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Showing posts with label CTC. Show all posts
Showing posts with label CTC. Show all posts
Friday, March 13, 2009
Friday, February 20, 2009
Research Analysts Reveal Trial Sites Want more EDC and Recruitment Investment
This article in outsourcing-pharma.com discusses according to a research report conducted by clinical research industry analysts at CenterWatch, study site operators want a greater use of EDC technologies and more pharma investment in order to improve patient recruitment and efficiency in clinical trials.
The growth of trials in developing countries and in Central Europe and Eastern Europe has increased the need for improvements in EDC. Have you seen a massive shift in the pharma industry using EDC technologies?
The growth of trials in developing countries and in Central Europe and Eastern Europe has increased the need for improvements in EDC. Have you seen a massive shift in the pharma industry using EDC technologies?
Tuesday, February 17, 2009
Cytel’s new software Increases Efficiency of AstraZeneca Clinical Trials
According to this article in outsourcing-pharma.com AstraZeneca has installed a custom version of Cytel’s East clinical trial design software in an effort to improve data handling and ensuring compliance with Clinical Data Interchange Standards Consortium (CDISC) guidelines.
These tools aid smaller clinical trials companies assess their trials at the halfway stage, potentially reducing the amount of money spent for the company. It will be interesting to see what other clinical trials companies will begin using Cytel’s new software.
These tools aid smaller clinical trials companies assess their trials at the halfway stage, potentially reducing the amount of money spent for the company. It will be interesting to see what other clinical trials companies will begin using Cytel’s new software.
Wednesday, February 11, 2009
Pfizer Discloses Payment Information for Clinical Trials
According to this article on outsourcing-pharma.com Pfizer will disclose payments made to principal investigators, major academic institutions and research sites involved in Phase I to IV trials that exceed $500 a year and non-monetary items such as meals that cost more than $25.
Pfizer is getting closer than any drug maker in terms of full disclosure, but if the Physician Payments Sunshine Act of 2009 is passed into law, it would require companies to disclose all payments exceeding $100 a year and would face a fine of up to $1 million if they do not comply.
Pfizer is getting closer than any drug maker in terms of full disclosure, but if the Physician Payments Sunshine Act of 2009 is passed into law, it would require companies to disclose all payments exceeding $100 a year and would face a fine of up to $1 million if they do not comply.
Friday, February 6, 2009
Phase Forward Reports Strong Earnings
We recently posted that Covance’s revenues for their fourth quarter was up, despite the downturn economy. Today I came across this article on ClinicalTrialsToday that discusses how another clinical trials company, Phase Forward, has also reported strong earnings this past quarter. Their revenues for the 4th quarter were $48.3 million compared to $37.8 in Q4 the previous year.
Will we continue to see this trend in clinical trials companies when they report their 4th quarter earnings?
Will we continue to see this trend in clinical trials companies when they report their 4th quarter earnings?
Tuesday, February 3, 2009
Covance Revenues are up despite the Downturn Economy
ClinicalTrialsToday.com reports that Covance, biopharmaceutical drug development services company, has released very strong 4th quarter earnings in early and late-stage development segments.
Total revenue and net revenue are up from the same period last year, even though the state of our economy has faltered in the last couple of months. Joe Herring, Covance chairman and CEO, recently mentioned in a company release that:
"reduced demand in our Early Development segment from a combination of a lower level of new project initiations and increased project delays in our toxicology and clinical pharmacology services led to a sequential decline in segment revenue and operating income."
It will be interesting to see 4th quarter earnings of other clinical trials companies and see if they had comparable results.
Total revenue and net revenue are up from the same period last year, even though the state of our economy has faltered in the last couple of months. Joe Herring, Covance chairman and CEO, recently mentioned in a company release that:
"reduced demand in our Early Development segment from a combination of a lower level of new project initiations and increased project delays in our toxicology and clinical pharmacology services led to a sequential decline in segment revenue and operating income."
It will be interesting to see 4th quarter earnings of other clinical trials companies and see if they had comparable results.
Monday, January 26, 2009
GAO Criticizes the FDA’s ability to Oversee Clinical Trials
According to this post on outsourcing-pharma.com, the US Department of Health and Human Services has identified that the FDA has failed to provide sufficient oversight to ensure the protection of patients participating in clinical trials. This has in turn caused the GAO to conduct its own investigation of the FDA’s ability to oversee clinical trials, which started in 2007. The GAO is highly concerned that the FDA is not analyzing the impact age has on the safety and efficacy of the drug when the drug generally treats conditions for the more elderly.
Wednesday, January 21, 2009
Senator Criticizes Transparency Laws in Clinical Trials
According to this article on outsourcing-pharma.com, Senator Richard Moore has criticized laws in Massachusetts that enable pharma companies to hide payments made to physicians conducting clinical trials.
Moore believes that gifts and monetary compensation is public information and that it should not be hid from everyone. Moore later mentions:
“Patients and consumers generally have no idea what kind of relationships exist between their doctors and pharmaceutical companies or medical device manufacturers, relationships that result in billions of dollars per year in payments to health care practitioner.
Do you think that payments for physicians conducting clinical trials should be hid?
Moore believes that gifts and monetary compensation is public information and that it should not be hid from everyone. Moore later mentions:
“Patients and consumers generally have no idea what kind of relationships exist between their doctors and pharmaceutical companies or medical device manufacturers, relationships that result in billions of dollars per year in payments to health care practitioner.
Do you think that payments for physicians conducting clinical trials should be hid?
Tuesday, January 20, 2009
Clinical Investigators Financial Information
Released this month, The Food And Drug Administration’s Oversight Of Clinical Investigators’ Financial Information is now available. Read the document here.
Friday, January 16, 2009
Clinical Trials Thrive Through an Economic Downturn
Bob Coughlin, the president of the Massachusetts Biotechnology Council, believes that even though we are in the middle of an economic downturn, clinical trials are going through an economic boom according to this latest post on Applied Clinical Trials.
The rest of the post highlights their huge success in 2008, showing that their annual growth rate in employment has risen to 12% and that they have nearly 2,000 ongoing clinical trials in Massachusetts with major companies like Novartis, Genzyme, Bristol just to name a few. Is your company experiencing the same growth during this time of recession?
The rest of the post highlights their huge success in 2008, showing that their annual growth rate in employment has risen to 12% and that they have nearly 2,000 ongoing clinical trials in Massachusetts with major companies like Novartis, Genzyme, Bristol just to name a few. Is your company experiencing the same growth during this time of recession?
Tuesday, January 13, 2009
More Clinical Trials are Out of Compliance
Medical Product Outsourcing reports that the violation rate for clinical trial sponsors have gone up for the fiscal year of 2007, which has hit a 10 year high says the U.S. Food and Drug Administration.
Thirty three percent of the 40 clinical trial sponsors inspected by the center’s division of bioresearch monitoring were found to have some sort of regulatory violation, as opposed to 11 percent of 53 sponsors who were out of compliance the previous year. 2006 proved to be the best performance the industry had seen in 10 years. Can we expect 2008 numbers to produce similar results?
Thirty three percent of the 40 clinical trial sponsors inspected by the center’s division of bioresearch monitoring were found to have some sort of regulatory violation, as opposed to 11 percent of 53 sponsors who were out of compliance the previous year. 2006 proved to be the best performance the industry had seen in 10 years. Can we expect 2008 numbers to produce similar results?
Thursday, January 8, 2009
Patient Recruitment through Social Media
Yesterday, we posted that patient recruitment is a huge factor that causes biotechnology companies to run years behind on their timelines. Shahid Shah’s latest post on The Healthcare IT Guy discusses an easier, less expensive and time-saving alternate approach to traditional patient recruitment practices.
We’ve all heard of web 2.0 and social media by this time, but who would have known that patient recruitment could be done through social networking platforms. TrialX, which is a healthcare IT startup, has done a great job of using Google’s and Microsoft’s health platforms available to match participants to relevant clinical trials based on their personal health information. I look forward to when TrialX will completely integrate with Microsoft Health Vault and Google Health making it even easier for patients and investigators to find each other.
This trend will interesting to see as more and more healthcare companies being adopting web 2.0 patient recruitment methods in their practices.
We’ve all heard of web 2.0 and social media by this time, but who would have known that patient recruitment could be done through social networking platforms. TrialX, which is a healthcare IT startup, has done a great job of using Google’s and Microsoft’s health platforms available to match participants to relevant clinical trials based on their personal health information. I look forward to when TrialX will completely integrate with Microsoft Health Vault and Google Health making it even easier for patients and investigators to find each other.
This trend will interesting to see as more and more healthcare companies being adopting web 2.0 patient recruitment methods in their practices.
Friday, January 2, 2009
Covance Names Three New Senior Executives
According to this article in Clinical Trials Today, Covance has added three new senior executive positions to its services team. Covance has appointed Glynis Neagle, M.D., vice president for medical affairs; Robert Bader, director for product safety services; and Thomas Noto, vice president for regulatory affairs.
All three have over 15 years of experience in the clinical trials industry. It will be exciting to see what changes that they will bring to the table.
Wednesday, December 24, 2008
Happy Holidays from CTC
We will be taking some much needed time off for the holidays. We'd like to thank you for your readership and we encourage you to check back with us next year for more innovative thought, perspective and news surrounding the world of clinical trials.
We wish you a joyous holiday season!
Tuesday, December 23, 2008
Hard times leads to more patients for clinical trials
A recent news report from ABC 15 in Phoenix, Arizona reports that the current recession is leading more people to enroll as patients in clinical trials. Patients see this not only as a way to supplement their income, but also as a way to help perfect drugs that could be vital in future of their children.
Friday, December 19, 2008
Site Activation is Key for Successful Clinical Trials
PharmaExec.com has a informative article on its site that explains in full detail how site activation can improve and make way for successful clinical trials. Take a couple of minutes to read it, it’s worth it!
Wednesday, December 17, 2008
Setting up Successful Meetings for Clinical Trials Investigators
According to this article on ClinicalTrialsToday, participation from investors in global clinical trials conducted in the Central and Eastern European region was up 25% over the prior year’s. A reason why this is happening is because there has been a slight change in setting up investigator meetings.
One aspect is that meetings should be set in “nice” locations outside of Eastern Europe. Investigators from Eastern Europe like to travel and so that would produce higher numbers. Also, give the investigators some time for sightseeing as they rarely step foot outside of the office. This will take away the bitter feelings of having to sit within four walls and then return home immediately. Take a look at the article to see the rest of the aspects highlighted.
One aspect is that meetings should be set in “nice” locations outside of Eastern Europe. Investigators from Eastern Europe like to travel and so that would produce higher numbers. Also, give the investigators some time for sightseeing as they rarely step foot outside of the office. This will take away the bitter feelings of having to sit within four walls and then return home immediately. Take a look at the article to see the rest of the aspects highlighted.
Monday, December 15, 2008
Free Webinar: Project Management in the Life Sciences
Don’t miss your chance to view the free webinar Project Management in the Life Sciences: Results from a 2008 Survey and Comparison with Previous Surveys over the Last Decade with presenter Jann Nielsen on Wednesday January 22nd from 2:00 PM – 3:00 PM Est. Here’s a brief description of the webinar:
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.
- How project management occurs in large pharma, small pharma, and biotech
- Differences in how project management is performed in the US, EU and Canada
- Contrasts between virtual and defined project management group’s practices
- Comparisons between single and multiple function project management practices
Register here:
https://www1.gotomeeting.com/register/403770168
Mention priority code: G1M2140W1BLOG
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.
- How project management occurs in large pharma, small pharma, and biotech
- Differences in how project management is performed in the US, EU and Canada
- Contrasts between virtual and defined project management group’s practices
- Comparisons between single and multiple function project management practices
Register here:
https://www1.gotomeeting.com/register/403770168
Mention priority code: G1M2140W1BLOG
Friday, December 12, 2008
Clinical Trials and Unfavorable Results
Wednesday, December 10, 2008
Ex-Lilly executives open 'trials' clinic
From Applied Clinical Trials Online:
A new clinic that is on the cusp of conducting human trials in Indianapolis could distinguish itself as a key player in drug development, not only within the state, but nationally as well.Centurion Clinical Research LLC serves pharmaceutical companies and medical-device makers that need to test their products before they can be approved for widespread use. That first phase, in which healthy people are paid to participate in the overnight studies, is critical in determining the safety and success of a treatment.
"Without people volunteering, there won't be cures for these diseases," Centurion CEO William McGinnis said.
McGinnis and company President Michael Smiricky, both former Eli Lilly and Co. executives, are part of a group of 10 investors who raised more than $2 million to launch Centurion. It is the only commercial clinic in the city and just the second in the state that hosts Phase I trials.
For the rest of the article, click here.
A new clinic that is on the cusp of conducting human trials in Indianapolis could distinguish itself as a key player in drug development, not only within the state, but nationally as well.Centurion Clinical Research LLC serves pharmaceutical companies and medical-device makers that need to test their products before they can be approved for widespread use. That first phase, in which healthy people are paid to participate in the overnight studies, is critical in determining the safety and success of a treatment.
"Without people volunteering, there won't be cures for these diseases," Centurion CEO William McGinnis said.
McGinnis and company President Michael Smiricky, both former Eli Lilly and Co. executives, are part of a group of 10 investors who raised more than $2 million to launch Centurion. It is the only commercial clinic in the city and just the second in the state that hosts Phase I trials.
For the rest of the article, click here.
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