Improve
process today, position for tomorrow!
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This
"how to" workshop will give you all the
specific,
critical issues that need to be addressed by
any successful EDC implementation.
If you want a comprehensive roadmap
with an individual focus, this is the workshop for
you!
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Location
& Dates:
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King
Of Prusssia, PA
(near Philadelphia)
Princeton, NJ
Baltimore, MD
(near BWI airport)
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March 13, 2003
March 20, 2003
March 27, 2003
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Cost:
$525
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Includes
attendance, continental breakfast, afternoon snacks, handouts,
and certificate of attendance.
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Course
Description:
The
move to Electronic Data Capture (EDC) is driven by the promise
of decreasing the time spent collecting clean clinical data
and obtaining FDA approval.
This is a hands-on workshop that delves into the world of
electronic data capture and gives you the tools to assess
what EDC means to you and your company.
Click
Here to Register
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We
will cover the following specific areas:
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Program
Management
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Initiating a program
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Creating
program oversight team
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Determining
your current state of clinical trials and data collection
(number and type of trials run, sites used, patient diaries,
etc.)
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Determining
objectives of initiative (100% EDC or partial EDC, 1 vendor
or multiple vendors, outsourced, in-house, or direct collection
of data)
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Developing
EDC business requirements
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Developing
initial budget
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Developing
a change management strategy
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Selecting
an initial study and/or trial
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Defining
metrics for performance and quality
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Forming
a vendor selection team
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Reviewing
standard operating procedures (SOPs) with EDC in mind
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Mapping
out process changes
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Engineering
new procedures
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Identifying
other computer systems that need to be integrated with EDC
system
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Developing
integration requirements
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Developing
data transfer requirements (including creation of statistical
datasets)
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Defining
new project milestones and management reports
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Developing
requirements for management reports
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Forming
EDC standards team to develop standard forms and screens
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Vendor
Selection Team
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Identifying/contacting/attending
demos of potential vendors
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Evaluating and selecting
vendors
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Selecting patient diary
tools/direct data capture devices
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Regulatory
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Reviewing 21 CFR Part 11 and other applicable regulations
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Adding
computer system(s) to validation master plan
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Training
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Developing
an education program for bringing affected employees on board
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Study
Management
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Creating a project plan
for the EDC study
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Site
Management
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Selecting
initial sites
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Developing a site assessment
strategy
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Performing
initial site assessments
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Monitoring
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Developing
a monitoring plan for initial EDC study
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Data
Management
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Developing
a data management plan for initial EDC study
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Standards Team
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Reviewing
developed objects (items, forms, tables, etc.) for inclusion
in Standards library
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| Course
Agenda |
| 8:00
- 8:30 AM |
Registration
and continental breakfast |
| 8:30
- 10:00 AM |
Introduction
to EDC, workshop objectives, evaluating where your
company is. |
| 10:00
- 10:15 AM |
Break |
| 10:15
- 12:00 noon |
Review
of case scenarios and attendee situations. Introduction
to EDC marketplace. |
| 12:00
- 1:15 PM |
Lunch |
| 1:15
- 2:45 PM |
Address
problem areas, change, training, and adoption strategies. |
| 2:45
- 3:00 PM |
Break |
| 3:00
- 4:30 PM |
Plan
for EDC adoption. |
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Course
Objectives
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You
will learn to:
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Assess
the composition of current studies and processes
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Identify
process inefficiencies
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Identify
future objectives
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Plan for changes
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Review
the EDC Market and some key vendors
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Develop
a plan to adopt EDC or evaluate your current plan
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Attendees
should come prepared to discuss specific scenarios related
to their own trials.
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Click
here to Register
Limited
Seats Available:
To ensure each individual gains the
maximum benefit from the workshop, registration is limited
to 25 participants. Please register early to ensure a place.
Cancellation
policy:
A full refund of the workshop registration
fee will be made for attendee cancellations made at least
3 weeks prior to a workshop. Registrants who do not cancel
more than 3 weeks prior to the workshop are liable for the
full fee. Substitutions may be made at any time.
Payment:
We accept checks, VISA, Amex, and
Mastercard. Please note that payment is required before the
workshop.
Disclaimer:
We reserve the right to cancel a
workshop. We are not responsible for covering airfare, hotel,
or other costs incurred by training course registrants.
Click
here to Register
Before
each course begins, all enrollees will receive a confirmation
letter.
Customized training
or group events:
To bring this workshop to your company
or to have a workshop custom designed for your organization,
contact Al Perelli at 484-530-0300 or aperelli@edcmanagement.com.
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What will you learn? |
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Practical
knowledge you can apply in your job.
Attendees will learn what EDC can do for their organization.
They will learn to evaluate their own studies and determine
if they are ready to proceed with EDC.
Attendees will also get a feel for different vendor
offerings in the marketplace, and guidelines for where
they might acquire information and/or products.
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| Who
should attend? |
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Anyone
involved in their companies’ EDC initiative.
Everyone who works with collecting clinical trials data
should attend this workshop. If you work in Clinical
Research, Data Management, Project Management, Product
Management, Monitoring, Statistical Analysis, and Investigational
Site Services departments, you should attend.
This workshop discusses many areas that impact the jobs
of CRAs, CDCs, CDMs, PMs, Programmers and Analysts,
CRC, Investigator site personnel, and other clinical
trial professionals. |
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About
EDC Management
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EDC Management is an experienced,
independent voice in the preparation, planning and
implementation of Clinical and Data Management and
Electronic Data Capture (EDC) solutions for the
biopharmaceutical industry. EDC Management publishes
well-researched and timely information about Electronic
Data Capture technologies and processes as well
as provides focused consulting services.
We do not sell or endorse any specific EDC software
application or vendor.
EDC Management is the leader in Clinical and Data
Management and Electronic Data Capture consulting
services.
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| About
the presenter: |
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Kirk
Mousley is co-founder, Vice President, and Chief Technology
Officer of EDC Management. He received BS and MS degrees
in Electrical Engineering from MIT and a PhD in Computer
Science from Lehigh University.
He has been the President of Mousley Consulting, Inc.
since it's founding in 1993 and has directed the company's
efforts in the areas of clinical database design,
data editing/cleaning, document management, and submissions. |
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