the journey toward paperless clinical trials

The Journey Toward Paperless Clinical Trials

Copyright © 2009 Honeycomb Xtalks Inc.

Gail M. Farfel, Ph.D., President, Pharmaceutical & Regulatory Strategy, GM Group Consulting

Alison Shurell, Vice President, Life Sciences Product Marketing, IntraLinks

Featured Speakers:


www.xtalks.com www.intralinks.com


Gail M. Farfel, Ph.D., President, Pharmaceutical & Regulatory Strategy, GM Group Consulting

Gail M. Farfel, Ph.D. is a consultant to pharmaceutical and allied industry companies, advising clients with all aspects of pharmaceutical development and registration: clinical development planning and regulatory strategy, protocol design and study start up, clinical operations, Advisory Boards and FDA Advisory Committees. She has 18 years experience in US and global pharmaceutical development and marketing, including 11 years at Pfizer and 2 yrs as VP, Therapeutic Head, Neuroscience at Novartis. Dr. Farfel is familiar with all aspects of clinical trial design and start-up, having started as a Project Clinician at Pfizer, and worked on teams conducting research both in-house and using a CRO model. She has used and helped design remote data entry systems, web-based clinical study interfaces and document sharing workspaces since the early 1990's, and was a member of PhRMA'sClinical Trials Working Group.



Alison Shurell, Vice President, Life Sciences Product Marketing, IntraLinks

Alison Shurell is vice president of Life Sciences Product Marketing. She is responsible for building on IntraLinks position as the leading software as a service solution for critical information exchange in the Life Sciences industry. In this role, she works closely with industry leaders in pharmaceutical, biopharma and medical device companies, as well as investigative sites, IRBs/ECs and other members of the Life Sciences community to understand market trends, problems industry drivers to impact product strategy and direction at IntraLinks. Shurell’s background includes more than 15 years of experience in corporate marketing roles in the B2B software and financial services markets. She holds an undergraduate degree from Miami University and an MBA from Baldwin-Wallace College.


A clinical user perspective

Gail M. Farfel PhDG Meredith Consulting, LLCNovember 5, 2009

Prehistoric Remote Data Entry Systems

Study Start-up docs not included

N.B., email was not ubiquitous in business in the early 1990’s

Benefit of rapid study close-out not yet permeated through institutions

6Farfel Paperless Trials Nov. 5, 2009

Instant or nearly instantmessaging

document exchange

document retrieval

Telecommunication, videoconferencing, Skype

Team collaboration software and online access mean colleagues no longer need to be co-located

PDAs, iPhone now reliably open files from Office Applications

Netbooks fill the existing gap


FDA supports technology solutions to improve clinical trial efficiency

Critical Path InitiativeeSourcing (capturing clinical data electronically at the source)Fully electronic submissions

EMEA mandates eCTD format for electronic filing beginning Jan 1, 2010

Farfel Paperless Trials Nov. 5, 2009 8

• Most companies use a hybrid of computer-based applications and paper to set up, run and report clinical trials

• EDC widely computerized, but most companies use worksheets to capture data and have study coordinators enter into EDC system

• Janssen/Medidate eSourcing pilot

• Study start-up is often online– Web-based and proprietary systems

– e-Forms vs uploading e-documents

• Queries are often email or via proprietary CTMS mail


Electronic Data Capture (EDC)◦ “Efficient and effective EDC is 30 percent programming and 70

percent process” – Pozzo & DeVries

◦ CDISC and HL7 standards

◦ ePRO

Medical tests and Phase I studies◦ centralized EKGs, labs, heart monitor shirts

IVRS/IWRS

Query handling

Grant payment


What is End-to-End:

Discovery to Medical Care?

Development through New Drug Application?

Are there natural, and un-natural, integrations?

Software solutions, Software-as-a-Service

Software plus consulting services

Best of breed vs All-in-One


If the Jetsons were in the drug development business, what would it look like?

Is there a preferred solution format?

FDA’s Critical Path Initiative


As quality increases, edit checks decrease

Less monitor travel: only start-up, close-out and audits are performed on site

Difficulty adopting eSourcing (source data directly to eCRF)◦ some success with HR monitoring

requires excruciating compliance with 21CFR Part 11

Security and durability of on-site computers an issue, as is reliability of back-up system


• Drug Discovery Software• Site Feasibility and Study start-up exchanges• Interactive Voice/Web Response Systems• Electronic Data Capture• Data and Document Repositories• Pharmacovigilance and Safety Reporting• Regulatory Repositories• Electronic Health Records• Disease Management Systems


Seamless synchronization of trial-site data with a central data management system

Availability of data at all times in both directions, from the site to the center data-management server and back from the server to the site

ability to pull data from different systems to integrate and populate reports, both standard and customized

e Signature


Estimated cost of maintaining paper archives: $1.25/pg

The benefits of paperless trials outweigh the difficulties

Barriers to seamless, fully paperless trials include state of the technology, particularly eSource

financial investment in current solutions which may not integrate with new solutions

large effort to get enterprise-wide adoption of new applications

Most companies’ vision of the future includes paperless trials


1. Bleicher P., The Fully Electronic Office (or Clinical Trial) Myth, http://license.icopyright.net/user/viewFreeUse.act?fuid=NTQ0MDUwNQ%3D%3D, Oct 1, 2004.

2. CenterWatch US Investigative Site Survey 2007, www.centerwatch.com3. Lownie K., In Search of Paperless Clinical Trials, Infonomics Magazine,

http://www.aiim.org/infonomics/in-search-paperless-clinical-trials.aspx, July/Aug 2009.

4. Pozzo & DeVries, Paperless Progress, Applied Clinical Trials Online, http://license.icopyright.net/user/viewFreeUse.act?fuid=NTQzOTQwMA%3D%3D, Oct 1, 2005.

5. Schell D., The Evolving Role of Pharmacovigilance, Life Science Leader, Oct 2009 pp.44-47


Gail M. Farfel, PhDG Meredith Consulting, LLC

email: [email protected]: 201.485.5101


The Journey TowardsPaperless Clinical Trials

Alison Shurell – VP, IntraLinks Life Sciences Product MarketingNOVEMBER 5, 2009

The Move Towards Web-based Solutions

TrendShift to cloud computing

Industry is looking for ways to reduce cost; getting value sooner, using operational budget versus capital expenditureIndustry is actively adopting e-solutions for clinical trial management

Move to streamline processes & leverage business intelligence

Market leaders are interpreting the regulations differently now to allow for paperless SOPs while capitalizing on process intelligence

Drive towards global, centralized solutions

More decisions are being made for global solutions (based on recent RFPs)Looking to reduce the number of systems required for clinical studies

Interest in “community”

Desire to reach unknown sites (sponsors), studies (sites) and patients (both)Desire for a “common place” for all clinical trial participants – the “portal”

* Based on direct market feedback from 15-20 companies (~45 individuals) in the US and EMEA over the past seven months.

Why Web-Based Portals?

SAVES TIME Web-based solutions available 24/7/365Instant document distribution & submissionEasy version control and information accessSpeeds study start-up process – faster site activationAllows online monitor review prior to visitDashboard view of status, to-dos, calendar, etc.Maintained and supported by the vendor, so no burden to IT

SAVES MONEY

No more paper processing, overnight mail, FTE time, etc.Web-based, so no more laptopsShorten trial duration — reduced monitor, advertising, CRO costsSpeed time-to-market — beat competitors, enjoy longer patent protection time

ADDS SECURITY AND CONTROL

Document locking and protectionVaried user access privilegesAbility to instantly add/remove users from the portalDetailed record of all portal activity21 CFR Part 11 Compliance

Improving Operational Speed & Efficiency

Activity Old Way New WayIdentify Target Sites

Distribute & Collect Feasibility and/or Interest Survey

Site Start-up

• Search internal database• Engage commercial site

database services• Phone, email, fax

• Engage site recruitment services• Copy/collate the Feasibility

Survey and/or Interest Survey and send to all target sites

• Follow-up phone calls

• Manage contract negotiation, regulatory documents, IRB approval via courier, fax and email

• Patient recruitment & marketing materials sent out via courier

• Follow-up phone calls

• “Market” research to the community• Browse community to identify sites & patients in

tandem• Hone search by specific study criteriaBenefit: Higher quality target sites

• Feasibility Survey and/or Interest Survey eForms pre-populated with known data

• Distribute Feasibility Survey and/or Interest Surveys at once to all target sites electronically

• Track status of each target site responseBenefit: Accurate & reusable information

collected

• Electronic distribution and collection of contract, regulatory documents and IRB approval

• Track document completion status of each site• Maintain a central repository of all study

documentsBenefit: Get to first site, first patient visit faster

Sponsors have limited access to sites and target patients — many sites and patients are unknown; those that are known are saturated

Site Recruitment Today

Clinical Research Site Registry

Sites Self Registered

Sites IntraLinks Invited

Sites You Invited

• Investigators can "Opt In" to the Clinical Research Network• Create a profile to promote their experience, research interest and facilities• Make connections to Sponsors

Site Recruitment

1

Sponsor Searches Site

Registry

IntraLinks returns list of Sites

meeting Sponsor search criteria

2

Sponsor selects sites to send

interest survey

3

Interested

Not Interested

Not Accessed

email notification

email

notifica

tion

email notification

4

5

Clinical Study Management (Start-up through Close-out)

1

Sponsor distributes essential Reg docs

Sponsor request Reg Doc Completion

from Sites

2

IRB receives review request

IRB s/ ECs

4 email notification

5 IRB post approval. Site and Sponsor receive

alert.

Fully Completed(1572, CV, Med

Lic. FD, etc)

Partially Completed(1572, CV)

Not Accessed

email notification

email

notifica

tion

email notification

3

6

Improving Speed and ComplianceActivity Old Way New WaySAE/SUSAR received from Investigative Site

Distribute Safety Letters to all affected Investigative Sites

Tracking and Reporting

• Reported to sponsor via phone, email or fax

• Query the site for additional information via phone, email or fax

• Classify event• Complete safety report

• Time-consuming process of creating and mailing out safety letters to sites, IRBs/ethics committees

• Lack of security around distribution

• Lack of receipt confirmation• Lack of insight into which sites

have reviewed the safety information

• Receive SAE/SUSAR online immediately and securely

• Receive supplemental information online immediately and securely

• Simultaneous online review of informationBenefit: Faster, more secure SAE/SUSAR intake

• Electronic distribution of reports to sites, IRBs/ethics committees in one step

• Safety documents are immediately available to sites around the globe

• Email or pager alert sent to notify investigator of safety document posted for review

Benefit: Central, secure standardized method for faster safety document distribution

• Maintain a record of what was distributed, when, and to whom for regulatory compliance

• Track document access• Maintain a central repository of all safety

documentsBenefit: Record of safety document distribution

established for regulatory compliance

Safety Information Exchange

Site

1

Site Submits AE/SAE(Fax, File Attachment,

On-line Form)

CROs

4

email notifi

cation

Sites

Sites

IRBs / ECs

3

Reportability to sites is determined to be required.

Safety Notification is uploaded to IntraLinks

Safety Notification / Letter

2

Sponsor AE Management & Reporting

System

Medical Assessment & Reportability

Determination

ROI From Moving the Clinical Trial Process Online

For sponsors, just getting to “FIRST PATIENT FIRST VISIT” for a Phase III study takes 22 weeks and $5.1M.

Projected industry spend in 2009: $8.8B** Based on the projected number of new Phase III and studies in 2009 of 1,725

With IntraLinks, sponsors can save 10 weeks and $2.1M savings per study.

Projected industry cost savings: $3.6B** Based on the projected number of new Phase III studies in 2009 of 1,725

Assumptions:75-site, 29-month studyA clinical trial costs $36K/day

6 Weeks$1.1 Million

16 Weeks$4 Million

104 Weeks$28 Million

Old Way

2 Weeks$.5 Million

10 Weeks$2.5 Million

IntraLinks Solution

Conduct StudySite Recruitment Study Start-up Close-Out

Document Distribution Process Online

1.5M safety packages/year

Overnight mail: $20/packagePrinting: $.06/page

1-2 business days for each overnight safety package

75,000 man hours (37.5 FTE)/year to execute 1.5M safety packages

No overnight mail or printing costs – simply post the safety document to IntraLinks

No time delay – Instant, simultaneous distribution of safety document via IntraLinks

566 man hours (28% of one FTE)/year to execute 1.5M SAE report distributions)

$30.1M/year

1-2 days/distribution

74,434 man hrs/year

Cost Savings

Time Savings

Human Resource Savings

Old Way IntraLinks Way

Calculated using real data from a Top 5 Pharma Company

gf1

gf1 You can comment that the pricing used in the model is based on published rates, and many of you may have negotiated significant discounts above and beyond these levels. Even if your company has half the documents in this example, and gets a 30% discount above what we've cited, the savings are still US$12M

Flow would be more logical if the IntraLinks Way was in the middle, and the savings was on the rightgfarfel, 14/10/2009

Top 10 Things to Consider in Selecting a Clinical Trial Portal1. Web-based Online access anytime, anywhere2. Secure Application, infrastructure, process &

personnel security3. Compliant 21 CFR Part 11SAS 70 Type II

4. Easy-to-use Familiar interfaceIntuitive

5. Fully Supported 24/7/365 live global support Multiple languages

6. Neutral Not tied to any one sponsor or CRONot tied to other services

7. Integrated Ability to integrate with backend systems8. Experienced Experienced and established software

providerProven track record of technology excellence

9. Global Global experience, presence and infrastructure10. Dedicated Has the ability to invest and scaleListens to the market, has a vision for the future

Q&A — Thank you

Alison ShurellVice President, IntraLinks Life Sciences Product Marketing

EMAIL: [email protected]: 212.342.7634BLOG: http://blog.intralinks.com/AShurellWEBSITE: www.intralinks.com

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the journey toward paperless clinical trials

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