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Functional
Service
Provider
What is a Functional
Service Provider or FSP?
Traditionally, functions such as monitoring would be retained in house with
permanent staff within a bio-pharmaceutical organisation. Alternatively, an
organisation may choose to outsource entire clinical studies (full service CRO).
The FSP model allows separation of core/non-core
capabilities within your company allowing you to choose
providers specialising in a discipline e.g. Clinical Monitoring,
Biostatistics, Orphan Drug or Oncology.
Clinical Professionals’ FSP model additionally allows you to
retain functional control, have confidence in staff retention,
lower cost and allow greater flexibility.
This removes the burden of employment and often reduces
day-to-day management requirements but has the benefits
of strategic control and direct integration within functions
of your business.
For me, it is knowing that I have the support
of the FSP team, not only in the recruitment
stages, but on an on-going basis, for the
duration of each assignment.
The need for FSP
FSP services offer benefits such as increased productivity, flexibility of
workforce and cost saving.There is also an ability to work real-time, a
distinct advantage over traditional full service CRO.Two examples are:
1. Scalability of workforce
Within an FSP, you are provided with dedicated resource to
utilise as you wish across therapeutic areas, studies and sites.
Resource requirements can change rapidly up or down, and
the FSP model is ideally suited to this. Should you quickly
need to upscale, we have the largest clinical staffing division
in Europe with over 50 dedicated sourcing specialists for
delivering FSP talent to find the staff you need.
When staff numbers need to be decreased, FSP models allow
clients to reduce resource simply and effectively without HR
or contract burdens.
2. Seamless Integration
Our FSP model will plug directly into your clinical trial
management system (CTMS) and other management
systems rather than the traditional CRO model, whereby they
transfer data at the conclusion of a trial.This allows you to
collaboratively review data with us in real time during a trial.
We also operate a comprehensive performance scorecard
to control quality and productivity levels, ensuring all the
monitoring is expedited as efficiently as possible.
CP FSP
TEAM
KPI
Measurements
Improving
Productivity
Funtional/Line
Management
Site Set Up
Leading GCP
Practise
Mentoring
Governance Training &
Development
Critical Success Factors
There are a number of indicators for critical success, such
as cultural fit, proven functional expertise plus relative size
and capabilities of the FSP in comparison to the sponsor’s
needs. A sponsor should choose an FSP based on these
factors, and should relate to the FSP’s existing client profile
as this helps ensure good service levels and FSP attention.
Background
Since 2006 Clinical Professionals have been experts in
delivering FSP projects to our partners. Our focus is on
speciality teams of under 100 people.With traditional CRO’s
focusing on very large global teams our customers wanted
bespoke and cost effective solutions seamlessly integrating
into their management structure, with a provider who valued
their small scale FSP requirements, understanding the need
for specialisation.
Scope
We focus on teams from 2 – 100 people, often with highly
specialist requirements such as Orphan Drug, Oncology,
Ophthalmology and Medical Devices.
Capability
We have a track record of running International FSP teams
supported by additional resources where appropriate.We
are not a full service CRO but instead our FSP model has
the capabilities to deliver a specialist, flexible, targeted and
efficient solution without the high costs associated with
traditional CRO services.
Coverage
With teams based in over 15 countries our expanding network
is designed to meet the needs of our International clients.
Staff Retention
With staff turnover in traditional CRO’s in excess of 25% we
have a track record on working to within 10%. Giving our
customers knowledge that they have consistency that there
specialisation requires.
Clinical Professionals offers CRO services geared
purely for delivering best in class FSP teams.
CP FSP
PARTNERSHIP
Speed Expertise
Partnership
Talent
Flexibility
Quality
Cost
Clinical Professionals
FSP staff retention vs.
70% industry average
Integration
It is often perceived by Study teams that an outsourced partner will create
more work. In fact, with a small amount of internal business process
engineering, you will have one point of contact to streamline the process.
The Sponsor’s study teams would design the
protocol and then leave the resourcing and process
management to the Clinical Professionals team who
in turn can provide continuous updates and real-time
data. Supported by our performance scorecard, this
creates a powerful service and partnership.
The reason for introducing an FSP model is often driven by
time and workforce efficiencies rather than by cost. However,
these efficiencies create immediate cost savings such as
the workforce being of the appropriate strength versus the
workload required.
The more significant but indirect cost saving is the time
efficiencies which means it is possible to get a drug to
market sooner.
Since moving to the FSP, recruitment has
definitely become an easier task.The whole
process is now structured in such a way that
it has saved me time and energy and the
company money in recruiting new staff.
Cost saving up to Time saving up to
• 50% reduction in the amount of time required during the
recruitment process for new staff coming into the FSP.
• Within 24 hours of a resource request being received,
Clinical Professionals have provided a high standard of
candidates to be considered for the FSP.
• The added service levels as part of that FSP has enabled
that client line managers more time to focus on their own
role, due to the support via Clinical Professionals to manage
the FSP team members.
To arrange a meeting to assess how Clinical Professionals
can work for you please contact us.
*Independent Market Research conducted by loyalty chain 2013.
Value
The reason for introducing an FSP model is often driven by
the desire to create efficiencies within the resourcing and
conduct of studies, without compromising on quality.
As well as providing value regarding recruitment and
management of quality staff into your team via the FSP,
the collaboration between client and FSP partner can bring
further value by reviewing items such as processes and
training, to create further efficiencies in the way the team is
managed to increase productivity.
The more significant but indirect cost saving relating to the
efficiencies generated via an FSP is the reduced cycle time
enabling clients to get drugs to market sooner and in a more
cost efficient manner.
Governance
It is imperative that the partnerships forged between the
sponsor and Clinical Professionals is managed appropriately,
and governance forms a crucial part of the relationship.
Our Governance meetings are held at least bi-annually in
order to review the current status of the FSP service, discuss
areas of success and identify areas of improvement, plus
the shared vision for the future of the relationship. Our FSP
model continues to evolve throughout the lifecycle of the
partnership, and governance enables this.
Key Performance Indicators (KPIs) agreed by both parties at
the beginning of the relationship are pivotal to measuring the
performance of the relationship on an on-going basis, and
review of these forms a large part of the governance meetings.
Case Study
A current partnership in a specialist
department of a top 10 pharmaceutical
organisation achieved:
Contact:
fsp@clinicalprofessionals.eu
UK Office:
3RD floor
33 Blagrave Street
Reading
RG1 1PW
Tel: +44(0)118 959 4990
www.clinicalprofessionals.co.uk
EU Office:
Ground floor
11-12 Bouverie Street
London
EC4Y 8DP
Tel: +44(0)207 822 1710
www.clinicalprofessionals.eu
German Office:
Königstrasse 10C
Stuttgart
70173
Germany
Tel: +49(0)711 2225 4403
www.clinicalprofessionals.de
Time to hire
reduced by:
Cost reduction
in year 1.
of clients rate clinical
professionals as their
‘most trusted partner’.*

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What is a Functional Service Provider (FSP) and how can it benefit clinical trials

  • 2. What is a Functional Service Provider or FSP? Traditionally, functions such as monitoring would be retained in house with permanent staff within a bio-pharmaceutical organisation. Alternatively, an organisation may choose to outsource entire clinical studies (full service CRO). The FSP model allows separation of core/non-core capabilities within your company allowing you to choose providers specialising in a discipline e.g. Clinical Monitoring, Biostatistics, Orphan Drug or Oncology. Clinical Professionals’ FSP model additionally allows you to retain functional control, have confidence in staff retention, lower cost and allow greater flexibility. This removes the burden of employment and often reduces day-to-day management requirements but has the benefits of strategic control and direct integration within functions of your business. For me, it is knowing that I have the support of the FSP team, not only in the recruitment stages, but on an on-going basis, for the duration of each assignment.
  • 3. The need for FSP FSP services offer benefits such as increased productivity, flexibility of workforce and cost saving.There is also an ability to work real-time, a distinct advantage over traditional full service CRO.Two examples are: 1. Scalability of workforce Within an FSP, you are provided with dedicated resource to utilise as you wish across therapeutic areas, studies and sites. Resource requirements can change rapidly up or down, and the FSP model is ideally suited to this. Should you quickly need to upscale, we have the largest clinical staffing division in Europe with over 50 dedicated sourcing specialists for delivering FSP talent to find the staff you need. When staff numbers need to be decreased, FSP models allow clients to reduce resource simply and effectively without HR or contract burdens. 2. Seamless Integration Our FSP model will plug directly into your clinical trial management system (CTMS) and other management systems rather than the traditional CRO model, whereby they transfer data at the conclusion of a trial.This allows you to collaboratively review data with us in real time during a trial. We also operate a comprehensive performance scorecard to control quality and productivity levels, ensuring all the monitoring is expedited as efficiently as possible. CP FSP TEAM KPI Measurements Improving Productivity Funtional/Line Management Site Set Up Leading GCP Practise Mentoring Governance Training & Development
  • 4. Critical Success Factors There are a number of indicators for critical success, such as cultural fit, proven functional expertise plus relative size and capabilities of the FSP in comparison to the sponsor’s needs. A sponsor should choose an FSP based on these factors, and should relate to the FSP’s existing client profile as this helps ensure good service levels and FSP attention. Background Since 2006 Clinical Professionals have been experts in delivering FSP projects to our partners. Our focus is on speciality teams of under 100 people.With traditional CRO’s focusing on very large global teams our customers wanted bespoke and cost effective solutions seamlessly integrating into their management structure, with a provider who valued their small scale FSP requirements, understanding the need for specialisation. Scope We focus on teams from 2 – 100 people, often with highly specialist requirements such as Orphan Drug, Oncology, Ophthalmology and Medical Devices. Capability We have a track record of running International FSP teams supported by additional resources where appropriate.We are not a full service CRO but instead our FSP model has the capabilities to deliver a specialist, flexible, targeted and efficient solution without the high costs associated with traditional CRO services. Coverage With teams based in over 15 countries our expanding network is designed to meet the needs of our International clients. Staff Retention With staff turnover in traditional CRO’s in excess of 25% we have a track record on working to within 10%. Giving our customers knowledge that they have consistency that there specialisation requires. Clinical Professionals offers CRO services geared purely for delivering best in class FSP teams. CP FSP PARTNERSHIP Speed Expertise Partnership Talent Flexibility Quality Cost Clinical Professionals FSP staff retention vs. 70% industry average
  • 5. Integration It is often perceived by Study teams that an outsourced partner will create more work. In fact, with a small amount of internal business process engineering, you will have one point of contact to streamline the process. The Sponsor’s study teams would design the protocol and then leave the resourcing and process management to the Clinical Professionals team who in turn can provide continuous updates and real-time data. Supported by our performance scorecard, this creates a powerful service and partnership. The reason for introducing an FSP model is often driven by time and workforce efficiencies rather than by cost. However, these efficiencies create immediate cost savings such as the workforce being of the appropriate strength versus the workload required. The more significant but indirect cost saving is the time efficiencies which means it is possible to get a drug to market sooner. Since moving to the FSP, recruitment has definitely become an easier task.The whole process is now structured in such a way that it has saved me time and energy and the company money in recruiting new staff. Cost saving up to Time saving up to
  • 6. • 50% reduction in the amount of time required during the recruitment process for new staff coming into the FSP. • Within 24 hours of a resource request being received, Clinical Professionals have provided a high standard of candidates to be considered for the FSP. • The added service levels as part of that FSP has enabled that client line managers more time to focus on their own role, due to the support via Clinical Professionals to manage the FSP team members. To arrange a meeting to assess how Clinical Professionals can work for you please contact us. *Independent Market Research conducted by loyalty chain 2013. Value The reason for introducing an FSP model is often driven by the desire to create efficiencies within the resourcing and conduct of studies, without compromising on quality. As well as providing value regarding recruitment and management of quality staff into your team via the FSP, the collaboration between client and FSP partner can bring further value by reviewing items such as processes and training, to create further efficiencies in the way the team is managed to increase productivity. The more significant but indirect cost saving relating to the efficiencies generated via an FSP is the reduced cycle time enabling clients to get drugs to market sooner and in a more cost efficient manner. Governance It is imperative that the partnerships forged between the sponsor and Clinical Professionals is managed appropriately, and governance forms a crucial part of the relationship. Our Governance meetings are held at least bi-annually in order to review the current status of the FSP service, discuss areas of success and identify areas of improvement, plus the shared vision for the future of the relationship. Our FSP model continues to evolve throughout the lifecycle of the partnership, and governance enables this. Key Performance Indicators (KPIs) agreed by both parties at the beginning of the relationship are pivotal to measuring the performance of the relationship on an on-going basis, and review of these forms a large part of the governance meetings. Case Study A current partnership in a specialist department of a top 10 pharmaceutical organisation achieved: Contact: fsp@clinicalprofessionals.eu UK Office: 3RD floor 33 Blagrave Street Reading RG1 1PW Tel: +44(0)118 959 4990 www.clinicalprofessionals.co.uk EU Office: Ground floor 11-12 Bouverie Street London EC4Y 8DP Tel: +44(0)207 822 1710 www.clinicalprofessionals.eu German Office: Königstrasse 10C Stuttgart 70173 Germany Tel: +49(0)711 2225 4403 www.clinicalprofessionals.de Time to hire reduced by: Cost reduction in year 1. of clients rate clinical professionals as their ‘most trusted partner’.*