Risk Based Monitoring and SDV: Increased Adoption of ECM

By Venu Mallarapu | Published: March 20, 2012

It is a universal fact that the escalating costs of discovering new medicinal products are driving sponsors and CROs to scrutinize every dollar spent in the process. The situation is escalating fast as pressure mounts with the blockbusters of yester years come off patents. This means that there is a need for all the stakeholders in the value chain to revisit their approach to existing processes and come up with innovative ways to save costs. Read More »

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Technology Targets Recruitment

By Robert Koolen | Published: March 16, 2012

Educating patients about relevant clinical trials remains a huge challenge, and while formal recruitment efforts are important to hitting participant numbers, building awareness among patients can go a long way in lifting enrollment.

Robert Koolen

Robert Koolen

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Subjects Want Results

By Tim Denman | Published: March 15, 2012

At the end of January, CBI hosted the Patient Centricity in Clinical Trials conference in Philadelphia, PA. At the conference, Joseph Kim, Director of Clinical Operations at Shire, mediated a patient panel focused on their experiences participating in a clinical trial. Read More »

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European Clinical Trials Approval—Centralized or Decentralized?

By Peter ODonnell | Published: March 14, 2012

So which way will it go? A breakthrough to a single approval for clinical trials in Europe, or stuck in the same old system of multiple approvals required in each country—and even each center?

This is what the debate about the planned revision of Europe’s clinical trials rules is coming down to. The discussion came to a head in early March when the European Union’s Health Commissioner, John Dalli, told an industry audience that he doesn’t favor a centralized system. Read More »

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Patients Views of Clinical Trials

By Lisa Henderson | Published: March 9, 2012

My five-year anniversary with Applied Clinical Trials was March 1, and one thing I know is that the focus on the patient in clinical trials—and in healthcare in general—has definitely changed over this time.

The participants in clinical trials, potential patients and those that are or have participated, are the people that can provide input into a trial’s design; the protocol; data collection needs; and quality of life issues among many others. Read More »

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One Patient’s View of Clinical Trials

By Reid Paul | Published: March 9, 2012

At the Partnerships in Clinical Trials 2012 show last week, Applied Clinical Trials sat down with Emily Shaller, founder of Rock CF Foundation, a group focused on raising money and finding a cure for cystic fibrosis, to better understand clinical trials from the perspective of a patient.

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Non-Profit CRO Addresses Underserved Markets

By Lisa Henderson | Published: March 8, 2012

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Using Crowdsourcing to Improve Decision Making and Innovation

By Kayda Norman | Published: March 7, 2012

To be honest, when I first entered the session, “Crowdsourcing Clinical Development and Medical Innovation,” with speaker James Surowiecki, columnist for The New Yorker and author of The Wisdom of Crowds, I had no idea what to expect. I had never even heard of crowdsourcing before, but took the fact that the room was slowly beginning to fill with other attendees as a good sign.

Turns out, crowdsourcing refers to using the collective wisdom of crowds in order to make a decision or solve a problem. As Surowiecki noted, “under the right conditions a group of people can be more intelligent than the smartest person in the group.” Read More »

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Virtual Trial Innovation

By Tim Denman | Published: March 6, 2012

One of the biggest news items in the industry these past few months has been Pfizer’s REMOTE trial and the effect virtual trials could have on the industry. It seems like technology increases and improves daily, causing all industries to look for ways to best leverage new technology. In the clinical trials space, increased technological functionality is leading the industry to explore the idea of a virtual trial.

It is this interest in conducting a trial primarily in the virtual space that led Partnerships in Clinical Trials to offer the Virtual Clinical Trials Consortium track at yesterday’s Executive Summit. Read More »

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Operational Excellence?

By Tim Denman | Published: March 6, 2012

In preparation of the opening of the education sessions today, I scanned the titles of the six tracks and began to analyze the one title that stuck in my head: Operational Excellence.

The term operational excellence can be interpreted any number of ways. I began thinking about what the phrase meant in the clinical trial space and what it meant to others in the industry. I decided to survey the track’s presenters, asking them simply: “What does operational excellence mean to you?” Read More »

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