The Workshop

PRE-CONFERENCE WORKSHOP
Monday October 20 2008
Michele Carnevale Associate Director, Client Services CLINPHONE	Julia Castellanos Associate Director, Client Services CLINPHONE
A holistic view of clinical trial supply
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 (EDC) systems. These electronic solutions offer great benefits including automated shipping and reduced wastage of medication. Also, simulation can provide deep insights into the behavior of the supply chain and is a powerful tool for planning manufacturing runs and other important aspects of any clinical trial. This workshop will touch on all of these areas and also discuss the electronic solutions now available to efficiently manage the drug accountability process.
Agenda
1:30	Registration
2:00	Session 1: How IVR/IWR systems automate the dispensing and trial supply chain Basic methodologies available: trigger/re-supply, predictive algorithm and just-in-time delivery Special considerations for managing dose titration studies
3:00	Afternoon refreshments
3:30	Session 2: Preventing treatment unblinding or partial unblinding Use of simulation for estimating supply requirements Electronic management of the drug accountability process Impact on supplies in adaptive trial designs
	Relevant industry case studies will be presented throughout the workshop.
About ClinPhone
ClinPhone is the largest and most accomplished Clinical Technology Organization (CTO) with experience in over 2000 clinical trials spanning 90 countries and over 70 languages. The company’s experience includes Phase I to Phase IV studies, ranging from single center studies with 20 patients to “mega trials” with over 40 000 patients. ClinPhone’s product portfolio, consisting of software and services, is backed by continuous research and investment in the latest technologies, coupled with extensive in-depth clinical industry experience. Its industry-leading software solutions include electronic data capture (EDC) and clinical trial management systems (CTMS) which can be licensed or implemented as hosted solutions. Delivered via its renowned Interactive Voice Response (IVR) and Interactive Web Response (IWR) platform, ClinPhone offers randomization, trial supply management, trial supply simulation, electronic patient reported outcomes (ePRO) and patient recruitment solutions. ClinPhone’s products can integrate, taking the pain out of juggling and managing multiple sources of disparate information. This approach provides more control over data, improves data integrity and streamlines the data validation process.