SOLUTION BRIEF

Leveraging digital
measurements inclinical trials
ZS Digital Evidence Generation

Entering a new era in drug
development and validation via
digital measurement inclusion

An unsustainable approach

The adoption of digital measurements derived fromdigital sensors and devices in clinical trials has beensteadily increasing. These measurements improve
clinical trials by capturing novel or more granular
data, which is often more objective and representativeof real-world outcomes. At the same time, devicesupported decentralized trials can reduce the needfor data collection at in-person visits, thus reducing
the participant burden of travel.

32%

While digital sensor and device-derived measurements
have yet to be included in label claims, regulatory
and industry indicators point to a high likelihood ofthat happening in the next three to five years. We areseeing good momentum of that happening here due to:• Digital endpoints (primary and secondary) wereused in 14 phase 3 pivotal trials since 20151• There is a 14% year-over-year average increase in
the use of sensors in clinical study settings
12

DiME Society — Endpoint Library, 2CTTI Feasibility Study (2013-2019)

3ZS-Tufts survey, 4Clinical Leader

Despite the previously mentioned tailwinds, the life
sciences industry still contends with speedbumps inutilizing these digital measurements.

Of participants in clinical trials find digital technology
too difficult to manage310+
Systems or sources that sponsors and CROs arerequired to manage or oversee, on average, for phase
3 or 4 studies 4
Current approaches to device and sensor inclusion
often fall short of mitigating the associated risks toensure successful remote monitoring technology inclinical programs.
Modernizing the paradigm of conducting clinicalresearch
ZS Digital Evidence Generation improves outcomesfor clinical trials by connecting a fragmented digitallandscape.

SOLUTION BRIEF

Our solution
ZS’s Digital Evidence Generation consulting and strategy services and ZS Connected ResearchTM — a compliant
and configurable platform that is purpose-built to advance patient data capture and help clinical study teams
incorporate novel digital measures into their studies and research initiatives.
Simplified participant
experience

Device and biosensor data
ingestion and conversion

Publication and regulatory
submission support• Integrations with a curated• Ingestion and transformation• Seamless extraction ofportfolio of validated devices
with proven usability and clinicalvalue

of device-generated data formeasurements, such as activity
and sleep monitoring

study data for analysis inyour statistical computing
environment• A seamless and engaging digital• Compliant data standardization• Advisory services on peer-

onboarding experience forparticipants

and harmonization for both
regulatory submissions andexploratory analysis• Logistical and technical support
for participants and clinicalresearch staffreviewed journal publication
pathways, exploratory analyses
and regulatory pathways• Capability to directly pass sensor
data through to client dataenvironments

Value to you
Human-centric

Integrated

Quick to deploy

Out-of-the-box
analytics

Learn more: zs.com

About ZSZS is a management consulting and technology firm focused on transforming global healthcare and beyond. We leverage
our leading-edge analytics, plus the power of data, science and products, to help our clients make more intelligent decisions,deliver innovative solutions and improve outcomes for all. Founded in 1983, ZS has more than 12,000 employees in 35 offices
worldwide.

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