Cloud / Hosting / SaaS:

Fact Fiction
or
Claim #1
A CTMS can be implemented fa ster in the cloud than on-site
Pre-qualified data centers Due diligence may be reduced to reviewing the hosting vendors 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

Clinical Trial Management Systems

Fact Fiction

Claim #2
ted n e m e l p e im b n a c S M -site n A CT o n a h t oud l c e h t n i vely i s n e p x e less
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

Fact Fiction

Ongoing costs

Claim #3
for cloud/hoste for on-site solut d CTMS solution ions s

are higher than

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

Claim #4
a sto t a d S M T C red e b n a c d u in the clo a y tim n a t a d e ccess e

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

Fact Fiction

Claim #5
CTMS data in c loud/hosted sy stems is not sec ure
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 organizations Active Directory authentication process Hosted systems can be set up to meet each organizations data security policies and procedures

Fact Fiction

Claim #6

ca s m e t s y s her t o m d o u r f o l a c e Dat h t n ns i o i t u l o s S CTM

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

ted a r g i m e b nnot

to

Fact Fiction

Previously-used CTMS solutions, whether hosted or in-house Other hosted or in-house systems

Claim #7
CTMS solutions integrated with in the cloud ca other systems nnot be
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

e h t n o g n i s rely n a e m S CTM d e t s o h sks a a t g n n i o s i t o a o r t h C inis m d a m e t r sys o f r o d n e v

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

Claim #8

Fact Fiction
Tip: Good CTMS

Tip

hosting vendors/solutions provide all of the services that require IT

expertise while empowering organizations to be in control of system use activities

Claim #9
Systems in the c loud can be co nfigured and/o r customized
Whether hosted or on-site, a configurable CTMS (not all are configurable) can be configured and/or customized to meet each organizations needs Hosting does not limit the ability to configure or customize a CTMS

Tip

Fact Fiction

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)

Claim #10
Host ns c o i t u l o s S ed CTM a d e t a d i l a v nnot be

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

Fact Fiction

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