Newsletter | April 25, 2012

04.25.12 -- Collecting PROs Via The Web

Clinical Leader
Collecting PROs Via The Web
By Shelia Rocchio, PHT Corporation
This article describes the web-based mode of administration for electronic patient reported outcome (ePRO). It explains which types of trials are best suited for this mode of administration, discusses psychometric validations required, and explains how and when ePRO data collected via the web can support a claim.
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The Post-Approval Summit, on May 1 and 2, 2012, focuses on strategies and best practices for demonstrating and improving the safety, effectiveness, value, and quality of healthcare products and services through Phase IV studies, Patient Registries, Risk Management Programs, and Quality Initiatives.

Featured Articles

Key Elements Of Observational Studies That Make Major Contributions To The Literature
Successful observational studies include three key elements: a protocol that asks interesting clinical questions, external advisors who are actively engaged, and an analysis approach that is modifiable. Read more.

Online Community Programs — Changing The Game
Drug companies and medical device manufacturing are addressing this issue by engaging a new channel of social technology — online community programs — being used to connect thought leaders, expand peer networks, foster collaboration, and advance the sharing of clinical information and experiences. Read more.

Implications Of Immunogenicity In Drug Development
Biotherapeutics emerged in the 1970s as viable alternatives to small molecule drugs when the advent of recombinant DNA technology allowed for cost-efficient, large-scale manufacture of proteins in cultured cells under controlled conditions. Read more.

Featured Multimedia

Blinded Diagnostics At Partnerships In Clinical Trials 2012
Paul Savuto and Steve Karrupan of Blinded Diagnostics discuss how sponsors and contract research organizations can utilize point of care technology to perform clinical trial testing.

Featured Products
Adverse Event Reporting, Safety, And Compliance Software
Adverse event (AE) reporting is a key process point for maintaining safety and compliance. Unfortunately, it's also incredibly labor-intensive. AE source documents arrive in just about any form — mail, fax, email, even voice records from call centers. Read more.
Wallet Technology
The wallet package is an effective marketing tool and a growing number of pharmaceutical companies are following the trend towards packaging their blister cards in wallet packs. Read more.
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