Cancer Therapy Evaluation Program (CTEP), Division of Cancer Prevention (DCP), Northwestern University, Mayo Clinic, Wake Forest University, City of Hope, and the AE SIG.In addition, we have received valuable input from Subject Matter Experts at Duke University, Harvard University, and a number of Cooperative Groups, including CALGB, ECOG, and RTOG.

As part of the caAERS development process, SemanticBits has worked hand-in-hand with representatives from several pivotal groups in the adverse event reporting field, including the Cancer Therapy Evaluation Program (CTEP) and the Division of Cancer Prevention (DCP). Highlights of our collaboration include the following accomplishments:

• Working with the AdEERS software development team, we built, tested, and deployed a feature to permit electronic submission of expedited reports from caAERS to AdEERS. The development of this feature required the encoding of over 80 rules to ensure the accuracy, completeness, and integrity of the data being submitted.
• Working with CTEP and caBIG Adopters, we're developing a process for translating protocol-specific conditions and exceptions, which can be incorporated throughout a typical protocol brochure, into a formal, easy-to-ready, tabular format for standardization and use in creating a library of rule sets that can be plugged into caAERS and used for automating the assessment of expedited reporting requirements.