Supporting multiple eDC systems – the CRO dilemma Rob Nichols, Quintiles GDRU Director of Data Operations and Business Solutions CCRA @ UKTI 01NOV05.

Supporting multiple eDC Supporting multiple eDC systems – the CRO systems – the CRO dilemmadilemma

Rob Nichols, Quintiles GDRURob Nichols, Quintiles GDRUDirector of Data Operations and Director of Data Operations and

Business SolutionsBusiness Solutions

CCRA @ UKTI 01NOV05CCRA @ UKTI 01NOV05

OutlineOutline

eDC - desirable or realityeDC - desirable or reality Outline of the potential problemsOutline of the potential problems How can these issues be managedHow can these issues be managed

1. Adapt to multiple systems1. Adapt to multiple systems

2. Drive forward in-house solution2. Drive forward in-house solution ConclusionConclusion

eDC – DefinitioneDC – Definition

An electronic system (eCRF) to directly capture An electronic system (eCRF) to directly capture data historically captured via traditional paper data historically captured via traditional paper CRFs (note however that remote data entry is CRFs (note however that remote data entry is still used in 9/10 ‘eDC’ studies)still used in 9/10 ‘eDC’ studies)

An extension takes this to capturing data An extension takes this to capturing data direct from devices (e.g. BP & ECG), merging direct from devices (e.g. BP & ECG), merging in external data (e.g. laboratory data), using in external data (e.g. laboratory data), using barcodes to capture subject’s id, nurses id, barcodes to capture subject’s id, nurses id, sample times and dates (the 3-way swipe)sample times and dates (the 3-way swipe)

eDC Trial Uptake - desirableeDC Trial Uptake - desirable

The benefits of The benefits of Full engagement for all in clinical process with Full engagement for all in clinical process with

data availability in real timedata availability in real time Quicker lock / reportQuicker lock / report Lower direct costs (over 30 subject trial)Lower direct costs (over 30 subject trial) Lower indirect costs (quicker to market / Lower indirect costs (quicker to market /

quicker to kill)quicker to kill)

are leading to the push towards eDC replacing are leading to the push towards eDC replacing paper solutionspaper solutions

eDC Trial Uptake – the dreameDC Trial Uptake – the dream

Hypothetical indirect savings for big pharma Hypothetical indirect savings for big pharma with integrated protocol (4 parts)with integrated protocol (4 parts)

1 week delay for significant new product = £19.2M*Saving per part from LPO to Lock = up to 3 weeksTotal saving = 12 weeks=£229M=$447M

Smaller companies benefit from a quicker sell / investment = improved cash flow

* Source UKTI and CCRA survey on UK CRO industry* Source UKTI and CCRA survey on UK CRO industry

eDC Trial Uptake - realityeDC Trial Uptake - reality

2001 2002 2003 2004 2005 2006

Phase I trialsPhase II trialsPhase III trialsPhase IV trials

20,000

Number

of Web

trial

starts

10,000

eDC Trial Starts 2001 2002 2003 2004* 2005* 2006*

Phase I Trials 126 261 514 934 1,510 2,141Phase II Trials 651 1,320 2,508 4,313 6,532 8,771Phase III Trials 387 802 1,581 2,871 4,642 6,584Phase IV Trials 20 43 86 164 282 427Total eDC Trials 1,184 2,425 4,690 8,282 12,966 17,863eDC Trial Starts as Percentage of Total Trial Starts 4% 8% 14% 24% 35% 46%

Source: Forrester Research, Inc.

eDC Trial Uptake - realityeDC Trial Uptake - reality

Centre watch (03) estimated around 40% in Centre watch (03) estimated around 40% in 2004 would use eDC2004 would use eDC

CDISC (04 survey) – 30% of responders trials CDISC (04 survey) – 30% of responders trials were using eDCwere using eDC

OutlineOutline




Phase I - DefinitionPhase I - Definition

Will vary but here built around:Will vary but here built around: A dedicated Phase I/IIa clinical unitA dedicated Phase I/IIa clinical unit Majority of work is first in manMajority of work is first in man 75 beds in 4 wards75 beds in 4 wards 60 protocols per year60 protocols per year CROCRO

Content of presentation should though be widely Content of presentation should though be widely applicableapplicable

Clinical eDC experienceClinical eDC experience Quintiles GDRU has been running sponsor-driven Quintiles GDRU has been running sponsor-driven

Phase I eDC studies for around 6 years (30+ to Phase I eDC studies for around 6 years (30+ to date)date)

Partnered a pharmaceutical industry leader as they Partnered a pharmaceutical industry leader as they have developed and delivered 3 eDC systemshave developed and delivered 3 eDC systems

Have developed our own eDC solution (ePhase I Have developed our own eDC solution (ePhase I Lite) with around 15 studies won over the last 9 Lite) with around 15 studies won over the last 9 monthsmonths

Current clinical positionCurrent clinical position

Staff enjoy using eDC and clinically it works wellStaff enjoy using eDC and clinically it works well

How to escalate and meet future demandHow to escalate and meet future demand

Differing Systems – the CRO DilemmaDiffering Systems – the CRO Dilemma

Pharma want to commit to one approachPharma want to commit to one approach Pharma companies work with CROPharma companies work with CRO CRO have multiple systems dilemma…CRO have multiple systems dilemma…

An extreme example is a CRO phase I clinical An extreme example is a CRO phase I clinical unit (also an issue for clinical units working on unit (also an issue for clinical units working on multiple phase III studies)multiple phase III studies)


There are currently an estimated 200 different There are currently an estimated 200 different suppliers of ‘eDC’ solutionssuppliers of ‘eDC’ solutions

This has chaotic implications for a CRO This has chaotic implications for a CRO working with 40 different sponsors a year if working with 40 different sponsors a year if each sponsor arrives with a different eDC each sponsor arrives with a different eDC solutionsolution


TrainingTraining Staff require in-depth familiarity with multiple Staff require in-depth familiarity with multiple

types of software (all [~70] clinical staff are types of software (all [~70] clinical staff are trained in all systems)trained in all systems)

½ - 5 days per system for generic training and ½ - 5 days per system for generic training and also study specific trainingalso study specific training


LogisticsLogistics Ever increasing number of passwords to be Ever increasing number of passwords to be

remembered (and ~$200 a reset!)remembered (and ~$200 a reset!)

User SupportUser Support Need to be familiar with the contact details and Need to be familiar with the contact details and

working processes for several external working processes for several external helpdeskshelpdesks


ResourceResource Where remote data entry is used data entry Where remote data entry is used data entry

support required (clinical, secretarial/admin, support required (clinical, secretarial/admin, temporary staff?)temporary staff?)

Role of project manager can cross over with Role of project manager can cross over with traditional data manager rolestraditional data manager roles

Depending on technology local involvement of Depending on technology local involvement of IT IT


ITIT Regulatory compliance of systemsRegulatory compliance of systems Security may be an issue if sponsors place Security may be an issue if sponsors place

their infrastructure (e.g. server, network, PCs) their infrastructure (e.g. server, network, PCs) into the clinical unitinto the clinical unit

Interaction with current systems (cardiac Interaction with current systems (cardiac monitoring)monitoring)

Regular access for sponsor staff may be Regular access for sponsor staff may be requiredrequired

Space may be an issue with new servers, Space may be an issue with new servers, networks, and 15+ collection devices per networks, and 15+ collection devices per projectproject

OutlineOutline




Differing Systems – the CRO solutionDiffering Systems – the CRO solution

Current strategy Current strategy Two pronged approachTwo pronged approach

1 – support ‘numerous’ sponsor driven solutions 1 – support ‘numerous’ sponsor driven solutions

2 – develop an in-house solution2 – develop an in-house solution

OutlineOutline




Support sponsor driven solutionsSupport sponsor driven solutions

++ The industry will move towards fewer standard The industry will move towards fewer standard eDC software solutions (as with SASeDC software solutions (as with SAS®®, Clintrial, Clintrial®®, , Oracle ClinicalOracle Clinical®®))

0%

25%

50%

75%

100%

2001 2003

Top Five Next Five Rest of Market


++ Will tend to be driven by bigger companies Will tend to be driven by bigger companies who can bring multiple studies, allowing who can bring multiple studies, allowing learning curve (training, new procedures) to be learning curve (training, new procedures) to be reusedreused

++ Data collection part of software is Data collection part of software is standardisingstandardising

- Systems may now all look very similar but way Systems may now all look very similar but way sponsors are using them still tend to differ sponsors are using them still tend to differ (even same software used in different ways)(even same software used in different ways)


- - May put a lot of resource into educating the May put a lot of resource into educating the sponsor, and vendor (knowledge transfer)sponsor, and vendor (knowledge transfer)

++ Internet based solutions will help address the Internet based solutions will help address the space required as can run all systems off same space required as can run all systems off same hardwarehardware

++ Increased acceptance of eSource Increased acceptance of eSource

+ + Biometric passwordsBiometric passwords


PortalsPortals

Develop central interface through which both Develop central interface through which both CRO and sponsor can access multiple products CRO and sponsor can access multiple products and studiesand studies

One password per userOne password per user Access restrictedAccess restricted Easier management of multiple eDC systemsEasier management of multiple eDC systems


Potential support availablePotential support available House serverHouse server Supply/support network/hardwareSupply/support network/hardware Database build for non supported softwareDatabase build for non supported software eSource or paper source (remote data entry)eSource or paper source (remote data entry) Staff available for training Staff available for training Query managementQuery management Query resolutionQuery resolution? Data management? Data management Backend services (data conversion, SAS, Backend services (data conversion, SAS,

statistics, medical writing)statistics, medical writing)


StrategyStrategy

Manage the sponsors expectations. Put in place Manage the sponsors expectations. Put in place an internal implementation team who focus the an internal implementation team who focus the sponsors on standardising where possible.sponsors on standardising where possible.

Input into eCRF designInput into eCRF design Use CRO infrastructureUse CRO infrastructure Training – timing (inc for shift staff) and contentTraining – timing (inc for shift staff) and content Query managementQuery management

OutlineOutline




In-house eDC solution - remitIn-house eDC solution - remit

Processes to fit the rapid and flexible Phase I Processes to fit the rapid and flexible Phase I (not Phase III) environment(not Phase III) environment

Direct data capture at bedsideDirect data capture at bedside High quality data collected in real timeHigh quality data collected in real time Secure, on demand, online access to data for Secure, on demand, online access to data for

all role playersall role players Set-up times that do not impact on clinical Set-up times that do not impact on clinical

startstart Timelines ‘dramatically’ reduced after last-Timelines ‘dramatically’ reduced after last-

patient-outpatient-out

In-house eDC solutionIn-house eDC solution

We went forWe went for Database and edit checks on a central server, Database and edit checks on a central server,

use internet browser to connect to server via use internet browser to connect to server via tablet PCs and a wireless networktablet PCs and a wireless network

PhaseForward’s InFormPhaseForward’s InFormtmtm

An Industry Leader in eDC technologyAn Industry Leader in eDC technology But processes are software independentBut processes are software independent

Develop in-house solutionDevelop in-house solution

+ + Will be utilized by smaller/medium sponsors who Will be utilized by smaller/medium sponsors who will not have own solutionwill not have own solution

+ + Efficiencies of scale bring down price (less than Efficiencies of scale bring down price (less than paper) and setup timelines (match MHRA)paper) and setup timelines (match MHRA)

++ Processes will be repeated on each study Processes will be repeated on each study ensuring high quality levels from staff very ensuring high quality levels from staff very familiar with systemfamiliar with system

-- Can we motivate bigger companies to adopt Can we motivate bigger companies to adopt

Develop in-house solutionDevelop in-house solution

StrategyStrategyMotivate sponsors to take in-house solution. Motivate sponsors to take in-house solution. HowHowKey requirement for most sponsors is how final Key requirement for most sponsors is how final

delivered data look (CDISC or sponsor format), delivered data look (CDISC or sponsor format), not behind the scene processes. not behind the scene processes.

=> Get all benefits of eDC with focus on saving of => Get all benefits of eDC with focus on saving of several weeks from LPO to report, data in several weeks from LPO to report, data in required format and lower costs… required format and lower costs…

OutlineOutline




ConclusionConclusion

In-house solution will be utilized by the In-house solution will be utilized by the majority of sponsors.majority of sponsors.

A flexible approach to those sponsors who A flexible approach to those sponsors who wish to implement their own solutions - while wish to implement their own solutions - while trying to develop a level of standardisation in trying to develop a level of standardisation in approach across different systems/sponsors.approach across different systems/sponsors.

With the increasing number of preferred With the increasing number of preferred agreements, hybrids may well develop – i.e. agreements, hybrids may well develop – i.e. sponsor specific in-house solutions (or in-sponsor specific in-house solutions (or in-house sponsor specific solution).house sponsor specific solution).

© Quintiles Limited 2005

[email protected]

eDC solution – which softwareeDC solution – which software

Still a very large number of potential vendors with Still a very large number of potential vendors with fragile existences. Assess what will work best in fragile existences. Assess what will work best in local environment.local environment.

Long term stabilityLong term stability Still riding the Dot-com vision of fast profit, Still riding the Dot-com vision of fast profit,

short durationshort duration Consolidation, acquisition, bankruptcy of eDC Consolidation, acquisition, bankruptcy of eDC

vendorsvendors

A partner to grow with youA partner to grow with you

eDC solution – which softwareeDC solution – which software

Current customer baseCurrent customer base Previous experience – total trialsPrevious experience – total trials Check regulatory complianceCheck regulatory compliance Front ends are harmonising but unreliable Front ends are harmonising but unreliable

products still existproducts still exist Different functionality, export/reporting tools, Different functionality, export/reporting tools,

approaches to pricingapproaches to pricing

Supporting multiple eDC systems – the CRO dilemma Rob Nichols, Quintiles GDRU Director of Data Operations and Business Solutions CCRA @ UKTI 01NOV05.

Documents

edc slide

edc studies

multiple edc systems

edc definition

different edc solution

cro cro

edc cdisc

outline edc desirable