Pharmaceutical Outsourcing Q2 2024 - 19

CLINICAL TRIALS
SECTION TITLE
language/translation support lessens misunderstandings and helps
promote effective teamwork.
Data security and compliance is another key consideration. Proven
measures and protocols must be in place to ensure that all regional
and country data protection regulations are consistently upheld
across geographic locations.
To help maintain consistent quality standards across all locations,
cross-team quality checks and review processes are needed to
ensure that work handed off from one team to another meets the
required standards. To this end, an around-the-clock monitoring
system also can track progress, identify bottlenecks, and address
any issues that arise. This proactive approach prevents delays and
keeps activity on track. It's also important to develop contingency
plans for potential delays or issues that may arise during the handoff
process. Backup resources or alternative solutions mitigates risks
and prevents disruptions.
Finally, a dedicated team of senior leaders for each region or team
provides oversight and orchestrates the handoff process to ensure
smooth transitions and address challenges promptly throughout the
FTS workflow.
Selecting an FSP Partner for FTS Solutions:
Key Considerations
In addition to having global resources, knowledge and systems in
place to facilitate best practices, several other key considerations
come into play when evaluating an FSP partner to implement an
FTS model. It's important to select an FSP partner with a track record
of delivering projects on time with quality and compliance. The FSP
partner's reputation may be evaluated through their longevity of
their experience providing FSP services, the longevity of their client
relationships, client references, and case studies.
Collaboration is also critical in a globally distributed environment.
Assess the FSP partner's ability to foster communication between
teams, regions, and with clients. Look for established communication
protocols, technological infrastructure, a strong culture of
collaboration, and, importantly, dedicated roles that are in place to
consistently drive implementation and ongoing communication.
For example, would the provider put a seasoned lead in place to act
as a single point of contact to coordinate the interactions between
different teams and departments globally and ensure the seamless
execution of project objectives? Responsibilities for this dedicated
lead role may include oversight of key performance indicators (KPIs),
finances, development and roll-out of governance, and system
integration coordination.
Another factor to consider is the breadth and depth of expertise
offered by the FSP partner, especially in any specific geographic
regions under consideration. Can the provider cover all the needs
of the engagement? Selecting a single FSP partner with expansive
therapeutic and functional expertise instead of engaging multiple
partners with different capabilities can streamline the outsourcing
process and facilitate more effective collaboration.
Tailored solutions also are critical when selecting an FSP partner.
Each project and client have unique needs and requirements. The
ideal provider should have established operations in global locations
to fully leverage a more flexible infrastructure and greater support
coupled with the ability to customize engagement models, systems,
and processes to address the specific challenges and goals of a
clinical development program. And they should have the capability
to quickly ramp up or down to accommodate fluctuating workloads.
Last, it is important to evaluate the FSP partner's recruitment and
training strategies. The quality of an FSP partner is only as good as
the quality of its team. Because skilled and experienced professionals
are in high demand-far surpassing supply-an FSP partner with
established global recruitment capabilities and an ongoing training
program is a necessity. Ensuring the provider has a pool of skilled
resources ready to be deployed for specific project needs is also
critical. For example, does the FSP partner have consistent processes
to vet personnel for written and spoken language competencies
and function-specific capabilities, regardless of location? Do they
have consistent training and onboarding processes in each location,
ensuring every team is comprised of highly qualified individuals who
can perform consistently across the board?
It is also important to engage in open discussions to address any
concerns or specific requirements, ensuring the development of a
strong partnership built on trust, transparency, and shared objectives.
Conclusion
As the biopharmaceutical industry faces growing competition,
coupled with increasing clinical development complexity, the
adoption of an FTS approach supported by the expertise of an
FSP partner has emerged as a powerful solution. By strategically
leveraging global teams across different time zones, drug
developers can unlock around-the-clock productivity, enhance
operational efficiency, and foster a collaborative work environment.
The successful implementation of FTS models requires careful
planning, clear communication, adherence to best practices, and
robust technology infrastructure. With a seasoned FSP partner by
their side, organizations can tap into global talent pools, optimize
resource allocation, and achieve remarkable advancements in clinical
development programs, making FTS solutions a game-changing
strategy to help meet ever-more challenging timelines, getting new
medications to patients faster.
References
1. Hardman TC, Aitchison R, Scaife R, Edwards J, Slater G. The future of clinical trials and drug
development: 2050. Drugs Context. 2023;12:2023-2-2. doi:10.7573/dic.2023-2-2
2. PPD Inc. The Pulse Report 2023. Accessed January 15, 2024. https://www.ppd.com/
pharmaceuticals-research-and-development
3. Markets & Markets. Functional Service Provider (FSP) services market - global forecast
to 2029.
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