KANSAS
CITY, Mo., April 26, 2022 /PRNewswire/ -- The
International Gaucher Alliance (IGA) and Cerner
Corporation (NASDAQ: CERN) announce that the GARDIAN registry
(Gaucher Registry for Development Innovation and Analysis of
Neuronopathic Disease) is now open for registrations, and the first
patient has already enrolled April 25, 2022. This registry,
owned by the patient community, is led by the new Cerner
EnvizaSM operating unit that offers data-driven
solutions and expertise that helps bring remarkable clarity to life
sciences' and healthcare's most important decisions.
Gaucher Disease (GD) is an autosomal recessive disease and the
most common Lysosomal Storage Disorder, with an incidence of about
1 in 100,000 live births. Three types exist: type I, the most
common; type II and III also called neuronopathic GD (nGD). Today,
GD has no cure; treatment options are available to address some
aspects, but none are specific to the neurological impairments of
nGD.
The GARDIAN registry will collect retrospective and prospective
clinical and health outcome data for patients diagnosed with Type 2
and 3 Gaucher disease. Caregivers will provide their perspective
for pediatric and some adult patients, as well as the impact of
caring for a family member with nGD. Patients and caregivers will
complete new patient and caregiver reported outcomes instruments,
which are the basis of the first nGD specific instruments
available.
"There remains huge unmet needs in care, support, understanding
and effective treatments for the neurological manifestations of the
disease. GARDIAN will play an important role into better
understanding the impact of the disease on patients and caregivers
and ultimately enabling improved quality of life and better patient
outcomes," said Tanya Collin-Histed,
CEO, International Gaucher Alliance.
Data collection will be made through Atom5™, Aparito's iOS
& Android-compatible web and mobile app platform, which can
capture eConsent, multiple, high-frequency data points from video,
voice, wearables and electronic patient reported outcomes (ePROs).
The Atom5™ global platform operates under ISO143485 QMS and ISO/IEC
27001 ISMS accreditations and is FDA CFR21 Part 11 compliant.
"We are excited to be part of this important patient-driven
initiative, and that our Atom5™ platform will play a central part
in generating insightful data which can support the whole
community," said Dr. Elin Haf Davies, CEO, Aparito.
The GARDIAN registry aims to provide a more comprehensive
understanding of the natural history of disease for nGD patients in
order to accelerate early diagnosis and care for patients.
Real-world evidence derived from GARDIAN will support compound
development and inform the feasibility, protocol design and
implementation of clinical trials.
"We are delighted to achieve this important milestone and look
forward to seeing the GARDIAN registry grow," said Michael Fronstin, global head of clinical,
Regulatory & Safety, Cerner Enviza. "Including patient and
caregiver input will help future treatments be truly patient
centric."
Cerner Enviza aims to accelerate the discovery,
development and delivery of extraordinary insights and therapies to
improve everyday health for all people globally. By
combining decades of innovation, life sciences knowledge and
collaborative research, Cerner Enviza provides data-driven
solutions and expertise that helps bring remarkable clarity to
life sciences' and healthcare's most important decisions. For more
information, visit www.cernerenviza.com.
ABOUT THE INTERNATIONAL GAUCHER ALLIANCE (IGA)
The IGA
is an international umbrella group representing the interest of
Gaucher patients and those of non-for-profit Gaucher patient groups
as well as rare disease groups throughout the world. While the IGA
has an office in England, the IGA
has almost 60 member associations around the globe. The IGA is a
registered charity. The Gardian registry will be under the control
of International Gardian Limited (IGL) a wholly owned subsidiary of
the IGA
ABOUT CERNER
Cerner's health technologies connect
people and information systems at thousands of contracted provider
facilities worldwide dedicated to creating smarter and better care
for individuals and communities. Recognized globally for
innovation, Cerner assists clinicians in making care decisions and
assists organizations in managing the health of their populations.
The company also offers a connected clinical and financial
ecosystem to help manage day-to-day revenue functions, as well as a
wide range of services to support clinical, financial and
operational needs, focused on people. For more information,
visit Cerner.com, Cerner Perspectives, connect on
Facebook, Instagram, LinkedIn, Twitter or join
the discussion on Cerner's podcast Perspectives on Health &
Tech. Nasdaq: CERN.
ABOUT APARITO
Aparito is a global health
tech company that brings clinical trials to patients and unlocks
real-world data through mobile apps, video assessments and wearable
devices. We provide innovative patient-centric solutions that
integrate required clinical and regulatory expertise to capture
patient data and develop digital endpoints for hybrid and
decentralised clinical trials.
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SOURCE Cerner Corp.