According to The Motley Fool, CROs are a solid investment for investors because they have experienced substantial growth because of increased research and development outsourcing by the biopharmaceutical industry. They outline specific CROs to watch in the coming years. What do you think? In a tough economic environment--are CROs solid for investment?
According to this article in outsourcing-pharma.com the CRO Quintiles has collaborated with India’s Apollo Hospitals Group in order to increase its presence in the fast-growing Indian clinical research market. The new unit is being built will have a capacity of 50 beds, which will increase to 100 if demand is developed. Eddie Caffrey , Quintiles’ senior vice president, mentions:
“This new Phase I unit will draw on the existing experience of Quintiles staff in India, including our established cardiology group.”
According to a ClinPage, Kendle has opened a second office in western India. The new office in Ahmedabad continues its expansion in this area that is growing rapidly with CROs. They've operated in an office out of New Delhi since 2004.
How does a Sponsor and a Service Provider work together collaboratively as a Partnership? One of the ways is to establish a Governance Committee. The Governance Committee will cultivate a better relationship between the CRO and Sponsor.
When should a governance committee be established? How do you determine the membership of the Governance Committee? What should be in the Charter? What should the frequency be? What is the value of the Governance Committee and how will this be measured?
Here’s your chance to view our monthly newsletter that we send out to our Partnerships with CROs LinkedIn group with the latest updates in outsourcing and clinical development. Remember, to join our Partnerships with CROs LinkedIn group and update your email addresses on LinkedIn in order to receive it on an ongoing basis. Enjoy!
If you didn't have a chance to catch the web seminar "Project Management in the Life Sciences: Results from a 2008 Survey and Comparison with Previous Surveys over the Last Decade" with Dr. Jann Neilson of Wyeth, please do! It was a very informative session.
The Project Management Institute Pharmaceutical Specific Interest Group has sponsored 50-plus item surveys in 2001, 2002, 2005, and in the fourth quarter of 2008. There have been up to 711 respondents to each of the surveys. We have determined people’s profiles (e.g. what country they live in), the organization’s profile (e.g. large pharma, small pharma, biotech, CRO, consultant, etc.), and most of the questions were about project management in the person’s organization.
The seminar will describe the most interesting data from the 2008 survey and how it compares to previous surveys. For example, there will be a comparison of how project management occurs in large pharma, small pharma and biotech. Differences in how project management is performed in the US vs. EU vs. Canada will be shown. Comparisons between virtual and defined project management groups will be explored. Single vs. multiple function project management groups will be contrasted. These and other comparisons will be made in order to shown how project management in the life sciences is performed. As a bonus we will compare compensation and vacations in the US, EU and Canada.
Three dimensional data can now be globally accessible thanks to the CRO Data Integration System that was just successfully implemented today from Indiana, USA to China. This will allow CROs across the world to access pertinent information and make quick decisions regarding the research of pharmaceuticals, etc. Before the implementation of this system, files were too big to send to other research labs, causing much delay for an industry whose survival is now based on being the first to find and release valuable information. How will this effect the world of CROs? We'd like to hear your thoughts.
Applied Clinical Trials Online reports that patient recruitment is not just a bothersome in the U.S., but it also poses a problem when migrating overseas. Some of the problems that that arise in global trials are the different languages and cultural nuances that lead to multiple versions of the same materials. Another nuisance includes clearing materials through customs. This is a tedious process and can really delay clinical trials. Take a coupe of minutes to glance the article. What are some problems in patient recruitment that your company is currently experiencing?
Recently, we published that ICON had increased their expectations for earnings this year. Yesterday, PharmaTimes gave them the award Clinical Research Company of the Year.
The Chief Operating Officer, Alan Morgan, had this to say about the award:
"We are delighted with our success at the PharmaTimes awards, as it recognizes the outstanding contribution that our people have made to the overall success of the organization. ICON has established itself as a global service provider with an excellent level reputation for quality and service, which is down to the effort of our staff. We are very proud of the winners and all of our finalists."
ICON recently increased its expectations for earnings this year. The 2008 earnings per diluted share rose from $1.27 to $1.29, up from $1.23 to $1.26.
ICON CEO Peter Gray had this to say about the increase in earnings:
“For 2008 overall, we expect to report revenues in the range of $862 to $865 million, which is a modest reduction in previous guidance reflecting the impact of currency volatility over the last six months.”
This comes at a time when most CROs are lowing their profit and revenue outlooks. For more, read the article at Clinical Trials Today.
According to this post on outsourcing-pharma.com, the rising number of adverse events reported to institutional review boards is hindering clinical trials from protecting their patients. To alleviate this problem the Food and Drug Administration is recommending that all event information should be forwarded to the clinical trial’s sponsor first for initial analysis, if an “unanticipated problem” is detected, then it should be sent to an IRB. This as well as a lack of understanding of what adverse events should be classed as an “unanticipated problem” is adding to the problem.
International sponsors should be fully trained on what event information should be sent to IRBs in order to simplify this matter.
The Business Report of South Africa shares that the CROs in the country are seeing less funding from overseas. This is in large part due to the global financial crisis. The smaller tech companies they depend on for financing are delaying their release of money to the clinical trials. With at least 350 clinical trials based in South Africa every year, they'll have to find a way to attract more private investors to this area. Read more here.
According to an editorial in yesterday's New York Times, the F.D.A has a seemingly limited interest in clinical trials--and this may be to the detriment of quality food and drugs that are created through these trials. For instance, its a federal requirement that the makers of drugs or medical devices receive financial information from the scientists conducting clinical trials before the trials start and to inform the F.D.A of any conflicts, yet fewer than 1% of of makers report any discrepancies. Someone is lining their pockets and the F.D.A is turning their heads.
The agency’s lax performance underscores the need for Congress to pass legislation requiring all drug and device makers to report their financial arrangements with doctors in a public databank. That would make it harder for clinical investigators or sponsoring companies to hide potential conflicts, including those that might bias clinical trials for the F.D.A.
Do you agree with this editorial? What legislation should occur?
Even though there are several reports indicating the trend of outsourcing clinical trails to India, trials conducted in India only represent two percent of the worldwide total according to this article in Fierce Biotech.
The research group RNCOS also expects the number to surge to 5 percent by 2012 as more companies look to conduct low-cost trials in India.According to RNCO,
"companies can cut up to 30 to 40 percent time required to complete various phases of clinical trials choosing India as the outsourcing destination."
In a recent article at Pharma Exec, they look at the growing trend of making sure patients around the world are insured should they become injured during a clinical trial. Although regulations are different from country to country, those countries with no regulation for insurance for a clinical trial patient are limiting what a CRO can do. There have been a number of attempts to standardize clinical trial regulations across the globe, including the Good Clinical Practice Standards.
For an in-depth look at this story, read the article here.
According to research at RNCOS, India is one of the most economical destinations for conducting global clinical trials. Their research shows that substantial amounts can be saved in India on both staff and utilities. For instance, the salary of a clinical research associate is only 13% of that in the US and 17% and 19% as that in the UK and Germany respectively. Similarly, the cost of a biostatistician in India is only 15%, 18% and 17% as that in the US, UK and Germany respectively. Companies also save substantially on utilities and land while setting up their operations in India. For more information on RNCOS research, please click here.
Will India prove to be the premier destination for global clinical trials in this economic climate? What does your company to do compete with the relatively low cost of companies utilizing India's resources? Post your thoughts here or on our LinkedIn group.
Clinical Trials Today reports that CRO PPD has entered into a strategic collaboration with Merck to expand its global laboratory business.Under the agreement, PPD will have access to Merck’s 130,000 square foot facility in Wayne, PA as well as 80 employees who will operate there.
In return, PPD will provide Merck with range of assay development and immunogenicity testing services as well as traditional central laboratory and sample storage services over the next five years.This is the beginning of a trend of strategic agreements we have seen between CROs and big pharma.We have seen this in August 2008 when Covance partnered with Eli Lilly in a $1.6 billion contract research deal.
Will we see this trend continue between CROs and big pharma in 2009?
ClinPage recently featured some of the CROs that are dominant in the Brazil market. With over 300 employees in the region and at any given time 150 trials running, PPD, a Wilmington, North Carolina-basd company, dominates the region. They entered Brazil in 1995 when they bought Q&Q Suporte a Pesquisa Clinica, the first established CRO in Brazil. From there, PPD grew organically and spread through other countries in Latin America such as Mexico, Argentina, Chile and Peru.
Offering a 6 month certificate program in Clinical Research, Bilcare Research Academy in Bengaluru, India will aim to educate more Indians in Clinical Research to further advance their country's rise as a world leader in clinical research. We've reported on India before and we're keeping our finger on the pulse of this nation's advancements. What news do you have to share? What do you think clinical research will be like in 1, 10 or 20 years? We appreciate your input.
For more information on this program, please click here.
I came across this presentation from Ubio on slideshare that outlines general ethical guidelines to be followed when conducting clinical trials, especially overseas.Take a couple of moments to review it.
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