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PharmaVOICE Editors' Blog

Showing posts with label clinical trials. Show all posts
Showing posts with label clinical trials. Show all posts

Tuesday, November 11, 2014

OnDemand Webinar: Handling Missing Data in Analgesic Clinical Trials


Handling Missing Data in Analgesic Clinical Trials; Dropouts, Regulatory Strategies and Practical Implications

View the recorded webinar today
Speaker: Neil Singla, MD, Owner, Managing Member, Lotus Clinical Research

When it comes to subject dropouts, an ounce of prevention is worth a pound of cure. Subject and study staff education can reduce dropout rates. The lecture will focus on educational paradigms designed to reduce dropouts and their efficacy. Regardless of technique, dropouts cannot be eliminated. When dropouts occur, they need to be statistically accounted for utilizing accepted imputation methods. In the recently released FDA draft analgesic guidance, a significant amount discussion was devoted to the appropriate statistical handling of missing data. Dr. Singla will provide a primer on accepted imputation techniques for acute and chronic analgesic studies.

View OnDemand: http://bit.ly/lotusreg14

Friday, October 17, 2014

OnDemand Available: 10 Killer Applications for Digital Signatures in the Life Sciences Enterprise


Originally Recorded:
Wednesday – October 1, 2014 / 01:00 pm EST/10am PT – Free Attendance

(if you registered previously, use the same email address)

Includes live polls and a Q & A session.

Overview:

Life sciences enterprises of all sizes are using digital signatures in a variety of ways across their business operation. They’re using this technology with their core quality management systems (QMS) and electronic document management systems (EDMS), as well as within various departments such as FDA-regulated clinical operations, manufacturing, field sales and service, research and discovery, and in non-FDA regulated back office applications.

Join us as we take a closer look at each of the 10 killer applications for digital signatures within a life sciences enterprise and uncover the tangible benefits that thousands of these enterprises are already enjoying. We’ll explore a number of real-world use cases involving these applications. Whether you’ve already deployed digital signatures within some of your departments or you’re still at the consideration stage, this webinar will be worth your while.

Topics include:
  • Defining standard digital signatures and their global acceptance in regulated applications
  • Considerations in using digital signatures for closed system applications throughout an enterprise for corporate governance
  • Strategies for deploying digital signatures in open systems for the front and middle office: collaboration and secure document exchange

Key Takeaways Include:
  • Discover new ways digital signatures can be used in the life sciences enterprise
  • Discover the value of digital signature automation for specific business processes
  • Learn the unique considerations for digital signatures in both closed and open systems from end-user case studies

Who Should View:
  • QA & Compliance
  • IT
  • COO
  • CIO
  • Department heads within: clinical operations, manufacturing, product management and project management
(if you registered previously, use the same email address)


Tuesday, September 2, 2014

September Digital Edition is now available

Digital Edition

The September issue of PharmaVOICE is now available in a digital edition.

http://www.pharmavoice.com/content/digitaledition.html?pg=1

Thursday, June 12, 2014

Move Aside, Paper: Capturing Clinical Trial Outcomes in the Digital Age


Almac article in PharmaVOICE

The FDA wants to hear from patients directly during clinical trials. Their “Voice of the Patient” initiative gives the FDA a broader perspective on outcomes across many treatment areas. Technology is more important than ever for collecting valuable, accurate, timely information from patients.
In this article, you’ll learn about:
  • The scientific realities of patient reporting
  • Misconceptions about paper-based survey tools
  • 8 keys to implementing electronic tools successfully
  • The eCOA landscape
  • How to choose the best solution
 Read this article now at http://bit.ly/almac-showcase

Mark Wade of Almac is featured

Friday, May 9, 2014

Data Driven Innovation through a Clinical Data Repository - Download White Paper

Clinical Data Respository

“Data” is the life sciences’ industry most valuable asset. To date, systems that support clinical trials have focused on collecting, cleaning, tracking, and analyzing data from individual clinical trials. Sponsors want to rely on clinical trial data to support critical decisions. This requires data from multiple trials be aggregated and delivered in a concise easily understood manner so that decisions can be made and appropriate actions taken.

In this white paper, you’ll learn about:
  • How a CDR provides advanced analytics for actionable insights
  • The critical role a CDR plays in a successful risk-based monitoring approach
  • The opportunity to easily share data with partners and external collaborators
  • How a CDR supports efficient reporting to regulatory authorities
  • Best practices for implementing a CDR
  • A pharma case study on implementing a CDR

Download this free white paper now at http://bit.ly/ecswhitepapers

Friday, April 11, 2014

April Feature Article - C-Suite: CROs: Opportunities and Barriers to Clinical Innovation

PharmaVOICE, Theorem

We asked c-suite executives throughout the CRO arena to provide their insights on what the biggest opportunities and barriers for innovation are for improving the drug development process, as well as identify a recent innovation that is improving the process.

Insights from John Potthoff Ph.D., President and CEO, Theorem Clinical Research.


Opportunities: Clinical trials today generate vast quantities of data that must be understood before they can be acted upon. The greatest opportunity for innovation in clinical development of biopharmaceuticals and medical devices lies in advanced software tools and techniques that allow real-time visualization of information in ways that speed understanding. In an era of risk-based monitoring and continual fine-tuning of trial design, connecting data streams with data visualization techniques provides a way for scientists to “see” multiple levels of data as they are generated, revealing new insights that can lead to better choices and decisions. As more and more data sources become available, this ability to visualize data will lead to an even deeper understanding of patients, products, and processes.


PharmaVOICE Feature Article April 2014


Read full article at http://bit.ly/pvdig38

Friday, January 3, 2014

How Working Together Effectively on a Clinical Trial is Like Doing a Successful Skydive - podcast

Barb Ruby
Barbara Ruby
Thought Leader: Barbara Ruby, Project Director, SynteractHCR, Inc.

In this episode, Ms. Ruby discusses how clinical trials are like skydiving, what some of the key challenges are in clinical trials, solving unexpected challenges, and creating a productive and collaborative relationship between CROs and sponsors.

Download Full Podcast

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podcast

Friday, October 11, 2013

How Site Engagement Improves Patient Recruitment Using a Clinical Trial Optimization System

TrialNetworks white paper

Using site engagement technology, sponsors are able to take greater control over patient recruitment by ensuring their study is top of mind with global sites. This white paper covers many of the issues related to site engagement, including a pharmaceutical company case study.

Download white paper

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download patient recruitment white paper today

Thursday, September 5, 2013

Risk-Based Monitoring for Late-Phase Research

PRA
Risk-based Monitoring White Paper
A number of factors are leading to the paradigm shift in the way that clinical research is conducted. The increasing cost of research and the adoption of EDC technologies that provide real-time access to data have forced the industry to look at optimized methods of conducting clinical studies. In addition, several studies have shown that 100% SDV may not result in higher data quality. All of these factors have led to increased interest in RBM strategies.

Download white paper
Risk-Based Monitoring for Late-Phase Research

Download Related Podcast
Risk-Based Monitoring for Late Phase: Implementation Strategies

Download Podcast Transcript

See All PharmaVOICE White Papers

See All PharmaVOICE Podcasts

Risk Based Monitoring

Wednesday, September 4, 2013

Risk-Based Monitoring for Late Phase: Implementation Strategies

Podcast and white paper clinical studies
Maria Harrison, Vice President, Late Phase Services, PRA
In this podcast, Maria Harrison discusses the past, present, and future of Risk-based Monitoring. She also covers challenges and solutions, as well as a real-life example of RBM in a clinical study.

Download Podcast
Risk-Based Monitoring for Late Phase: Implementation Strategies

Download Podcast Transcript

Download related white paper
Risk-Based Monitoring for Late-Phase Research

See All PharmaVOICE Podcasts

See All PharmaVOICE White Papers

Risk Based Monitoring

Monday, June 3, 2013

Learn How Artificial Intelligence Can Improve Pharma Efficiency


Pharmaceutical Efficiency

Friday, May 17, 2013

Global Clinical Trial Data Collection: A minefield or a walk in the park?

Global Telecom Testing
Image by Chris Pearson
Download this free white paper now.

Companies are losing clients and compromising their global clinical trials because the worldwide telephone numbers assigned to these trials are flawed. Participants and doctors calling to report critical trial data often cannot due to non-operational telephone numbers. The time and money spent to fix these faulty telephone numbers is costly, frustrating, and compromises the clinical trial and its success.

Provided by: Global Telecom Testing

Monday, February 4, 2013

Conducting User Testing to Improve Clinical Trial Technologies

Conducting User Testing to Improve Clinical Trial Technologies

In this episode, we discuss how user testing research improves the clinical trial process for patients, sites, and sponsors.

For more information about Almac, visit www.almacgroup.com.

Download Podcast

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Monday, January 14, 2013

Demystifying Routine Care Coverage in Trial Budgeting

clarify standard of care issues
Experts on Standard of Care
In this episode, we discuss standard of care in clinical trials, challenges for sites and sponsors, and how standard of care issues affect day-to-day work in trials.

For more information about Medidata Solutions Worldwide, visit www.mdsol.com.

Download Podcast

See all PharmaVOICE podcasts