Sheffield Teaching Hospitals NHS Trust Clinical Research Office

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Sheffield Teaching Hospitals NHS Trust

Clinical Research Office

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1

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STH Industry Initiative



1.

Brief Introduction to Centre/Facility/Support Unit/Directorate/Team/Organisation


In line with targets set to retain the UK

life science industry and re
-
establish the NHS as a
world
-
class centre for clinical research and innovation, the CRO Sheffield implemented the
CRO Industry Initiative in January 2011.



2.

Services Provided/Activities undertaken


Aim: The initiative aims to

deliver an enhanced research profile (num
ber of studies and
study
income) for industry sponsored trials, via a joint Clinical Research Office and in partnership
with the SYCLRN by:



Provi
ding an outstanding service to i
ndustry and investigators



Developing
the reputation of Sheffield (CRO/SYCLRN) as a world
-
class environment
for undertaking industry sponsored research.



Establishing Sheffield (CRO/SYCLRN) as a preferred site for multi
-
centre clinical
research in partnership with industry.


Delivery Mechanism
s: The CRO Industry Team plans to achieve its aims by:



Delivery of a streamlined support function to expedite NHS permissions, time to
FPFV, recruitment
to time and target

and invoicing



Delivery of a business development function that will deliver of an
enhanced research
profile (number of studies and study income) for Industry sponsored trials.


Summary of work undertaken to date
: Appendix 1

summarise
s

the work undertaken by the
CRO Industry Team to date, the work still to be undertaken, and the resource
s required in
order for the Industry Initiative aims to be met in full.


3.

Organisational charts


See appendix 2


4.

Roles & Responsibilities


The CRO and SYCLRN have implemented a dedicated Industry Team to provide a service
tailored to the needs of Industry

and to deliver the objectives of the CRO Industry Initiative
.
The team comprises of:





Two dedicated Industry Research Coordinators, with an Industry background



A dedicated Industry Research Facilitator

(post under recruitment
; responsibilities yet to be

agreed
)



A dedicated Industry Manager (SYCLRN post)



An Industry Research Management Accountant


See appendix 2 for details


5.

Reporting lines and Accountability


See appendix 2









Sheffield Teaching Hospitals NHS Trust

Clinical Research Office

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Appendix 1: Summary of work undertaken to date


Table 1 Speed and
quality of feasibility

Work undertaken

Work still required

Resources and requirements


Implementation of processes
for:



I
dentification and targeting of
industry studies



R
apid turnaround of high
quality expressions of interest
to industry



Review and
agreement of
proposed recruitment targets


Outcome:

100% increase in the
number of expressions of interest
submitted to industry.


Implementation of
IT
systems
to:



A
llow rapid and accurate
determination of research
populations


Proposed outcomes:



E
nsure th
at STH can deliver
on promise



I
ncrease likelihood of repeat
business



Completion of
CReST
project to
:



C
reate clinical databases
required by Directorates



L
ink clinical databases to
the I2B2 data warehouse



Table 2 Speed and quality of contract
negotiation

Work undertaken

Work still required

Resources and requirements


Implementation of:



Implementation of a
dedicated Industry Research
Accountant



Adoption of the
principles of
the
NIHR Industry costing
template



Adoption of the ABPI model
agreements


Outcome:



Timeline for finance and
contracts review significantly
reduced



Costs allow ≥100%
recuperation of direct costs,
plus an additional 90% (70%
overhead and 20% capacity)
on staff time



Implementation of systems to:



A
utomate study costs



Full implementation of the
NIHR Industry Costing
Template



D
etermine the benefit/loss
ratio of
negotiating

the
sponsor budget i.e.

-

Increase in per patient
budget vs loss of income
from delay recruitment

-

Impact on repeat
business from STH
being seen as expe
nsive
and slow


Proposed outcomes:



Rapid study costing and
budget review



Massive reduction in study
set
-
up timelines



Increase in overall study
income


Resource and requirements:



Buy
-
in for centralised
costing



Implementation of
automated costing
systems



A
greed process and
criteria for conducting an
‘intelligent budget review’.








Table 3 Transparent pricing and income distribution

Sheffield Teaching Hospitals NHS Trust

Clinical Research Office

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Work undertaken

Work still required

Resources and requirements


Implementation of:



Transparent

breakdown of
direct/ indirect study costs
and research accounts to
whic
h income will be directed



Proposed Income Distribution
Model


Outcome:



Greater consistency and
predictability on costing for
Industry



Proposal of an income
distribution model for the
T
rust, for consultation with
Directorates.


Implementation of systems to:



Agreement of an

income
distribution model which
incentivises the Trust,
investigators and
Directorates.


Proposed outcomes:



Greater transparency of
income



Increased incentivisation
for
investigators and
Directorates



Use of industry income to
build research capacity and
capability

.



Resource and requirements:



Trust/UoS income
distribution model which
incentivises the Trust,
investigators and
Directorates.


Table 4 Speed and quality

of Research Governance approval

Work undertaken

Work still required

Resources and requirements


Implementation of processes for:



Master confidentiality agreements



Face to face

meeting with sponsor
and study team to review and
agree

-

recruitment targets

-

roles and responsibilities

-

support requirements

-

timelines



Adoption of NIHR streamlining
systems (CSP, model contracts)



Implementation of the Alfresco
document management system



Agreement to authorisation
processes for the new Research
management System
(RMS)



Review and benchmarking against
the Northwest Exemplar
Recommendations


Outcome:

Transparent and
streamlined Research Governance
approval process for both industry and
investigators


Implementation of systems
to:



Reduce the timeline for
cost collatio
n and
contract negotiation,
which are the rate
limiting f
actors for
almost all Research
G
overnance approvals.


Proposed outcomes:



H
uge reductions in the
Research Governance
approval times for STH



I
ncreased time for STH
investigators to recruit
patients to
studies



I
ncreased performance
of STH as a research
site



I
ncrease in repeat
business



I
ncreased research
opportunity for
investigators and
patients



I
ncrease in income to
the Trust


Resource and
requirements:



Buy
-
in from support
services for
centralised
costing



Implementation of
automated costing
systems



Agreed process and
criteria for conducting an
‘intelligent budget
review’.






Sheffield Teaching Hospitals NHS Trust

Clinical Research Office

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Table 5 Recruiting and invoicing to time and target

Work undertaken

Work still required

Resources and requirements


I
mplementation of processes
for:



Agreeing a realistic
recruitment target at study
set
-
up



Purchase by the CReST
Team of the EDG
-
E system
for recruitment tracking



M
anual invoicing systems
following receipt of visit
information from study teams.


Outcome:




Increase in income
recuperation


Implementation of systems to:



A
llow rapid and accurate
determination of research
populations

(both STH and
Primary Care)



Track study recruitment to
time and target



Automate invoicing, to allow
rapid transfer of information
and recovery of all industry
study related income.


Proposed outcomes:



E
nsure that STH can
deliver on promise



I
ncrease likelihood of
repeat business



Increased study income



Completion of
CReST
project to
:



Set
-
up clinical databases



Implement the EDGE
stu
dy tracking and
automated invoicing
systems


Buy
-
in from the PCRN and
SYCLRN



Explore the FARSITE
Primary Care data system




Table 6 Developing relationships

Work undertaken

Work still required

Resources and requirements


Introducing the Industry
Initiative to
:



Internal stakeholders



Key UoS

links



Research Networks /Priority
Groups


Pfizer Showcase set
-
up
:



Matching Pfizer and
STH/UoS experts



Regular follow
-
up meetings
with Pfizer Regional Medical
Manager


Attending national
NHS/Industry events



Implementation of systems to:



Collate and share
performance metrics



Continuing to monitor
internal stakeholder and
industry needs


Proposed outcomes:



Continue to meet the needs
of internal stakeholders



Continue to gain an industry
perspective



Completion of
CReST
project to
:



C
reate
systems to track
performance












Sheffield Teaching Hospitals NHS Trust

Clinical Research Office

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Table 7 Building capability and capacity

Work undertaken

Work still required

Resources and requirements


Provided research support
information and Identified the
training
needs of
:




Directorate Executives



Investigators



Research Nurses



Directorate Facilitators



Core Industry Team


Set
-
up of the New Investigator
Workshop



Implementation of systems to:



Promote, incentivise and
train new investigators.


Proposed outcomes:



Ensure capacity and
capability to allow uptake of
the pipeline of industry
research



Directorate buy
-
in to
promote research




Table 8 Communications

Work undertaken in Y1

Work still required

Resources and requirements




Development of
Industry the
CRO website



Promotion of

industry events
e.g. Pfizer Showcase




Development of an industry
communication strategy





Systems to identify and
report key
achievements































Sheffield Teaching Hospitals NHS Trust

Clinical Research Office

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Appendix 2: Organisational Chart



Clinical Research
Executive

Chair (Simon Heller)

Industry Lead

Research
Coordinator:

Tanya Loughran




Oversee delivery of
Industry Initiative




Ensure the CReST
(Clinical Research
Systems Team)
Informatics Program
delivers industry
requirements

R&D Director

(Simon Heller)

CRO Industry Team

Research
Coordinator:

Ramila Patel




Delivery of the Industry
Initiative within the
Neurosciences
Directorate




Implementation and
rollout of accrual tracking
system.

Research Facilitator
:

Post under
recruitment




Post under recruitment;
responsibilities yet to be
agreed

Research
Management
Accountant:

Ian Brown




Costing and cost negotiation



Invoicing & income distribution

SYCLRN Industry
Manager:

Liz Pryde




Delivery of SYCLRN high level
objectives for industry

SYCLRN Executive

Chair (George Kinghorn)

CRO Director

(Peter Sneddon)