How much do you know about running your clinical trial management system (CTMS) in the cloud? How does it compare to implementing a CTMS on-premises? View this infographic to learn more!

1. Tip
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Clinical Trial Management Systems
Fact
Fiction
A CTMS can be implemented faster in the cloud than on-site
Claim #1
Pre-qualified data centers
Due diligence may be reduced to reviewing the hosting
vendor’s most recent audit report on the data center
Pre-qualified servers that can be used immediately
No waiting for Procurement to purchase the servers,
IT to install them, and Validation to qualify them
Pre-qualified CTMS templates that can be used to clone
new environments
Cloning alone can save several implementation days
Pre-qualified clone templates can bypass the need for
IQ and/or OQ
Fact
Fiction
Sources of cost reductions:
Pre-qualifications of vendors, hardware, and template
environments
Reduced need for internal resources
Hosted, pre-configured CTMS “accelerator” option
Shared hosting option
“On-Demand” option
Cloud / Hosting / SaaS:
Factor
Fiction
A CTMS can be implemented
less expensively in the cloud than on-site
Claim #2
Ongoing costs for cloud/hosted CTMS solutionsare higher than for on-site solutions
Claim #3
Many hosting vendors design their hosting fees to include:
Unlimited end-user support
Bug fixes for client-specific configurations
System performance monitoring
Hardware maintenance
Hardware upgrades
When calculating the costs of these services and the
resources needed to provide them (people, time,
software, expertise), monthly hosting fees can be lower
than the equivalent in-house costs
Fact
Fiction
Hosted applications and data are, by design, available
through a web browser from any computer connected
to the Internet
No need to install software on your machine to access
the system
System uptimes vary from vendor to vendor, but some
are up over 99% of the time
Hosting vendors schedule system maintenance outside
of standard business hours
Unplanned downtime is minimal because hosting vendors
are experts in hosting; they know what to do and when to
do it to keep systems healthy
CTMS data stored in the cloud can be accessed at any time
Claim #4
Fact
Fiction
CTMS data in cloud/hosted systems is not secure
Claim #5
While it is difficult to secure data per industry standards
in a true “cloud” environment, hosted data can be easily
secured
Hosted systems can live behind firewalls that require VPN
to access
Hosted systems can be securely deployed over the
Internet using SSL encryption
Hosted systems can work with an organization’s Active
Directory authentication process
Hosted systems can be set up to meet each organization’s
data security policies and procedures
Fact
Fiction
Data can be migrated from other systems into a hosted
CTMS just like an in-house CTMS
Hosting does not limit data migration methods or sources
CTMS data migration sources can include:
Spreadsheets
Access databases
Homegrown applications
Previously-used CTMS solutions, whether hosted or in-house
Other hosted or in-house systems
Data from other systems cannot be migrated to
CTMS solutions in the cloud
Claim #6
Fact
Fiction
CTMS solutions in the cloud cannot beintegrated with other systems
Claim #7
Hosted CTMS solutions can be integrated with other systems
just like an in-house CTMS
Hosting does not limit integration methods or types of systems
CTMS integrations can include:
EDC or IVR (import subject and subject visit data)
Financial (export payment requests, import processed
payment details)
Safety (automatically trigger serious adverse event creation)
EDMS (auto-link CTMS document tracking records to
electronic document storage records)
Clinical Data Warehouse (create dashboards and reports
based on key metrics and performance indicators)
CROs (Import subject visit information and site visit/trip report information)
Fact
Fiction
Varies from vendor to vendor and product to product,
but some vendors/solutions still allow organizations to
perform administrative functions, such as:
User role creation
User account maintenance
Report template modifications
Dropdown list modifications
Choosing a hosted CTMS means relying on the
vendor for system administration tasks
Claim #8
Fact
Fiction
Systems in the cloud can be configured and/or customized
Claim #9
Whether hosted or on-site, a configurable CTMS (not all
are configurable) can be configured and/or customized
to meet each organization’s needs
Hosting does not limit the ability to configure or customize
a CTMS
Fact
Fiction
While true “cloud” is very challenging to validate, opting
for a hosted system does not hinder the ability to validate
or maintain a validated state
However, there are some additional considerations for
hosted systems and additional steps organizations should
take to ensure the integrity, security, safety, accessibility,
and compliance of hosted applications and data
Hosted CTMS solutions cannot be validated
Claim #10
As mentioned in #2,
some hosting vendors even offer
pre-configured CTMS “accelerators,”
which reduce the need for custom
configurations (but do not prevent the ability
to make them)
Tip Tip: Good CTMS
hosting vendors/solutions provide
all of the services that require IT
expertise while empowering organizations to
be in control of system use activities
Fact
Fiction