Parexel Completes Chinese Bridging Study

According to this article in Clinical Trials Today, the contract research organization Parexel has completed a Chinese bridging study to be conducted outside of China at their Los Angeles facility. Parexel recently acquired California Clinical Trials (CCT), which does a number of ethnobridging studies.

Michelle Middle, corporate vice president and worldwide head of Clinical Pharmacology at Parexel mentions:

“The goal of Parexel clinical pharmacology is to help sponsors to get as much information as soon as possible in drug development.”

Briding studies have grown increasingly important to clinical research, as more and more companies are looking to cut back on costs.

Biotrial, Full-Service CRO and European Leader in Drug Evaluation and Pharmacology Research, Appoints New Head to Manage its Growing Data Management

From PRWEB:

Biotrial, a leading CRO for early phase clinical trials, today announced that Monique Duguépéroux-Klocke has joined the company as its new Head of Data Management.
Rennes, France (PRWEB) November 15, 2008 -- Since 1989 Biotrial has provided consistent and reliable clinical data management for in-house clinical trials, as well as complex global clinical studies. From CRF design, data entry, database design, data validation, statistics and consulting, to name a few, Biotrial's experience includes a wide range of therapeutic areas.
Monique Duguépéroux-Klocke brings over 15 years of experience in the field of clinical research. After leaving a well-known CRO (PAREXEL in Berlin) she worked for over 10 years at one of the top French pharmaceutical companies: Servier Laboratories, as head of the Data Management, Outsourcing Department.
"We are really excited about these new changes in Biotrial's Data Management department," said Isabelle Cimarosti, Director of Biometrics Department. "Monique Duguépéroux-Klocke's arrival attests to our growth and reinforces our position as a global service provider."

To read the rest of this article, click here.

Parexel and ClinPhone

We recently reported the deals that the Encorium Group, as well as Covance have made. In latest news as reported by PharmaLive, Parexel announced closure on the deal to acquire ClinPhone. This will help both companies become leaders for eClinical technologies. This is inline with the trend of growth within the contract research organization industry.

Josef von Rickenbach, Chairman and CEO of Parexel, released this statement regarding the acquisition:

"Biopharmaceutical companies require robust technology solutions to increase the efficiency and productivity of clinical research. This is especially important given the growing complexity and global nature of clinical studies today. We believe this acquisition further solidifies PAREXEL's leadership in providing integrated clinical and technology expertise. Combining the sophisticated, in-depth capabilities of Perceptive and ClinPhone represents a major step forward for PAREXEL in meeting increased industry demand for a truly comprehensive eClinical platform."

Patient recruitment beginning sooner in Phase I

According to this article at Clinical Trials Today, trial design and regulatory consulting is experiencing a surge in Phase I of clinical trials. Most companies going to CROs are looking to make quicker decisions, and are also looking for someone to provide thought leadership.

This article focuses on Parexel, who’s conforming to the demands of the customers and moving the patient recruitment step to the first possible phase.

Michelle Middle, vice president and leader of Parexel’s worldwide pharmacology business had this to say about the change:

“Traditionally, Parexel’s phase I work focused on healthy volunteers, but we are moving more towards early drug development, which includes proof-of-concept work. We are seeing, across the board, that sponsors are seeking patient volunteers [intent-to-treat subjects] as soon as possible in phase I. We review every potential protocol we receive from a scientific point of view and suggest to sponsors, if it is necessary, different study designs.”

The efficiency of the systems must be kept up when dealing with this new way of running the trials. Timelines must be maintained, as well as the retention of healthy patients who are participating in the trial.

Outsourced Drug Trials Are Expected to Grow

About 25 percent of all preclinical drug testing is already outsourced to CROs, but according to this latest article in the International Herald Tribune, it is expected to grow to 50 percent in three years. Over the next five years, larger CROs are expected to absorb many specialized companies to boost their diversity. This expectation has already lift shares of CROs such as Covance and Parexel International, which were in stock market trouble this year.

Drug companies save millions of dollars each year by outsourcing clinical trials to CROs since it eliminates the need to build its own laboratories and researchers are not needed. David Windley, an analyst with Jefferies mentions as long as drug makers "keep trying to develop new drugs, then you have to do a lot of work. What they're then doing, they're turning to outsourcing in a more cost-efficient way."