the world’s only Medical Research Organization (MRO) that accelerates
medical device development through integrated laboratory testing,
clinical research and regulatory consulting services, announced today
the launch of its In Vitro Diagnostic (IVD)
development business to provide global manufacturers a proven
resource for expedited commercialization outcomes delivered via NAMSA’s
“Uniquely IVD” regulatory, quality and clinical research services.
“The IVD industry is expanding more quickly than ever, outpacing medical
device industry growth in several geographies, and is expected to reach
$69B globally by 2024 (GlobalData).
Due to the increased demand by patients and healthcare providers for
more rapid diagnoses and treatment plans, the need for novel and
highly-accessible IVD products will only intensify. Sponsors, who have
limited options for IVD-focused Contract Research Organizations (CRO),
will now benefit from this new service offering and the knowledge gained
through our presence in every major IVD marketplace in the world,”
commented Katie Schaaf, General Manager of NAMSA’s IVD business.
The IVD industry has experienced an increase in regulatory scrutiny with
the publication of the European Union’s In Vitro Diagnostic
taking effect May 2022, in addition to a growing need for clinical
evidence to support international regulatory approvals. NAMSA,
frequently collaborating with global regulatory bodies to understand
expectations and new regulations, knows how to navigate the
international regulatory landscape and is recognized by authorities as
delivering trusted, highly-reliable IVD development outputs for
regulatory, quality system and clinical research initiatives.
“We are uniquely positioned to empower IVD
manufacturers with accelerated, cost-effective development outcomes.
Unlike other CROs, our team of IVD experts are solely focused on
providing proven solutions for the unique challenges and needs of In
Vitro Diagnostic technologies. This not only allows manufacturers to
achieve clinical endpoints more quickly, but also helps them make more
informed decisions that fast-track global delivery of life-changing IVD
technologies,” concluded Ms. Schaaf.
For a complete listing of NAMSA’s IVD solutions and service offerings,
please visit: https://www.namsa.com/ivd-cro-overview/.
Meet with NAMSA
Global manufacturers interested in NAMSA’s proven IVD services are
invited to meet with our experts at the upcoming American Association
for Clinical Chemistry (AACC) Annual Scientific Meeting in Chicago, Ill.
from July 31 – August 2. Click
here for more information, or to sign up for a complimentary
Additionally, NAMSA will be in attendance at the following conferences
and trade shows. Please check our events
webpage for regular updates:
a Medical Research Organization (MRO), accelerating medical device
product development through integrated laboratory, clinical and
consulting services. Driven by our regulatory expertise, NAMSA’s MRO®
Approach plays an important role in translational research, applying
a unique combination of disciplines – consulting, regulatory,
preclinical, toxicology, microbiology, chemistry, clinical and quality –
to move clients’ products through the development process, and continue
to provide support through commercialization to post-market
requirements, anywhere in the world.
NAMSA operates 13
offices throughout North America, Europe, the Middle East and Asia,
and employs 1,000 highly-experienced laboratory, clinical research and
regulatory consulting Associates.
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