In our August/September issue:
PEER-REVIEWED ARTICLES
Logical Sourcing: Strategy Roadmap
Lee S. Scheible, Chris Bodurow, PhD, Karin Daun
With sponsors expanding their level of outsourcing and embracing deeper and more integrated third-party organization (TPO) relationships, the need for them to align their outsourcing and corporate strategies is critical. This article outlines the four essential steps for developing and implementing a logical sourcing strategy to ensure optimal clinical deliverables.
|
eSource Records: Keeping Things Simple
Jules T. Mitchel, Jonathan Helfgott, Tom Haag, Silvana Cappi, Imogene McCanless Dunn, Yong Joong Kim, Joonhyuk Choi, Timothy Cho, Dean Gittleman
While industry efforts to transform the clinical trial process have made substantial headway in recent years, the adoption of eSource solutions to collect and manage data continues to be slow. Authors present the FDA and EMA perspectives on eSource record-keeping and break down the process sponsors can follow to best satisfy regulatory concerns about EDC data integrity and how sites control their source records.
|
Patient De-identification: A Clinical How-To
Khaled El Emam, PhD, Kald Abdallah, MD, PhD
As the movement to increase sharing of clinical trial data intensifies—in efforts to help advance medical research and improve patient care—this report explores the key methods that can be used to de-identify clinical study data, and the relative strengths and weaknesses of each.
|
NEWS
View From Washington: Jill Wechsler on how the "Cures" bill and looming PDUFA VI reauthorization are big on including the patient voice in R&D.
View From Brussels: Peter O'Donnell reports on the drug development priorities in Europe for the years ahead, according to its top health chiefs.
Global Report: Philip Ward highlights industry efforts to recognize and address continued challenges in pediatric clinical trials.
Audit Trail: Tracking the sharp rise in number of FDA site audits.
|
CLINICAL TRIAL INSIGHTS
Patient-Centric R&D: ROI Expectations
Ken Getz
Many still consider “patient centricity” a buzzword, but clinical research stakeholders are using several key implementation and ROI metrics to measure the concept in action. |
CLOSING THOUGHT
'PRO' Payoff for Diabetes
Matt Reaney
Applying patient-reported outcomes (PRO) data in stride with clinical feasibility data is helping improve diabetes care and treatment. |
|
|
If you would like to submit an article to Applied Clinical Trials, contact Lisa Henderson, Editorial Director - lhenderson@advanstar.com
Applied Clinical Trials is free to qualified subscribers. To subscribe, click here.
Click here to contact the Applied Clinical Trials sales team. |
