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Novo Annual Review 2016
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eresearch technology global leader in solutions for
clinical
outcomes
data
capture e rt is the leading global provider of electronic
data
collection solutions for
clinical
development programmes.
ert
?s cloud-based solutions capture quality efficacy and safety endpoints, harmonise
data
from any
clinical
source system, and deliver real-time insights for optimal trial performance while ensuring patient safety. novo holds 30% of the institutional equity in
ert
plus a portion of the debt. we partnered with nordic capital for this transaction, which was our first investment in a us- headquartered company with global business activities. advancing
data
collection, analysis and reporting
ert
?s combination of technology, services and consulting increases the accuracy and reliability of patient
data
and improves the efficiency of the
clinical
development process throughout the product lifecycle. the company operates in three main business areas: ? electronic
clinical
outcomes assessment (ecoa) comprises electronic questionnaires (e.g. probing on degree of pain) to track patient health status. questionnaires are administered by phone or tablet to track and collect patient-reported metrics. digital solutions are increasingly used over paper due to low costs, improved
data
quality and subject compliance as well as dynamic functions (e.g. suicide risk al
ert
s). ? cardiac safety involves the collection and interpretation of cardiac
data
using a connected ecg for use in drug safety testing. centralised digital solutions are increasingly taking over from paper
data
capture due to the higher
data
quality in automated readings (e.g. detection of short 10 milli- seconds abnormalities that ~80% of cardiologists miss).
ert
delivers ecg readings supported by proprietary analytics software and in-house cardiologist
data
evaluation. ? respiratory includes the collection and interpretation of respiratory
data
from connected spirometers for testing of the efficacy and safety of drugs. respiratory
data
is used as key end point to determine efficacy in respiratory diseases (asthma, copd, cf, ipf). it is also used for lung safety in other therapeutic areas. positive predictions
ert
has consistently been growing both revenues and profits by more than 10% per year, and the company is well positioned to continue benefitting from significant and rapid shifts in the market. three key factors account for
ert
?s positive prospects. first, regulatory and payer requirements to
clinical
trial sponsors are becoming ever more stringent and expansive. demand is increasing for further
data
elements ? many patient as well as physician reported ? to demonstrate patient benefits and overall cost effectiveness. second, electronic
data
capture improves accuracy, speed and cost. more than 80% of patient-reported
data
is still collected on paper, representing an enormous opportunity for
ert
. additionally, the us fda has issued guidelines stipulating that only electronically collected
data
can be used for labelling purposes. finally,
clinical
trial sponsors increasingly need scalable, dynamic and trusted solutions. at the same time as sponsors need additional functionality to interact with patients and physicians, the overall cost of
clinical
trials has never been higher, which increases operational risk.
ert
is the only large it solutions provider with a track record of zero failed studies. >50% of fda drug approv- als in past three years were based on
ert
-supported studies >50% of fda drug approvals in past three years were based on
ert
-supported studies. in may 2016, novo a/s acquired a minority stake in eresearch technology inc. (
ert
), a leading global provider of electronic
clinical
outcomes
data
collection for the pharmaceutical industry. the minority share was acquired from genstar capital for usd 1.8 billion. the acquisition was lead by private equity partner, nordic capital. 9000+ studies with 3 million patients have relied on
ert
solutions. 20 novo a/s 2016
data-ert-solutions-21.html
