Pharmaceutical Outsourcing Q2 2024 - 18

CLINICAL TRIALS
handed off between teams, ensuring a continuous flow of work,
resulting in increased productivity.
FTS strategies can be applied in a variety of ways to improve
productivity. They may be used to hand off tasks between
synchronized teams performing the same function. As an example,
when a pharmacovigilance (PV) team located in Asia completes their
workday, they can pass the baton to their European counterparts,
followed by a North American team, thereby achieving 24-hour
productivity in a single day to expedite critical tasks, ensure
compliance and keep projects on or ahead of schedule to drive
project success.
The FTS model also can be strategically applied between different
functional teams to hand off data to minimize bottlenecks. For
example, data collected from one region can be analyzed in real
time by cross-functional clinical data management teams operating
in another time zone, facilitating rapid decision-making and
enhancing overall operational efficiency. Or, as another example,
if a client based on the East Coast of the United States reviews a
document and submits comments at the end of the business day, a
medical writer based in Asia-Pacific can triage and incorporate those
comments to progress the document before the client is online the
following morning.
FTS models have long been successfully used in other sectors,
especially among technology organizations, to deliver uninterrupted
access to customer-facing functions. In the context of clinical
development functions, FTS models can be used to provide prompt
responsiveness to patient or sponsor questions, technical issues, and
urgent needs.
Additionally, by distributing workloads across teams providing
the same functions in different time zones, FTS models reduce
the burdens on individual teams, promoting a healthier work-life
balance, and ultimately enhancing employee engagement and
retention. The distributed nature of the model also provides built-in
risk management, as disruptions in a single location can be mitigated
by other sites continuing their operations to ensure uninterrupted
progress and maintain business continuity.
Furthermore, the model optimizes resource allocation. In a talent
market where demand far outstrips supply, strategically locating
various functions in different regions also can offer new access
to skilled clinical development professionals in different labor
markets. By strategically allocating teams-either between split-shift
functional teams handing off tasks at the end of the day or crossfunctional
teams handing off data-drug developers can tap into
both higher-cost and lower-cost labor markets to find the right talent
and ensure quality output.
Why Use an FSP Model for an
FTS Approach?
FSP partnerships are designed to offer a breadth and depth of
functional capabilities and teams around the globe, making it
the optimal outsourcing model to extract the full potential of FTS
solutions. In addition, staff sourced from an FSP partner's internal
talent pool already are vetted and trained, they can be mobilized
quickly to fill staffing and service gaps. FSP partners with a large
internal talent pool spanning many different functional areas and
the globe-including emerging markets-are especially well
positioned to rapidly deploy swaths of qualified employees to
support FTS engagements when and where they are needed. This
adaptability and global reach ensure clinical development functions
can operate seamlessly across time zones, even during peak
workloads, keeping timelines and budgets on track while ensuring
high-quality outputs. It also means drug developers can easily scale
their operations up or down to meet fluctuating demands without
the need for extensive internal infrastructure investment.
Furthermore, FSP partners with a wide global footprint bring valuable
expertise in navigating different regulatory landscapes. This is crucial
to ensure compliance with regulations and the safety and reliability
of clinical development and post-marketing surveillance processes
while optimizing productivity.
FSP relationships also bring a partnership mindset, fostering the kind
of collaborative global environment that encourages knowledge
exchange and cross-pollination of ideas across different teams
and locations-a requirement for any FTS environment to thrive. A
collaborative culture enhances communication and better enables
around-the-clock collaboration between global stakeholders. This
seamless flow of information and expertise further strengthens
decision-making, accelerates problem-solving, and ultimately
enhances the efficiency and effectiveness of clinical development
and post-marketing surveillance.
Essential FTS Best Practices to Ensure a
Smooth Workflow
Operationalizing an efficient and collaborative FTS environment
requires excellent communication, clear processes, and a robust
technology infrastructure. An FSP partner should have global
systems in place based on best practices. For example, teams need
to be tightly synchronized despite physical separation and time
zone differences. Communication channels such as technologyenabled
platforms, regular
virtual meetings, and established
standard operating procedures (SOPs) are needed to connect all the
dots. All team members also must have standardized training. As an
example, a pharmacovigilance (PV) team with split shifts in different
geographies for case processing support would follow the same SOPs
and receive ongoing upskilling through standardized training to
be able to harmonize shared tasks and ensure that there is reliable
consistency as tasks are handed over, while always delivering quality
and compliance.
Cultural differences and language barriers also are critical
considerations to navigate. Clients and service providers must
promote a sense of unity and shared purpose among teams that
might be scattered across the globe. Cultural sensitivity training and
Pharmaceutical Outsourcing | 18 | April/May/June 2024
Pharmaceutical Outsourcing Q2 2024

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