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Type 1 Diabetes Mellitus Simulation
The
Epsilon Group provides simulation services for validation of
novel treatment strategies for FDA approval of
Investigational Device Exemption. The T1DM Metabolic
Simulator is a computerized modeling system that has been
accepted by the U.S. Food and Drug Association (FDA) as a
substitute for animal trials in the pre-clinical testing of
control strategies in T1 Diabetes Mellitus. Nearly 50
academic and 10 industrial sites and the over 100
biopharmaceutical and medical device companies actively
developing medications and glucose control strategies to
treat diabetes will have access to simulation services in
early development stages. These simulations save years and
millions of dollars in pre-clinical development and
testing. Currently 4 Investigational Device Exemptions
(IDE) have been granted based on in-silico simulations on
the FDA-accepted in-silico population (n=300 subjects; 100
pediatric, 100 adolescent, and 100 adults subjects).
Additionally, Epsilon provides access to the training
version of the T1DM Metabolic Simulator for the wider use by
the diabetes research community. Technical and training
support and upgrades of the Metabolic Simulator are
available to academic and industry scientists with current
access to the test version and test population (n=30
patients; 10 pediatric, 10 adolescent and 10 adult in-silico
subjects). Web-based access to support and training will
support extensive use and availability of the training
version of the simulator.
Project Management
At Epsilon, we recognize that managing a project efficiently and
effectively is essential for achieving our client’s goals. The
Project Manager is responsible for the usual:
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Overall project planning, development, and scheduling,
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Development and execution of a communication plan
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Identification of problem areas, and
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Providing informed solutions and assistance to the client
…to ensure that deliverables are delivered on time, within
budget, and in accordance with the project proposal and client
need.
What sets Epsilon apart is that we recognize that every project
presented to us is unique and deserves a novel approach. Our
mission at Epsilon is to conduct scientifically-sound research
following quality-driven Project Management SOPs, WHILE catering
to the uniqueness of our client’s research and
information needs. Epsilon conducts projects in accordance with
ICH Good Clinical Practice Guidelines.
Protocol Design
With over 25 years of research experience, our staff understand
the importance of protocol design for the effective
implementation of clinical studies and surveys. To ensure an
effective Institutional Review Board review for study approval,
we work with our clients to develop a scientific protocol that:
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Summarizes and synthesizes the available research to provide
justification for the study.
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Evaluates prior research for relevance to the research
question under study.
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Details study procedures and instrumentation that can be
best managed in today’s busy hospital environments.
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Identifies important metrics, variables and endpoints.
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Specifies the standard and novel analytic techniques to be
used to answer the study questions.
IT Integration
Epsilon has partnered with Medical Automations Systems (MAS) to
incorporate biomedical data warehousing and data management
technologies, data analytics, and clinical reporting solutions
to support physician and nursing research and practice in all
healthcare arenas.
Transformation, efficiencies, collaboration, and expense
reduction are looming issues pressing pharmaceutical,
biotechnology, and medical device companies to change the way
they conduct research. Growing costs, intensifying competition
and the significant growth of the healthcare industry forces
companies to look toward information technology to help address
their research and surveillance needs in efforts to improve
market share.
MAS/Epsilon’s primary product is the data management and
analyses of point-of-care device data. With access to
point-of-care clinical data through the Remote Automated
Laboratory System (RALS®), clinicians can make timely decisions
in disease management based on evidence of patient response
trends. Through established relationships with champion
clinicians and access to point-of-care data collected in over
1,500 hospitals, Epsilon is positioned to provide opportunities
to pharmaceutical and medical device companies in collaborative
research. The anticipated results from this effort are
evidence-based healthcare outcomes benchmarking derived from
best practices.
Epsilon is engaged in sponsored biomedical research conducted in
partnership with Hospital Centers of Excellence in Diabetes and
Related Disease Management. We offer a suite of software
applications targeted to specific customer needs, high-level
consulting services and a central repository of valuable
research and benchmarking data available on a subscription
basis.
Data Management Services
Every Epsilon project includes superior clinical data
management. From a small survey to highly complex Phase
IV trial, we design a regulatory compliant database for
data entry, processing and tracking of the data, and
queries. Our statisticians will work with you to develop
a data management plan that will assist you in achieving
your study goals. Our Data Management Services include:
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Case Report Form (CRF) design
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Database design and validation
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Data edit programming with SPSS®
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Query generation and resolution
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Quality control of the data
Statistical Analysis Services
Epsilon statisticians are focused on developing statistical
plans that best support our client’s goals while adhering to
strict regulatory requirements. Our statisticians are skilled in
the following:
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Study design
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Protocol development and preparation
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Sample size estimation
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Randomization
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Data analysis
Additionally, our statisticians have contributed to the
development of the Continuous Glucose – Error Grid Analysis (CG-EGA)
CD-ROM available for purchase from Epsilon. Click here to
View a Demo.
T1DM Metabolic System
in-silico
Model Simulation Services
The T1DM Metabolic Simulator
is a computerized modeling system that has been accepted by the
U.S. Food and Drug Association (FDA) as a substitute for animal
trials in the pre-clinical testing of control strategies in
T1DM.
Epsilon provides simulation services for testing and validation
of novel Type 1 Diabetes treatment strategies in development
within the medical scientific, pharmaceutical and device
technology community. Epsilon provides and supports the T1DM in
silico training version of 30 patients, and also contracts to
run simulations for testing early in the research and
development stages. Additionally, Epsilon provides simulation
services for FDA approval of Investigational Device Exemption.
Nearly 50 academic and 10 industrial sites and the over 100
biopharmaceutical and medical device companies actively
developing medications and glucose control strategies to treat
diabetes will have access to simulation services in early
development stages, and on the FDA-approved in-silico population
(n=300 subjects, 100 pediatric, 100 adolescent, and 100 adults
subjects) for FDA IDE submission.
Epsilon distributes and supports the T1DM training version with
the aim to simplify access to the training in the use of the
T1DM Metabolic Simulator for the wider diabetes research
community. Technical and training support and upgrades of the
Metabolic Simulator will be made available to the investigators
at academic and industry sites with current access to the test
version and test population (n=30 patients; 10 pediatric, 10
adolescent and 10 adult in-silico subjects). Ultimately the goal
is to provide Web-based access to support and training to
promote extensive use and availability of the training version
of the simulator.
Expert Consultants
Epsilon retains consultancies to support access and ongoing
collaboration with the primary scientists and engineers who
contributed to the creation of the model:
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Claudio Cobelli, PhD and
Chiara Dalla Man, PhD, University of Padova, Padova, Italy
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Stephan Patek, PhD, Marc
Breton, PhD, and Boris Kovatchev, PhD, University of
Virginia, Charlottesville, Virginia, USA
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Francis Doyle III, PhD,
Howard Zissel, MD, and Eyal Dassau, PhD, University of
California, Santa Barbara, California, USA
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Lalo Magni, PhD,
University Di Pavia, Pavia, Italy
Coming in 2011
Medical Writing Services
Our Medical Writing Team is skilled at producing comprehensive
clinical reports that are scientifically accurate and concise.
We have experience in many therapeutic areas, including
oncology, diabetes, diabetes-related disorders, as well as
point-of-care diagnostic technology (see Epsilon-assisted
publications). Epsilon Medical Writing Services include:
Epsilon SOPs ensure that all data remains confidential,
backed-up and secure.
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Type 1
Diabetes Mellitus Metabolic Simulation
Project
Management
Protocol
Design
IT
Integration
Data
Management Services
Statistical
Analysis Services
T1DM Metabolic
System in-silico model simulation services
Medical
Writing Services |
