Dear Colleagues,
Please find details below of three free, hour-long, educational web
tutorials relating to the use of EDC and IVR technologies to efficiently
manage the data, randomization and supply chain for a clinical trial. They
will be given from a scientific viewpoint, pros and cons will be presented
and they will not be Company promotional.
* Successful EDC Implementation
Dennis Wijnker (Principal Architect, EDC)
16th April 2007: 3.00 pm UK Time, 10.00am US East Coast Time
17th April 2007: 6.00 pm UK Time, 2.00pm US East Coast Time
* Basic and Advanced Randomization Methodologies
Damian McEntegart (Head of Statistics); Graham Nicholls (Product Manager)
18th April 2007: 3.00 pm UK Time, 10.00am US East Coast Time
20th April 2007: 6.00 pm UK Time, 1.00pm US East Coast Time
* Automated Medication Supply Chain Management
Todd Kole (Director, US Operations)
19th April 2007: 3.00 pm UK Time, 10.00am US East Coast Time
23rd April 2007: 6.00 pm UK Time, 1.00pm US East Coast Time
Visit www.clinphone.com/webinars to review full agendas (also reproduced
below) and register today!
If you are interested, please register at the link above - there is no need
to reply direct to me, although I am happy to answer any queries on content
or timing.
Kind Regards,
Malcolm
Malcolm Morrissey
Statistician
Clinphone Group Ltd
Lady Bay House
Meadow Grove
Nottingham NG2 3HF
United Kingdom
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Unifying Paper Data Entry (PDE) and EDC to Increase Trial Efficiencies
There is no question that EDC is here to stay. Yet, few companies are
implementing EDC on all of their trials and the majority of trials are still
paper based. As sponsors and CROs continue to “re-engineer the clinical
trial process”, what are the key factors they need to consider as they push
toward electronic systems? How can they put in place systems and processes
that will handle paper and electronic trials?
Dennis Winjker, Principal Architect, ClinPhone, discusses the issues and
solutions surrounding a unified PDE and EDC system.
Helping sites to move from paper to web-based EDC
Effective electronic query resolution for paper-based studies
Implementing one unified clinical data management platform to handle paper
and electronic studies
Develop successful data integration with other clinical technologies such as
IVR/IWR and CTMS
Streamline and unify electronic patient-reported outcomes (ePRO) data and
EDC
Minimize the impact of “re-engineering” the clinical process
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Basic and Advanced Randomization Methodologies
In today’s clinical trials, there is a notable increase in the adoption of
clinical technologies to electronically collect data and perform
randomization and automated supply chain management. These common processes
are frequently performed via Interactive Voice Response (IVR), Interactive
Web Response (IWR) and Electronic Data Capture systems.
These tutorials discuss how IVR, IWR and EDC technologies can be implemented
and used effectively. They are designed to provide study teams with a firm
foundation for evaluating the value of these solutions in a specific study,
and for contributing effectively to defining the requirements of a study
system. Further, integrating these systems to reach new levels of
efficiencies will be discussed. No specialist knowledge is required to
benefit from the tutorials.
Two statisticians with over 30 years of industry experience describe the use
of IVR systems in central randomization. Key topics include:
Benefits of IVR/IWR randomization approach
Methodologies available:
- blocked randomization (central, stratified)
- covariate adaptive randomization (minimization, dynamic hierarchical
balancing, Zelen’s)
Selecting the optimal randomization method
Randomization considerations for Open Label Studies
Benefits of IVR/IWR systems in Adaptive Trial Designs
Forced randomization – definition, and survey of existing practice
Randomization schemes that conserve trial supplies
EU and FDA regulatory considerations– definition and regulatory
acceptability
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Automated Trial Supply Chain Management
In today’s clinical trials, there is a notable increase in the adoption of
clinical technologies to electronically collect data and perform
randomization and automated supply chain management. These common processes
are frequently performed via Interactive Voice Response (IVR), Interactive
Web Response (IWR) and Electronic Data Capture systems.
These tutorials discuss how IVR, IWR and EDC technologies can be implemented
and used effectively. They are designed to provide study teams with a firm
foundation for evaluating the value of these solutions in a specific study,
and for contributing effectively to defining the requirements of a study
system. Further, integrating these systems to reach new levels of
efficiencies will be discussed. No specialist knowledge is required to
benefit from the tutorials.
Todd Kole, Director, US Operations, reveals the use of IVR/IWR in trial
supply chain management. Key topics include:
· How IVR/IWR systems automate the dispensing and trial supply chain
· Basic methodologies available:
- trigger/re-supply
- predictive algorithm
- just in time delivery
· Special considerations for managing dose titration studies
· Preventing treatment unblinding or partial unblinding
· Use of simulation for estimating supply requirements
· Impact on supplies of Adaptive Trial Designs
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