Biomedical Informatics & Support Services

Biomedical Informatics has become a technology essential to clinical and translational research.  Some reasons include:

• the widespread implementation of clinical information systems by many medical centers
• the need to acquire and integrate data from multiple sources in clinical and population studies
• the explosion in the amount of high-throughput genomic and proteomic data being produced
• the increasing use of highly data-intensive imaging studies in clinical research
• the need to transmit large amounts of information and data to a large number of users in diverse settings when translating clinical research to the practice setting 

To meet these challenges, the Biomedical Informatics Core focuses on the development and integration of many different informatics capabilities at Yale.

The mission of the informatics core is to facilitate and promote clinical research by working with researchers to provide consultation, assistance and direction on data acquisition, storage, retrieval, management. Supported with a variety of software and hardware, the Core provides investigators and their staff with tools and resources necessary to enter, maintain, and retrieve clinical research data.

Advanced Informatics Activities

The advanced informatics activities are based in the Yale Center for Medical Informatics (YCMI). The YCMI serves as a focus for training, research, and institutional computer systems development and support for a range of computing and informatics projects.

The advanced informatics activities build centrally on Trial/DB, a powerful, flexible, Web-accessible database that uses electronic case report forms (eCRF) to support clinical trials and clinical research. Trial/DB is currently being used at Yale to support clinical trials and clinical research in several clinical domains including cancer, cardiology, endocrinology, and psychiatry. Several Yale-based trials involve multi-institutional collaborations where data is entered from multiple sites nationwide using Trial/DB Web interface with appropriate security and confidentiality safeguards.

Close Ongoing Work with Study Investigators and Data Managers

Implementing protocols using Trial/DB involves working closely with the individual principal investigators (PIs) of the various studies and their data management personnel. This work includes:

1. teaching these individuals how to use Trial/DB;
2. working closely with them to help them enter their studies into our system;
3. refining the system as needed to accommodate the specific needs of their studies;
4. providing troubleshooting backup when any problems occur;
5. helping them in the process of monitoring the collection of their data throughout the course of each study;
6. adapting our tools to support their reporting needs; and
7. working with them to export their data into statistical packages such as SAS and SPSS for analysis.

Data Management Guidance for Study Developers

As described above, we provide a variety of assistance for users who are preparing studies for which Trial/DB might be appropriate.

• We provide written guidelines describing the system and how it can be used to support different types of clinical research studies.
• We have an electronic version of material describing the system that can be adapted for inclusion into proposals.
• We encourage investigators to talk to us when they are formulating proposals to determine whether Trial/DB would be appropriate and how it might best be used for their particular study.
• We give periodic demonstrations of Trial/DB that interested investigators and their staff can attend, as well as ad-hoc demonstrations on request.

Informatics Core

The Informatics Core also provides operational support services to investigators involved in patient-oriented research. The operations focus is database design and management, programming, and computer systems administration including database servers and file server. Application/server software that is presently available in and maintained for investigators and their staff include: SAS, SPSS, Office Suite, Project, FileMaker, CAMP, ARP, WebCAMP, and TrialDB, and Oracle and SQL server databases. University and contracted vendors provide other software. Here is a partial list of software and resources:

• SAS: http://www.yale.edu/software/sas
• Microsoft Office products: GovConnection via Yale eportal

Biomedical Informatics Contact

• Dr. Cynthia Brandt
  Phone: (203) 737-5762
  cynthia.brandt@yale.edu
• Charles Lu
  Phone: (203) 737-2982
  charles.lu@yale.edu