Dear Colleagues,

Please find details below of two free, hour-long, educational web tutorials 
relating to Interactive Voice Response (phone) or web equivalent systems.

Basic and Advanced Randomization Methodologies
Damian McEntegart (Head of Statistics); Graham Nicholls (Product Manager)
18th May 2006:  3.00 pm UK Time,  4.00 pm CET,  5.00pm EET,  10.00am US East 
Coast Time
22nd May 2006:  7.00 pm UK Time,  8.00 pm CET,  9.00pm EET,   2.00pm US East 
Coast Time

Automated Medication Supply Chain Management
Todd Kole (Director, US Operations)
19th May 2006:  3.00 pm UK Time,  4.00 pm CET,  5.00pm EET,  10.00am US East 
Coast Time
23rd May 2006:  7.00 pm UK Time,  8.00 pm CET,  9.00pm EET,   2.00pm US East 
Coast Time

Visit www.clinphone.com/webinars to review full agendas and register today!

The presentations will be discussing how best to use IVR (and web) 
technologies to efficiently manage the 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.
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
Statistics and Product Support Service Group
ClinPhone Ltd
Lady Bay House
Meadow Grove
Nottingham
NG2 3HF
United Kingdom

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Demystifying the Black Box: Basic and Advanced Randomization Methodologies & 
Automated Medication Supply Chain Management

Agenda
In today’s clinical trials, randomization and automated supply chain 
management are commonly performed via Interactive Voice Response (IVR) and 
Interactive Web Response (IWR) systems.
These tutorials discuss how IVR and IWR technologies can be 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. No 
specialist knowledge is required to benefit from the tutorials.

Basic and Advanced Randomization Methodology
Damian McEntegart (Head of Statistics), Graham Nicholls (Product Manager)
Two statisticians with over 30 years of industry experience describe the use 
of IVR/IWR systems in central randomization.
Key topics include:
How randomization is performed using IVR/IWR, and how end-users and 
stakeholders interact with the system
Blocked randomization schedules, the maximal procedure and dynamic 
allocation schemes
Selecting the optimal randomization method
Randomization considerations for Open Label Studies
Benefits of IVR/IWR systems in Adaptive Trial Designs
EU and FDA Regulatory considerations
Randomization schemes that conserve trial supplies
Forced randomization – definition and regulatory acceptability

Automated Medication Supply Chain Management
Todd Kole (Director, US Operations)
Todd Kole, Director, US Operations, reveals the use of IVR/IWR in medication 
supply chain management.
Key topics include:
How IVR/IWR systems automate the dispensing and medication supply chain
Major types of IVR/IWR medication management: trigger/re-supply, prediction, 
randomization code look ahead, just in time.
Adjusting supply algorithm parameters
Managing medication expiry and re-test dates
Special considerations in managing dose titration studies
Preventing treatment unblinding or partial unblinding
Forecasting medication supply requirements
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