Tips and Trends on Global Clinical Trials Outsourcing

I came across this great podcast from PharmaVoice on their blog where Patrick Durbin, VP of Fisher Clinical Services, offers some best practices for developing a strategic partnership with outsourcing providers, discusses some of the biggest challenges and missteps in global clinical trials outsourcing, covers emerging opportunities at the global level, and lists some of the most important emerging trends in this arena. Take a couple of moments to listen to the podcast.

Play the PharmaVoice Podcast

Expert Opinions on the Current State of the CRO market

I came across this podcast from Outsourcing-Pharma.com where Barath Shankar, Frost & Sullivan analyst offers his opinion on the state of the contract research market now that it is having to evolve and adapt to the turbulent environment. The podcast is about 5 minutes long, so take a few moments to listen to it.

Listen to the podcast

March Partnerships with CROs LinkedIn Roundup

The March Partnerships with CROs LinkedIn Roundup is here! Read the newsletter here. If you haven't had a chance to join our Partnerships with CROs LinkedIn Group, join now!

We also had a special message from Lesly Atlas, the Partnerships with CROs Event Director, about what benefits you'll find at Partnerships with CROs as a LinkedIn member.

Premier Acquires Pivotal Research Centers

According to this article in Clinical Trials Today Premier Research, a CRO based in the UK, has finalized its deal with Pioneer to acquire Pivotal Research Centers, which is a site management organization that specializes in phase II and phase IIa clinical trials.

Pioneer’s president and CEO Bruce Shear recently mentioned, “The completed sale of Pivotal advances our plan to focus on our faster growing core business of delivering behavioral health care.”

More suicidal monitoring needed in clinical trials?

In a recent post by Dr. Michael McKelvey, he addresses the issue of suicide monitoring in clinical trials. He states that the number seeking regulatory approval is increasing. And the FDA has recently issued guidelines for the topic. However, there needs to be a fully structured, procedurally reliable and replicated process for monitoring suicidality. What do you think? Is this an issue for your clinical trials?

i3 Launches New Software to Manage Clinical Trials Activities

This article in Clinical Trials Today discusses how i3, a contract research organization, has launched a new web-based clinical trials and data management program that will replace the need for multiple systems to manage all of these activities.

i3 CEO Glenn Bilawsky mentions, “i3Cube was designed to provide our clients and clinical investigators with a simple, easy-to-use, and streamlined experience. We brought together our use of proprietary health care claims data with our clinical research expertise and developed i3Cube to create time and cost efficiencies for our customers.”

It will be interesting to see what other web-based applications will be released in the upcoming months to help improve efficiency in outsourced clinical trials.

Staffing services now offered by PharmaNet

CRO PharmaNet has expanded its services to now provide clinical trial staffing which will include on-demand staffing, strategic alliances, functional service staffing and quality control services.

PharmaNet president and CEO Jeffrey P. McMullen said "Our solutions-based staffing business provides another entry point with large pharmaceutical clients by offering them a new alternative with PharmaNet quality built-in."

For more on the story, read here.

Contract work for clinical trials on the upswing

The Pharma Times reported yesterday that 84% of respondents claimed that they'd be interested in contract work when it comes to clinical trials.

While the perceived benefits of contracting – better remuneration, independence and flexible working – were offset in the survey by inhibitions about job security and loss of company benefits, 55% of the respondents recognised there was an increasing shift towards contract-based employment in the sector, with more than 20% seeing it as the prevailing dynamic.

For the complete article, read here.

A New Low in Drug Research: 21 Fabricated Studies

According to WSJ.com, Baystate Medical Center in Springfield, Mass., has asked several anesthesiology journals to retract the studies, which appeared between 1996 and 2008, the WSJ reports. The hospital says its former chief of acute pain, Scott S. Reuben, faked data used in the studies.

Some of the studies reported favorable results from use of Pfizer’s Bextra and Merck’s Vioxx, both painkillers that have since been pulled from the market. Others offered good news about Pfizer’s pain drugs Lyrica Celebrex and Wyeth’s antidepressant Effexor XR. Doctors said Reuben’s work was particularly influential in pain treatment and that they were shocked by the news.

Read more on the WSJ.com's health blog.

CROs in disguise

Brian Orelli at The Motley Fool writes on the basics of CROs, or CROs 101 for the non-industry professional. Orelli outlines a few characteristics of CROs but what was most interesting was his claim that some CROs can be disguised and, according to Orelli, it seems (to me) that pharmaceutical companies are essentially turning into holding companies that license or purchase drug candidates, escort them through the regulatory maze, and produce and hock them once they get past the FDA. Which he claims isn't a bad business model. Check out his piece here and let us know your thoughts.

Omnicore's CRO sees 2008 profit

At the CRO, Omnicore Clinical Research, operated by Omnicore, they reported an adjusted profit of $17.6 million profit from the 2008 year, up from $13.1 million in 2007. Before the profit was adjusted, they saw business totaling $49.1 million. For more, read this article.

Tigermed, MacroStat forge Chinese CRO alliance

According to PharmaTimes.com, the two CROs will pursue “extensive strategic partnership” in clinical trial management, data management and statistical analysis. The alliance will broaden the scope of MacroStat’s operations and “add professionalism to Tigermed’s biostatistics services”, the latter said. With the new alliance, will more work be outsourced to China? We'd like to hear your thoughts.

Tough Economy Slows Down CRO Growth for now

According to this article in Clinical Trials Today recent layoffs in the pharmaceutical industry has slowed down CRO growth in short term, but in the long run improving efficiency and controlling costs will result in more opportunities for CROs.

Oncology is expected to become a huge focus in the future, so CROs with strong oncology franchises should reap the benefits from that trend soon. It is said that the oncology market will grow to approximately $80 billion in global sales by 2012. European CROs are also making headway as the two Italy-based CROs, Phidea and Marvin Research have completed their merger.

What are some other trends that can help boost CRO growth in the near future?

What's your opinion?

In the most recent issue of the Partnerships with CROs LinkedIn Roundup, we asked several questions of our attendees about Sponsor-Site relationships. Now is your chance to weigh in! If you haven't had a chance to joined our LinkedIn group, join today! We'll reveal the results in our March LinkedIn Round Up newsletter.

Are you seeking new ways to improve your relationship with your sites?

Is finding a quality investigator proving to be increasingly difficult?

Win Through a Social Contract: Use Teamwork to Create Value, Develop New Strategy, Iterate Quickly, and Implement

Nilofer Merchan's great post on MarketingProfs.com, outlines the process to achieve a high level of teamwork, an organization must hold a set of core beliefs that are central to how strategy is created and carried out. These core beliefs are the common thread that weaves together the framework and rules of engagement that enable people to collaborate in such a way that they can create powerful strategies together. Valuable information for CROs and management, indeed. What other strategies to you have for successfully implementing a process?

Revisiting Ethics of Global Outsourcing

On his blog, Global Bioethics, Stuart Rennie discusses a topic that we covered last week concerning unethical outsourcing practices. Rennie's take includes, "It is a charming idea that ethics committees would be responsible for stimulating the globalization of research (and indirectly, the ethical problems that go with it), but it seems more likely that streamlining the processes at home will simply increase the number of trials abroad, as long as the economic disparities between countries remain in place. You will simply get your IRB approval faster. Besides, if you want to 'de-incentivize' clinical trials abroad, why not build up ethical review in developing countries, or force pharmaceutical companies to pay to build local health infrastructure and capacity as a cost of doing business, rather than scaling down IRB processes at home?" We encourage you to post your comments here or on Mr. Rennie's blog.