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vendors. While all of these productivity aids are useful, they do not
add new value to the PV function. So, the findings could mask relative
immaturity in AE case intake automation.
To determine how far along organizations are with PV automation
generally, and the specific areas they have advanced the most, the
research asked what else companies had automated or planned to
automate within the PV function.

Current Process Automation
Clinical and medical information compilation (both mentioned
by almost two thirds of respondents, rising to up to 80% among
respondents in product safety roles) emerged as the most
advanced areas for process automation, with almost two-thirds of
all respondents saying facilities for this were already in place. Use of
automation in standard document compilation and product quality
compliance information was also common, cited as being in place at
over half of companies. Automated solutions for managing regulatory
intelligence information, literature screening, and auto-narrative
generation were prevalent for more than four in 10 organizations.
While most respondents claimed their organizations were planning
an automated solution for AE case intake within the next year, the
survey indicated a number of practical barriers likely to inhibit
progress - the top three being IT-related challenges. Respondents
revealed that an inability to validate new systems (cited by 41%), a
lack of familiarity with AE case intake technology options (indicated
again by 41%), and inadequate IT infrastructure (cited by 38% across
all sizes of organization) stood in the way of automating these vast
and largely manual workloads.
There is a strong perception, especially among PV professionals, that
PV automation equates to a rise in AE reporting volumes. A followup question confirmed that respondents see this as a benefit of
automation. The greater an organization's capability for capturing
reliable information quickly, efficiently and effectively, the higher the
volumes of data that teams will be able to process - and the greater
the likelihood of important cases being identified and analyzed.
Across all company sizes, the top three benefits of PV automation
(jointly) were seen as improved compliance; higher reporting
volumes; and speed.

SME Efficiency Benefits
There were differences in perception between small and large
pharmaceutical organizations, however. Over half of respondents
from SME rated improved efficiency as the primary benefit, followed
by speed of turnaround. For large companies, keeping pace with peers
and meeting compliance targets were deemed the main advantages.
Surprisingly only just over a third (35%) of all respondents cited the
potential for resource redeployment as a target benefit.
It is clear that many businesses are missing an opportunity to
manage PV workloads more effectively and cost-efficiently,
while optimizing use of skilled resources. Data quality, speed and |


completeness of reporting could all be improved by automating
adverse event data capture. Yet most respondents did not see an
absence of PV automation as a disadvantage. In fact, only 6% of all
respondents felt their organization would be 'very disadvantaged'
by a lack of PV automation.

Inertia and IT Limitations
While it would appear that pharmaceutical companies don't want
to miss out on the promise of AE case intake automation, inertia
and IT limitations may be preventing companies from transforming
the performance and cost-efficiency of their PV operations - and
from reassigning expensive professionals' time to tasks that add
greater value.
It appears to be very much the case that PV functions are widely
viewed as a cost center rather than a function that could add value
to the business. This is lamentable, given the scope for process
transformation that today's technology enables. Proven solutions
exist now which could transform the efficiency, effectiveness and
regulatory adherence of PV processes, without placing data at any
risk of being compromised in any way.
Meanwhile global players often prefer to build their own customized
solutions, keeping these shrouded in secrecy as though they might
offer some kind of strategic advantage. This is puzzling. While Big
Pharma clearly has the resources to develop its own solutions for
adverse event case intake and processing, companies would surely be
better off - financially and time wise - using ready-to-go tools which
have been tried and tested many times over.
The research reveals that the benefits of letting advanced technology
take the strain of AE data capture and PV information processing
and reporting aren't fully on the radar of senior management and
business stakeholders. PV professional and solution providers may
need to work together to communicate the numerous tangible
benefits linked to capturing the high throughput of case data in an
automated way.

Further Investigation Needed
The findings of this comprehensive transatlantic survey offers much
food for thought. The topic also deserves further investigation, to
discover why more companies are not proactively pursuing the chance
to empower frontline people - including healthcare professionals
and company personnel - to capture PV information directly into
reporting systems, using smart digital data capture solutions.
The full report, Pharmacovigilance Automation Adoption Survey -
UK & US - Key findings and discussion, is here https://www.arriello.

John Price, owner and MD of John Price PharmaSolutions LLC,
is a life sciences regulatory and safety veteran and consultant,
and an advisor to PV managed service provider Arriello.,

| October/November/December 2020


Table of Contents for the Digital Edition of PharmaceuticalOutsourcingQ42020

Editor's Message
Editorial Advisory Board
CN Perspectives
Social Media Connections
Insider Insight - Price
Insider Insight - Ventura
Contract Manufacturing
Supply Chain
Contract Manufacturing
Interview with Yourway
Supply Chain
Clinical Trials
Supply Chain
Analytical Testing
Supply Chain
Clinical Trials
Analytical Testing
Horizon Lines
Industry News
Advertiser's Index
PharmaceuticalOutsourcingQ42020 - Cover1
PharmaceuticalOutsourcingQ42020 - Cover2
PharmaceuticalOutsourcingQ42020 - 1
PharmaceuticalOutsourcingQ42020 - Editor's Message
PharmaceuticalOutsourcingQ42020 - 3
PharmaceuticalOutsourcingQ42020 - 4
PharmaceuticalOutsourcingQ42020 - 5
PharmaceuticalOutsourcingQ42020 - Editorial Advisory Board
PharmaceuticalOutsourcingQ42020 - 7
PharmaceuticalOutsourcingQ42020 - CN Perspectives
PharmaceuticalOutsourcingQ42020 - Social Media Connections
PharmaceuticalOutsourcingQ42020 - Insider Insight - Price
PharmaceuticalOutsourcingQ42020 - 11
PharmaceuticalOutsourcingQ42020 - Insider Insight - Ventura
PharmaceuticalOutsourcingQ42020 - 13
PharmaceuticalOutsourcingQ42020 - Contract Manufacturing
PharmaceuticalOutsourcingQ42020 - 15
PharmaceuticalOutsourcingQ42020 - 16
PharmaceuticalOutsourcingQ42020 - 17
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 19
PharmaceuticalOutsourcingQ42020 - Contract Manufacturing
PharmaceuticalOutsourcingQ42020 - 21
PharmaceuticalOutsourcingQ42020 - Interview with Yourway
PharmaceuticalOutsourcingQ42020 - 23
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 25
PharmaceuticalOutsourcingQ42020 - 26
PharmaceuticalOutsourcingQ42020 - 27
PharmaceuticalOutsourcingQ42020 - 28
PharmaceuticalOutsourcingQ42020 - 29
PharmaceuticalOutsourcingQ42020 - Clinical Trials
PharmaceuticalOutsourcingQ42020 - 31
PharmaceuticalOutsourcingQ42020 - 32
PharmaceuticalOutsourcingQ42020 - Roundtable
PharmaceuticalOutsourcingQ42020 - 34
PharmaceuticalOutsourcingQ42020 - 35
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 37
PharmaceuticalOutsourcingQ42020 - 38
PharmaceuticalOutsourcingQ42020 - 39
PharmaceuticalOutsourcingQ42020 - Analytical Testing
PharmaceuticalOutsourcingQ42020 - 41
PharmaceuticalOutsourcingQ42020 - 42
PharmaceuticalOutsourcingQ42020 - 43
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 45
PharmaceuticalOutsourcingQ42020 - 46
PharmaceuticalOutsourcingQ42020 - 47
PharmaceuticalOutsourcingQ42020 - Clinical Trials
PharmaceuticalOutsourcingQ42020 - 49
PharmaceuticalOutsourcingQ42020 - 50
PharmaceuticalOutsourcingQ42020 - Analytical Testing
PharmaceuticalOutsourcingQ42020 - 52
PharmaceuticalOutsourcingQ42020 - 53
PharmaceuticalOutsourcingQ42020 - Horizon Lines
PharmaceuticalOutsourcingQ42020 - 55
PharmaceuticalOutsourcingQ42020 - 56
PharmaceuticalOutsourcingQ42020 - 57
PharmaceuticalOutsourcingQ42020 - Industry News
PharmaceuticalOutsourcingQ42020 - 59
PharmaceuticalOutsourcingQ42020 - 60
PharmaceuticalOutsourcingQ42020 - 61
PharmaceuticalOutsourcingQ42020 - 62
PharmaceuticalOutsourcingQ42020 - 63
PharmaceuticalOutsourcingQ42020 - Advertiser's Index
PharmaceuticalOutsourcingQ42020 - Cover3
PharmaceuticalOutsourcingQ42020 - Cover4