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Minimise the potential for human error
As system management with psiXchange is kept to a minimum you reduce the potential for human error. Once you’ve defined the business process the human element is removed, leaving you free to monitor the distribution status from our easy to use central dashboard.

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Increased compliance through automation
Small mistakes often lead to big consequences. That’s why companies and regulators alike can get nervous when key processes have multiple steps that require constant manual intervention. Automation with psiXchange means that the process is transparent and controlled.

Accepted by all recipients
With flexible delivery methods (including e-mail, FAX, courier and Smart Portal) psiXchange allows you to send your safety documents to anyone, including sites, ECs, IRBs. HAs and others

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Clear oversight of your processes
In psiXchange you can maintain a single view of all the distinct actions and rates of progress behind each specific process. The easy to use dashboard means that you experience faster and more informed decision-making. With easy access control you can give access to CROs as needed for specific studies.

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Assured repeatability
Implement powerful business logic with psiXchange to give you complete certainty of outcome – The country rules that drive the SUSAR distribution are audit proof allowing you to see why a document was sent on a specific date.

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Proactive management
The compliance reports (with drill down to site level) allow you to see if there are training needs that could indicate other problems with that recipient or site.

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Easily work with existing data
psiXchange connects with your Safety Database and CTMS. It does this with a minimal technology and process footprint that then uses the power of the data relations to drive process execution.

Cost savings
Full automation leads to a more streamlined process. This means reduced efforts and reduced costs.

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Greater compliance,
with a complete audit trail
psiXchange significantly reduces the operational costs associated with producing full audit trails and compliance documentation. For regulated industries, these “must have” brings complete reassurance. Flexible reporting, with users’ personal dashboards according to their needs, means that the right information is readily available.

Comparison Table

Below is a table that shows the benefits psiXchange offers to all our users.
Subject/Item
Standard Portal Manual distribution Importance Notes
Method of distribution email/fax/courier/E2B email/fax email/fax/courier/E2B 2
Available methods for document distribution
Time per Submission super fast fast very slow 1
Time required for a single submission using the system
Internal efforts very low medium very high 3
Overall workload associated with submitting a single document to all applicable recipients
Recipients unlimited limited, e.g. sites only unlimited 2
Recipient types that can be addresed, e.g. Sites, RAs, local and central ECs, CRO, Sponsor…
Cost low medium very high 3
Costs include workload for preparation of a document, sending it to all recipients including tracking, oversight and shipment
Oversight very good intermediate poor 3
General oversight the system allows e.g. study specific, drug specific, cross reporting…
Compliance very good good low 3
General compliance of the system including tracking and acknowledgement of submissions
Traceability very good good poor 2
Dashboard functionality including reports, charts, or export in Excel sheets…
Auditability low low high 2
Effort to fully audit the process and the actual distributed documents when using a system
User friendliness users very good very good good 2
How easy is it to work with the system for standard users
User friendliness admins good good N/A 2
How easy is it to work with the system for admin users
Recipient effort low medium high 1
Effort the recipient must take to get his document e.g. login required? Manual efforts on receipt? Active document search?
Security very high high low 3
The amount of effort required to illegally obtain confidential data
Flexibility very high low intermediate 1
Flexibility allows system changes even when the system is fully configured and live
Adoptability very good intermediate N/A 1
Ability to reflect current customer processes used for distribution of documents, e.g. including decission making for submission of Events of Special Interest
Training effort admins high high N/A 1
Administrators need to be trainend on administration in addition to standard use of the system
Training effort user intermediate intermediate high 2
Standard users need training for day to day business
Training effort recipients N/A medium N/A 2
Recipients need training in case there are additional tasks other then daily communication, e.g. portal use to get to a document
Reminder management very good good poor 1
Keeping oversight on reminder notification *psiXchange can escallate reminders to CRAs
Escalation management very good poor poor 1
If a document was not received (e.g. fax turned off, mailbox not reachable) is there a way of using an alternative method for submission (automated)?
Cover letter creation automated manual manual 2
Is there a way to modify the cover letters accompaniyng a document?
Support of multilinguality very good medium very good 1
*depending on the available staff knowledge Different (local) languages of notifications and cover letters
Maintain recipients optional yes yes 2
Recipients data must be accurate all the time to ensure proper distribution of documents. Can this be done within the system (within company for manual distribution)?
Maintain reporting requirements optional no yes 3
National reporting requirements need to be up to date to ensure compliance. Can this be done completely within the system (within company for manual distribution)?
Integration of client systems full no partial 2
Is a communication with available systems possible, e.g CTMS, Safety database, regulatory compliance system...
Supporting local forms yes no yes 2
Some recipients require additional local forms to be added to a document. An example would be the CTIMP Safety Report Form that is required by UK main Research Ethics Committees
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