INFOGRAPHIC

The 9 Hidden Costsof Clinical Trial Disclosure

From system implementation to protocol registration and processassessment, hidden costs lurk at every step of the clinical trial
disclosure process. Not to mention that disclosure noncompliancecan risk sponsors incurring substantial regulatory ﬁnes.

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IMPLEMENTATION
Poorly executed system
implementation can lead to delayed
rollouts and months of validation
testing.

REGISTRY UPDATESTrial registries make an average of 75
technical and regulatory changes
annually.

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Validated software requires resources
for user acceptance testing which cancost the sponsor many weeks ofproductivity each year.

Many vendors charge additional fees
for annual technical support services.

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TrialScope Disclose provides
comprehensive validation
support including the documents,
evidence of automatedregression testing andexecution-ready test scripts.

TrialScope Disclose’s support
organization has earned a 94%
satisfaction rating the last year.
Comprehensive help-desk
services are included at noadditional cost.

PROTOCOL MAINTENANCE
Once a protocol is registered, it
requires repeated updates as any oneof a dozen data elements change,
often with a timed compliancedeadline.

TrialScope Disclose’s batch
maintenance automates the data
update process of multiple
studies concurrently, including
simultaneous submission to the
PRS system.

VALIDATION
Registry submissions rejected for not
meeting speciﬁc data validation
requirements are usually rerouted forreview and approval, adding time andrisk.

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Regular updates to the
TrialScope Disclose system anddisclosure rules engine areincluded with your subscription atno charge.

TESTING

4 SUPPORT

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TrialScope Disclose’s proven
implementation process has been
perfected across 30+ customers
and with a 100% track record of
on-time/on-budget rollout.

Submission and ﬁeld -level data
validation are ingrained in
TrialScope Disclose to ensure
successful submission, complete
compliance and avoid emergency
rework.

REVIEW & APPROVAL
To prevent releasing conﬁdential
information, draft disclosures must
undergo lengthy review and approval
processes that involve multiple,
usually senior-level stakeholders.

TrialScope Disclose optimizes andautomates review and approval
cycles to reduce stakeholder
burden and accelerate timelines.

REGULATORY UPDATESGlobal disclosure regulations arecontinuously evolving. There are 35+
registries representing more than 109
countries in which trials areconducted.

9TrialScope Disclose’s regulatory
intelligence processes
continuously track disclosure
regulations and codify these into
our disclosure application.

BENCHMARKING
Sponsors looking only at their data
have no solid basis for assessing
inefficiencies, which typically meansno process improvements are made.

TrialScope Disclose’s customers
can access a range of exclusive
benchmark reports that assesssponsor processes against
benchmarks based on over 40%
of all industry trials.

TrialScope Disclose empowers clinical trial sponsors to do
more with their trial information, from ensuring disclosurecompliance and maximizing tria transparency to improving
patient education, engagement and trust.
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