SBIR-STTR Award

OpenClinica: Open Source Platform for Clinical Research
Award last edited on: 7/19/10

Sponsored Program
SBIR
Awarding Agency
NIH : NCRR
Total Award Amount
$1,319,346
Award Phase
2
Solicitation Topic Code
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Principal Investigator
Cal T Collins

Company Information

OpenClinica LLC

460 Totten Pond Road Suite 200
Waltham, MA 02451
   (617) 621-8585
   contact@openclinica.com
   www.openclinica.com
Location: Single
Congr. District: 05
County: Middlesex

Phase I

Contract Number: 1R43RR019837-01
Start Date: 00/00/00    Completed: 00/00/00
Phase I year
2004
Phase I Amount
$178,920
The goal of this project is to investigate the technical feasibility and commercial potential of a platform (PhenoNet) for custom phenotypic data repositories that encourages adoption of phenotypic data standards and exchange of knowledge across sources. Phenotypic data collection today generates large quantities of heterogeneous data and it does not yet match the analogous efforts in genomic research in terms systematization or throughput. Freimer and Sabbati's recently proposed Human Phenome Project will require "an enormous coordinated effort, to obtain phenomic databases that are powerful, standardized, and comprehensive" (2003). PhenoNet will be used by individual investigators or laboratories and will provide users with tools to administer projects, enter data, track progress, and create complex queries. The true significance of the system, however, will be in enabling users to define and map their datasets to accepted standards for phenotypic data, and then share and integrate datasets via these standards. The platform will increase the pace at which research can occur by streamlining the dataset design process, facilitating increased accuracy and throughput in phenotypic data collection, and providing detailed auditing and tracking of the data collection processes. The system will provide an enhanced ability to store, manipulate, and share phenotypic data. An adjunct PhenoNet "Registry" will serve as a centralized directory of investigators with standards compliant datasets, enabling researchers to find collaborators and integrate disparate data based on common mapping to accepted standards. In doing so, PhenoNet will allow for novel research designs by facilitating data mining of detailed phenotypic datasets in ways that are currently prohibitively complex. By examining data in these new ways, investigators will be able to produce more granular characterizations of expressed traits that can lead to more effective analysis when studying genetic or environmental influences on disease as well as refinement and better understanding of disease phenotypes. Phase I will include analysis and design of all major components of the system as well as construction and evaluation of a prototype system in the field of psychiatric and neurological research.

Thesaurus Terms:
data collection, genetic registry /resource /referral center, phenotype, technology /technique development data management, information system, meta analysis, neurology, psychiatry

Phase II

Contract Number: 5R43RR019837-02
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
2005
(last award dollars: 2010)
Phase II Amount
$1,140,426

We believe a key barrier to transforming clinical research is the lack of open, integrated, transparent technology solutions that address bottlenecks in information integration and business process management. Our viewpoint is supported by a recent Forrester Research study that identifies proprietary software as "one of the biggest barriers" to interoperability in the health IT environment, and suggests wider use of open source software to address integration challenges. I This project will build on Akaka's OpenClinica platform, the leading open source clinical research solution, to develop a broad-based open source software infrastructure that enables interoperability in heterogeneous clinical and translational research, and to develop targeted commercially-supported open source solutions from this infrastructure. It will: Integrate research data across distributed heterogeneous data sources, even data from legacy sources with poor interfaces and data documentation. Automate exchange of information with other systems in the healthcare and clinical research enterprises via semantically harmonized domain models and standardized messaging interfaces. Facilitate transition of paper-based processes to electronic systems for electronic data capture of case report forms (CRFs) and patient diaries (ePRO, or electronic Patient Reported Outcomes). Improve research management and monitoring in a Good Clinical Practice-compliant environment. The resulting solution will advance the capabilities of the clinical and translational research enterprise and empower collaborative research at Academic Health Centers (AHCs), government agencies, Contract Research Organizations (CROs), and the biopharmaceutical industry. It will increase the throughput and efficiency of clinical research, operate reliably in heterogeneous environments, and enable new types of research by bringing together disparate research tools and data