May 27, 2019process

The Waife Approach

Rethinking Change Orders

June 16, 2011

A while back, we ran an article about Joseph Anderson, principal associate at Waife & Associates. He is advocating a new approach to how change orders are handled. Change orders, of course, are ubiquitous invoices for unplanned aspects of a clinical trial. Clinical research is inherently unpredictable. Sponsors frequently decide to change course. Service providers must respond to such changes without being penalized by the financial impact of the new direction. And as a few publicly traded contract research organizations (CRO) have stated in their financial statements, change orders can represent a massive source of revenue. So much so that CROs can anticipate change orders and underbid on their proposals to handle some trials. It's axiomatic that phasing out change orders could send a tremor or two through the financial foundation of the CRO industry. Surprise Me Anderson, to be fair, is viewing the change order almost as a therapist, seeing…more...

Icon's Safety System

With The End In Mind

June 10, 2011

The pace is glacial. But everything the pharmaceutical industry does is becoming more centralized, more standardized—and more electronic. Electrocardiograms (ECGs) are one example. Another is the computer-aided review of endpoints in…more...

Faux Partnerships

Obituary For Change Orders?

December 01, 2010

Purveyors of clinical trial happy talk would have the industry believe that every clinical trial is an alliance of organizations with the permanence and seriousness of NATO—that every outsourcing engagement is…more...

Clinical Efficiency Series

Do CROs Help?

October 05, 2010

Sponsors are not only dissatisfied with the efficiency of their outsourcing relationships, but are also increasingly dissatisfied with their outcomes. The percentage of sponsors that is satisfied with the performance of…more...

Ethics Study

Rewarding for Recruitment

May 10, 2010

In watching respiratory therapists recruit for two studies under way in her departments at both Mount Sinai Hospital and SickKids Hospital in Toronto, neonatologist Sharon Unger thought she saw a trend. It appeared that respiratory therapists were talking to far more parents about entering their infants into the large, multi-center trial that rewarded recruiters for successfully enrolling…more...

Performance, Rewarded

Quintiles Elite Site Program

March 23, 2010

Quintiles has shifted its prime sites program into high gear. A bit more than two years ago, the contract research organization (CRO) had just one site designated as prime, meaning it had reached the top of the heap as a voluminous and consistent source of patients with a healthy smattering of investigators across a variety of therapeutic…more...

New Perspective

IAPO Seeks Patient Input

February 23, 2010

If the International Alliance of Patients Organizations (IAPO) gets its way, patients will soon sit at the table with scientists to offer input into the design of study protocols. Not in a forceful or adversarial way, says Jeremiah Mwangi, IAPO's senior policy officer, but in a way that benefits everyone. Picture, for example, a pediatric epilepsy trial…more...

Tech Overload At Sites

Sanofi’s Relationship Overhaul

January 22, 2010

When French pharmaceutical company Sanofi-Aventis (SA) recently gathered representatives from several investigator sites to ask them for feedback, the drug maker got a shock. An SA executive began to talk about an electronic collaboration portal, one where sites could interact with the sponsor, and he got cut off by what amounted to boos and hisses. “Turned out,…more...

Rising Star

Medpace Rated Highly

The CRO is loved by sites and has ex-FDA scientists in top executive positions.

Covance Case History

Six Sigma and CRF Pages

The contract research organization recounts using process-refinement tools to track CRFs.

ARG Joins in U.S.

CRO Network Expands

ARG has become the first U.S. partner—a Europe-based cluster of small CROs that work together on global trials. A what? We explain…

Biotech Focus

Synteract Still Growing

San Diego-based Synteract has its eye on global expansion and an offering for financiers.

Survey Lessons

J&J on Informed Consent

BBC criticism spurred J&J to look more closely at its informed consent form.

It's a Stellar Fit


INC and MDS Pharma talk to ClinPage about their upcoming nuptials.

Friday News

Excel, PFC Pharma Team Up

Bulletins from Generex, Arena, Campbell Alliance and UCB.

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