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New Article & Presentation on Organ Safety in Clinical Trials
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Posted by
Dr Andrew Botham, 3/27/2013 12:47:46 PM
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 As the single most frequent cause of safety-related drug marketing withdrawals, drug-induced liver injury (DILI) can have a significant impact on drug development. ACM Global has continued to lead the way in raising awareness on this important topic and other forms of organ toxicity by providing drug developers with novel biomarker panels for organ safety testing.
At the end of last year, we expanded our clinical trials services to include a Drug-Induced Organ Toxicity (DIOT) Monitoring program, which rigorously follows the 2009 FDA Guidance for Industry on DILI. It focuses primarily on real-time detection and monitoring of elevated liver toxicity biomarkers, which signal potential DILI, and provides trending reports for any conventional biomarkers tested. As part of the program, we also offer other organ toxicity monitoring services including Drug-Induced Kidney Injury and Drug-Induced Bone Marrow Injury.
Last month, I presented "DILI to DIOT: The early detection of drug-induced organ toxicity. Is your trial asking the right questions?" at Informa’s New Dynamics of Biomarker Labs, Central Labs and ECG & Imaging Labs conference in London. My presentation explored key questions around how and why DILI is missed during clinical trials Read more >>
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Category:
Clinical Trials Testing
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Great turnout at our Grand Opening, Ribbon Cutting & “Navigating” Workshop in York, UK
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Posted by
Jerry Boxall, 1/21/2013 02:09:13 PM
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 To celebrate our expanded laboratory operations in Europe, we hosted a Grand Opening event and ribbon cutting ceremony on Jan. 17th at our new facilities in York, UK. We had more than 30 current and prospective clients, vendors and press attend this exciting event, which included a ribbon-cutting ceremony with the Mayor of York, Councillor Keith Hyman, guided tours of our new, state-of-the art facilities with our Head of R&D Dr. Andrew Botham, a workshop, and an evening networking reception.
As part of our commitment to helping our clients navigate the ever-changing landscape of clinical trials testing and delivering the highest-quality lab results, we also hosted the latest in our “Navigating Global Clinical Trials with Your Central Lab” workshop series. Industry experts from PSI Pharma Support Intl, Meso Scale Discovery, Randox, and TNT Express were there to share their perspectives on interactions between central and regional laboratories in managing clinical trials, advancements in biomarker multiplexing, including a comparison of current methodologies, and logistical strategies for global shipping. The workshop was followed by a Q&A discussion and then a networking reception with cocktails and hors d'oeuvres at our Canteen Read more >>
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Category:
Global Clinical Trials
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On the Move! New, State-of-the-art European Central Lab Facilities
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Posted by
Jerry Boxall, 1/14/2013 09:27:06 AM
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 We’re excited to share the news of our recent relocation in Europe! In November, we moved our European headquarters into a larger, state-of-the-art facility in York, UK. The new space features 14,500 square feet of laboratory and office space, nearly double the size of our previous location, and has been purpose-built to optimize our laboratory processes and accommodate our growing staff of data analysts, project managers and quality assurance specialists.
The move to a larger facility was prompted by demand for our clinical trials testing services in Europe, and will also serve other regions like South Africa and the Middle East. We continue to see significant growth in these regions and the new facility enables us to better meet your needs with high-quality laboratory services.
We would also like to invite you to visit our new facility on January 17th for our Grand Opening event. There's still time to reserve your space at the event at www.acmgloballab.com/EUgrandopening.
We are excited with the prospects offered by our new facility in continuing to meet customer needs for high quality laboratory services. If you have questions regarding the relocation, we encourage you to contact us or visit the FAQ on our website: Read more >>
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Category:
Clinical Trials Testing
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Answering your Questions on Drug-Induced Organ Toxicity (DIOT)
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Posted by
Mark Engelhart, 11/5/2012 10:30:25 AM
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 We had a great webinar session last week on presenting safety parameters for early detection of potential organ toxicity. Based on the participation level and types of questions, it was clear that this topic resonates throughout the clinical trials industry. We have highlighted some of the insightful responses Dr. Botham and Dr. Patru provided during the Q&A portion of the webinar:
Is there any guideline or defined limit of ALT/AST level beyond that there could be risk or safety issue?
Essentially it’s ATs 3x ULN (3 times the upper limit of normal). The FDA will ask how many were at 3x ULN in a study, and also 5 and 10x ULN. The main issue isn’t just one patient, but an increase in frequency between patients – that’s a real signal that there may be a risk of toxicity associated with that drug. We encourage you to access the FDA guidance document, which provides valuable information on these parameters.
What percentage of patients in the active group should have elevations in transaminases above 3x ULN to consider it as a signal for liver damage?
Unfortunately there’s not a clear answer for that because it depends entirely on the specific trial within the patient group
Read more >>
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Category:
Clinical Trials Testing
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Drug-Induced Organ Toxicity (DIOT): Do you know the signs?
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Posted by
Mark Engelhart, 10/9/2012 08:59:11 PM
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 During our patient safety workshop in San Francisco last March, we examined drug-induced liver injury (DILI), the most frequent reason for safety-related drug withdrawals. We had such a good response that we’ve decided to expand on the topic and include a broader, more global audience.
As part of our “Navigating Global Clinical Trials with your Central Lab” event series, we’ll be presenting a live webinar on October 17 th at 11am ET that discusses the best ways to incorporate and monitor safety parameters in clinical trials based upon early detection of potential organ toxicity.
While DILI tops the list of potential causes for drug candidates being discontinued, kidney and other organ toxicities are also of major concern, because they can have significant and serious impact when discovered in the post-marketing phase. ACM Global’s Head of R&D, Dr. Andrew Botham, our Medical Liaison on the Scientific Affairs team, Dr. Maria-Magdalena Petru and I will discuss the signs of drug-induced organ toxicity (DIOT) and offer proactive strategies for assessing a drug’s adverse effect on vital organs and differentiating true drug-related toxicity versus underlying patient etiologies Read more >>
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Category:
Clinical Trials Testing
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Travel the World with Us at DIA 2012
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Posted by
Tracy Hendershott, 6/21/2012 04:53:42 PM
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 We always look forward to connecting with existing colleagues and making new connections at the DIA Annual Meeting. It also gives us the opportunity to talk about what’s new at ACM Global. And we’ve been quite busy the first part of the year.
For starters, our newest addition to the ACM Global team, Mark Engelhart, will be attending the show. As our new Chief Commercial Officer, he will be on hand to discuss the latest trends in clinical research lab testing and how drug developers and CROs can increase efficiency with their central lab partner. His ViewPoints were recently featured in the latest issue of PharmaVOICE for a brief overview.
We’ve also issued our latest Clinical Insight report from our Scientific Affairs Medical Liaison Dr. Maria-Magdalena Patru on Biomarkers of Toxicity Panel in Clinical Trials. As we’ve noted previously, drug induced organ toxicity is a serious issue for drug developers and they are looking for more innovative ways for better and earlier detection. We have some very interesting developments in this area . . . stay tuned.
Although DIA has traditionally been a North American focused show, it has become increasingly global in its focus and attendance Read more >>
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Category:
Global Clinical Trials
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New Clinical Insight from our Scientific Affairs Team on Novel Detection of Organ Toxicity
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Posted by
Kathy Murray, 6/20/2012 05:15:24 PM
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In her report, she outlines what drug developers need to be aware of when it comes to the latest options for liver and kidney laboratory safety testing and the importance of testing a combination of novel, early predictive toxicity biomarkers with conventional tests. She also highlights new biomarker tests that are attracting attention because of their ability to identify organ toxicity as early as Phase I or Phase II of a clinical program.
Other highlights include:
- The characteristics of an ideal biomarker
- Safety biomarkers for drug-induced liver injury (DILI) and drug-induced acute kidney injury (DIAKI)
- How central labs play a role in enabling safer drugs while maintaining costs
We will soon be introducing a new service involving drug-induced organ toxicity (DIOT) surveillance, which is especially significant to our small and mid-size clients whose resources are mostly outsourcedRead more >>
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Category:
Clinical Trials Testing
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Proactive Management and Detection of Hepatotoxicity in Prevention of Drug Induced Liver Injury
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Posted by
Dr Andrew Botham, 4/19/2012 11:32:07 PM
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 It comes as some surprise to many working within clinical trials that drug-induced liver injury (DILI) is the single most frequent cause of safety-related drug marketing withdrawals today and has been for more than 50 years now. Yet despite this fact, there is still very little understanding within the drug community as to the monitoring that can be performed to identify the potential of DILI early on within a trial.
An incidence of ≤1 in 10,000 is enough for a drug to be withdrawn from the market, or have its market severely restricted. So it’s no surprise that in studies of just 1,000 to 3,000 patients, the danger is not overt and often missed.
I recently presented a series of guidelines at our inaugural workshop on “Ensuring Patient Safety through Efficient Specimen Lifecycle Management,” which outlined how realistic and achievable monitoring techniques can be used for the early identification of the potential for DILI.
Although most, if not all clinical trials perform testing and use flagging for development of hepatotoxicity (primarily using the aminotranferases; ATs), an increased incidence of hepatotoxicity may or may not be a signal of a potential for severe DILI
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Category:
Specimen Management
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Insightful Perspectives on Specimen Management Offered at Inaugural Patient Safety Workshop
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Posted by
Tracy Hendershott, 4/9/2012 04:12:17 PM
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 We recently hosted our first workshop in San Francisco and despite the rain, attendees from a variety of companies braved the weather to hear our expert speakers share their valuable insights on different perspectives pertaining to patient safety in clinical trials.
Our own Head of R&D Dr. Andrew Botham kicked off the afternoon with a presentation on some of the safety parameters for assessing a drug's effect on toxicity levels. As Andrew pointed out, Drug Induced Liver Injury (DILI) has been the single most frequent cause of safety-related drug marketing withdrawals for more than 50 years now! His presentation offered ways to improve patient safety by proactively managing and detecting hepatotoxicity.
Cryoport’s Larry Stambaugh spoke on the topic of global frozen shipping and offered new cold chain shipping innovations as a growing alternative to dry ice for maintaining specimen integrity during clinical trials testing. Until recently, the industry has relied almost exclusively on dry ice for frozen shipping, but as Larry pointed out, it has a number of limitations that should be evaluated before choosing it as a stand-alone option. New dry vapor shipping solutions are making their way onto the scene and offer a cost-effective and compliant alternative to dry ice Read more >>
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Category:
Specimen Management
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Ship Ahoy! New Article on Frozen Shipping Considerations for International Clinical Trials
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Posted by
Tracy Hendershott, 3/2/2012 02:57:33 PM
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 If you are current evaluating new shipping options for clinical trials specimens, I highly recommend the article, “Ship Ahoy,” that was published in the February 2012 issue of International Clinical Trials. Together with Larry Stambaugh of Cryoport, we explore the developments in recent cold chain technology that are aiding the growing number of trials around the globe.
We also discuss the host of logistical, regulatory and budgetary challenges associated with transporting temperature-sensitive samples and the increasingly vital role that central labs are playing in guiding sponsors through their shipping options to help maintain a high-quality standard, drive down costs and minimize risks within the cold chain. We also discuss the importance of partnering with a central lab that can provide shipping expertise and bring innovative and cost-effective solutions to the table.
At ACM Global Central Lab, we take complete ownership of managing transport logistics, from customizing each kit to comply with regulations governing the transportation of biological samples and performing quality control checks prior to dispatching them to investigator sites to choosing the courier service most appropriate for each investigator site to optimize cost and efficiency
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Category:
Logistics
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New Workshop Series – Navigating Global Clinical Trials with a Central Lab
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Posted by
Tracy Hendershott, 2/29/2012 02:33:32 PM
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We are excited to launch the first workshop in our series, “Navigating Global Clinical Trials with Your Central Lab.” Clinical trials testing remains our number one priority and we saw a need to deliver interactive workshops that would help biopharmaceutical companies and CROs navigate their way around some of the logistical and financial hurdles that pop up when transporting specimens for global trials.
Our first workshop is on “Ensuring Patient Safety through Efficient Specimen Lifecycle Management,” and will take place on March 15th in San Francisco at the Hotel Vitale. Our very own Dr. Andrew Botham, Head of R&D, will present our expertise and best practices around maintaining specimen integrity throughout the clinical trials testing process to ensure patient safety, while introducing some innovative approaches to balancing logistics costs. We’ll also provide the key to avoiding the single most frequent reason for safety-related drug withdrawal from the market.
We’ll be joined by our partners Cryoport and Dorevitch Pathology, who will share their expert insights safeguarding sample integrity. Cryoport CEO Larry Stambaugh will share cold chain shipping innovations to help maintain specimen integrity, while Dorevitch’s Clinical Trails Manager Robyn Wootton will offer operational best practices for handling and distributing low-volume specimens in Asia Pacific Read more >>
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Category:
Clinical Trials Testing
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Why You Need to Know More about Dry Vapor Shipping for Your Next Clinical Trial
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Posted by
Tracy Hendershott, 10/4/2011 10:54:51 PM
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I can’t tell you how excited we are to announce that we’ve validated a breakthrough technology with our partner Cryoport that promises to significantly lower your shipping costs. For those of you who aren’t familiar, Cryoport provides frozen shipping solutions for clinical labs, diagnostic companies, research organizations, biotech and pharmaceutical industries.
They’ve developed an innovative cold chain shipping solution that serves as an alternative to dry-ice packaging, therefore eliminating the costs associated with re-icing specimens during transit. Cryoport’s dry vapor shipper allows tissue samples, blood and other biological material to remain frozen at or below -150ºC for 10+ days!
We’ve been working with them for the past six months, assessing the movement and temperature profile on nearly 600 specimens, to confirm that its technology meets international regulatory compliance standards.
We are proud to announce that we’ve now moved into production mode and are offering this innovative cold chain shipping solution to our global customers.
Have you had experience with dry vapor shipping methods? Are you familiar with Cryoport Read more >>
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Category:
Logistics
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DIA 2011 Informs and Inspires
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Posted by
Tracy Hendershott, 7/12/2011 07:22:39 PM
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 Well, another DIA Annual Conference has come and gone, and like years past, this was quite an opportunity to participate in industry wide discussions, meet face to face with previous, existing and hopefully future clients, as well as always an opportunity to catch up with industry colleagues and friends that have been made over 20 years during my clinical trials career!
With the new format of reduced and combined tracks this year, and the addition of SAIC showcases, most individuals that I spoke with agreed with the changes and enjoyed the opportunity for a more focused session attendance experience. As usual though, not enough time in the day to fit all the sessions that one is interested in and I fully look forward to the opportunity to catch those I missed in the online DIA Live Learning Center.
A prominent theme at this year's conference had to be data interoperability, with multiple sessions dedicated to the topic, as well as a significant portion of the exhibition floor being dedicated to the jointly sponsored DIA-CDISC-IHE-HIMSS Interoperability Showcase.
With ACM being a longtime supporter of industry wide standards in general, and CDISC specifically, as well as our corporate ownership being held completely by Unity Health Systems, we all have a keen interest in bringing our process and documentation into the eClinical arena Read more >>
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Category:
Global Clinical Trials
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New Clinical Insight - Measurement of Cancer Biomarkers by Flow Cytometry and Molecular Technology
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Posted by
Kathy Murray, 12/13/2010 07:24:49 AM
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 I am delighted to present the latest instalment in our Clinical Insight series, which is written by Dr Hua-Kang Wu, ACM Global Central Lab’s Associate Director of Molecular and Cellular Diagnostics.
The article, entitled ‘Measurement of Cancer Biomarkers by Flow Cytometry and Molecular Technology’ will discuss:
- What are biomarkers and the role they play in clinical oncology
- How flow cytometry can be used to identify cancer biomarkers
- The benefits of using Luminex assays
- How molecular diagnostic techniques are used to assist the diagnosis and monitoring of many genetic, infectious and malignant forms of haematological disease and other types of cancer.
This Clinical Insight is available to download now from our website. We hope you find it an interesting and informative read, and welcome any thoughts or comments you have on this subject. At ACM Global Central Lab we also have a team of scientific and industry experts on hand to answer any questions, or discuss any testing requirements that you have.
We look forward to hearing from you! Read more >>
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Category:
Clinical Trials Testing
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Mixing with oncology specialists at ESMO 2010
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Posted by
Charlotte Perrin, 10/20/2010 08:15:47 AM
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Held in the cosmopolitan & commercial city of Milan, the 35th ESMO (European Society of Medical Oncology) congress drew representatives from all major pharmaceutical companies involved in oncology specialities. The well attended event provided the opportunity for medical oncology specialists to meet and the ideal forum to present and promote excellence in this highly important therapeutic area.
For ACM Global it was a great opportunity to meet with the main movers & shakers of the oncology arena and fully update ourselves on the current hot topics being discussed by academics and industry sponsors alike. Our Executive Director of Global Technical Affairs, Kathy Murray listened to some of the very interesting talks and discussions groups, including an afternoon of biomarkers. As this is an area ACM Global looks to expand into, it is vital we be aware of those which will be coming to the forefront and will be pivotal in upcoming clinical trials.
All in all, a good conference made better by the opportunity to experience Milan’s culture and most importantly pizza!! Read more >>
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Category:
Clinical Trials Testing
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Vendor staffing and personnel resourcing: securing the 'A team' for your clinical trial
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Posted by
Tracy Hendershott, 10/13/2010 02:27:52 AM
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I can't say enough positive things about the recent Outsourcing in Clinical Trials Northeast conference recently held in Framingham, MA. Arena Events put on a well run conference, with very informative presentations over both days. From speaking with attendees that were present last year as well, it seems as if participation in the conference, both in attendees as well as corporate sponsors, was almost double from the previous year, so I believe I'm not alone when attributing value to those two days. It was great to see some familiar faces, as well as to meet some of you in person for the first time!
On the first day, there was a lot of discussion from the sponsor perspective in regards to vendor staffing and personnel resourcing. Concerns were expressed about experiencing a bait and switch tactic from vendors by being promised their A team and ultimately being delivered a B team. Also statements were made from the sponsor perspective in regards to the most disruptive event to happen throughout study conduct, was changes in personnel. The point was made that in assigning contracts to vendors, in addition to capabilities, a critical decision point is the personnel Read more >>
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Category:
Global Clinical Trials
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New Clinical Insight: HLA-B27 Screening by Flow-Cytometry
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Posted by
Dr Andrew Botham, 9/22/2010 03:07:16 AM
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I am excited to present our latest Clinical Insight on HLA-B27 screening by flow-cytometry - available now to download from our website. ACM Global have recently added this to their in-house testing repertoire and due to the number of blank stares I have received when highlighting this I thought I would provide and brief background, and the significance of this testing.
The Human Leucocyte Antigen (or HLA) is the name of the Major Histocompatibility Complex in humans (MHC). HLA's are expressing on the surface of most cells and are essentially unique to that individual. HLA's are used by the immune system to differentiate self and non-self cells and when compromised. HLA-B27 is a sub-type of Class I HLA's and is responsible for presenting antigens to T-cells. The HLA-B27 is strongly associated with a certain set of automimmune conditions referred to as "Seronegative spondyloarthropathy", and I'll discuss why the relationship between different diseases and HLA-B27 is yet to be fully understood.
For those of you still unfamiliar with our Clinical Insight, we produce a series of technical reports, written by our team of experts on different issues affecting clinical testing today Read more >>
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Category:
Clinical Trials Testing
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Reporting in Action: New online LabStar Demo
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Posted by
Tracy Hendershott, 9/20/2010 03:13:10 AM
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 We've just launched a new online demo of our LabStar data management system to showcase how sponsors can easily access laboratory test results in a near real-time and secure fashion. Check it out - visit the LabStar demo link on our website for our "tour" of the system.
Created in-house, LabStar is an automated system designed specifically for clinical trial management and offers rapid and secure access to real-time test data, locally and globally - all through a web interface.
The interactive demo gives you the ability to select whatever component of LabStar's capabilities you want to learn about, from "Test Trending" to "Protocol Reports" - simply scroll through the subjects, and choose the desired tutorial. You can also take notes, and search topics/keywords via the search tab.
We'd love to hear what you think? Please leave any thoughts or comments below.
Alternatively join the conversation on our Facebook and Twitter pages, and check out our new LinkedIn Discussion Group. Read more >>
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Category:
Data Management
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What is Considered Basic Safety Testing these Days?
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Posted by
Kathy Murray, 8/23/2010 02:36:30 AM
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I want to open the discussion of what we now consider “basic safety testing.” With increasingly complex protocols and regulations comes an inevitable evolution in what we consider this term to mean. I’ll preface this discussion with a brief synopsis of obvious advancements I’ve seen, and would enjoy hearing about your observations over time in regards to this subject.
It used to be that performing the main concentrations of basic safety testing, bio-chemistry, hematology, coagulation and urinalysis testing encompassed industry standards to ensure no clinically significant variations from baseline were due to the pharmacodynamic of the study article.
However, ACM Global is now addressing the shifting focus to more esoteric exploratory essays. Protocols are now including more esoteric and molecular based assays. The use of our multiplexing instrumentation and increased utilization of flow cytometry is serving to address the evolving identification of biomarkers to aid in the treatment and tracking of disease progression. We are adding new markers to our test menu on a regular basis in response to this focus on esoteric biomarkers from our clinical trial clients Read more >>
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Category:
Clinical Trials Testing
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MHRA Guidance Document –What It Means for Central Labs and Why We’re Excited About It
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Posted by
Lorrie Divers, 7/13/2010 02:36:10 AM
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 This past January, our QA Officer in Europe, Elizabeth Atkin and I attended the MHRA conference – GCP for Clinical Laboratories – Clinical Pursuits in York, England – and we were thoroughly impressed with how organized, well run and educational the whole experience was. Sessions throughout the day provided comprehensive overviews of how the clinical trials regulations directly impact central clinical laboratories, and there were practical presentations and discussions on how such laboratories can effectively and efficiently operate in compliance with GCP requirements. Read more >>
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Category:
Quality Assurance
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Insight Into Using Labs for Increasing Operational Efficiencies
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Posted by
Steve Morley, 7/2/2010 02:35:59 AM
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This past week, I had the opportunity to speak at the Partnering with Central Labs, ECG and Imaging Labs Conference in Brussels, Belgium. I was asked to discuss the above mentioned subject, and also to provide insight into how Sponsors can work with central labs to optimise operational efficiency, yet still deliver the cost savings demanded by the industry. I would like to share with you not only the main points presented at the conference, but also, a selection of the questions that were raised in the discussion afterwards.
In the first part of my presentation, I referenced the Logistics Task Force discussions that were held in San Francisco earlier this year at the Central Labs West meeting. Several themes were evident, which I discussed in more detail during my presentation in Brussels.
Firstly, in dealing with operational logistics, Sponsors require justification of the fees, and are frustrated at the lack of transparency, particularly when it comes to the breakdown of transportation costs which can comprise approximately 50% of the central lab budget. Sponsors also require confidence that the initial central lab proposal is accurate, which can cause challenges Read more >>
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Category:
Logistics
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Notes to File – Problematic or Preventive?
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Posted by
Lorrie Divers, 6/21/2010 02:35:43 AM
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I recently had the privilege of speaking at the Roswell Park Cancer Institute's Education Day for Clinical Research Staff on a topic chosen by the staff: How to prepare for sponsor audits. The topic selection alone was an indication of how engaged their clinical research staff is, and their questions demonstrated their proactive approach to improve overall study quality.
For example, there was a question regarding notes to file (NTF) that led to an interesting discussion. NTF are typically used to explain any discrepancies or missing/incomplete data during the course of a trial and are increasingly requested by sponsor monitoring staff to provide additional information or clarification. This practice has become prevalent, and yet simultaneously problematic.
When used properly, NTF can be valuable source documentation. However, when they simply note a problem and don’t resolve it, these NTF can raise more questions than they answer for auditors and regulatory authority inspectors. For example, issues can arise when NTF are written long after the initial occurrence or corrective action was taken. (Carl Anderson of Biologics Consulting Group wrote a great article Read more >>
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Category:
Quality Assurance
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DIA 3rd Day: Packing up, announcing last winner, and happy to report an overall success
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Posted by
Kathy Murray, 6/16/2010 02:35:27 AM
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I always love going to conferences like DIA. Although we are all exhausted after a long three days here in D.C., our whole team is very pleased with what we are taking back with us. We reconnected with industry colleagues, met new contacts that were interested in our central lab services and new LabStar system, and learned new perspectives on outsourcing in clinical trials from the sessions.
While I attended the conference sessions, there was a whole other set of events happening on the exhibit floor. Our Lottery was once again a huge hit. We had a quite a large number of participants, and someone guessed the lucky numbers!
Congratulations to Maggy Li from Seattle Genetics for choosing our lotto numbers of 15 and 09. Like the other winners, Maggy received a brand new iPod Touch. Towards the end of the conference, people started to catch on to the trend of our lucky numbers, as they all represent numbers from our company that we are particularly proud of.
Wednesday’s numbers represent the following:
· We have 9 board certified pathologists on staff
· We have completed over 1500 studies
Remember that you can catch all activity from the conference at Read more >>
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Category:
Global Clinical Trials
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DIA 2nd Day: Energetic Exhibit Floor and Another Lottery Winner!
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Posted by
Kathy Murray, 6/15/2010 02:35:14 AM
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We are here at DIA for the second day now, and there continues to be lots of traffic on the floor, great speaking sessions and a lot of fun with our Lottery Campaign.
Congrats to Nancy Havrilla for guessing today’s lucky numbers. She walked away a very happy woman with her brand new iPod Touch. Remember that if you entered our lottery, you can see if you were a winner at Facebook.com/ACMGlobalLab or Twitter.com/ACMGlobalLab.
And the lucky numbers are . . . 13 and 60.If you’ve been by the booth, or seen our advertising campaign, you would know what those numbers represent (anyone starting to see a trend in the winning numbers?):
· We perform 13 million tests each year
· We have operations in 60 countries worldwide
We would love to hear about your experiences at DIA and anything you may have to say about the conference in general.
Keep on coming by our booth #1304! Our U.S. and European team members will be waiting for you. Also, don’t forget that tomorrow (Wednesday) is the last day to enter our Lottery. We will be announcing winners via Facebook, Twitter and here at our Blog daily Read more >>
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Category:
Global Clinical Trials
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DIA 1st Day: Highlights, Lottery Winner and Tips from Speaker Sessions
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Posted by
Kathy Murray, 6/14/2010 02:35:00 AM
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The DIA conference is officially underway, and we are excited to report that the first day was very positive. Overall, the energy is great, sessions are informative and helpful and many impressive booths are on display.
Our Lottery contest was also a huge hit! Many people participated and had fun in guessing the two lucky winning numbers of the day, in hopes to win an iPod Touch.
Monday’s two lucky numbers were 99 and 04. If you’ve been by the booth or seen our advertising campaign, you would know what those numbers represent:
· 99% of our customers say that they would recommend us
· Our staff turnover rate is only 4%
Congrats to Michelle Macan, Senior Contracts Manager at Forest Research Institute, Inc. for guessing these lucky numbers! She walked away today smiling with her brand new iPod Touch. You can view her winning picture and many others taken at the conference on Facebook.com/ACMGlobalLab or Twitter.com/ACMGlobalLab.
Read more >>
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Category:
Global Clinical Trials
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Evolution of Central Labs Series: “Maximizing Test Data Capture”
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Posted by
Kathy Murray, 5/19/2010 02:34:46 AM
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In continuation of our Evolution of Central Labs series, we examine how central labs are responding to sponsor’s ever-growing need to maximize test data capture with each patient during a clinical trial.
Biopharmaceutical sponsors are looking to maximize their investment in clinical trials by testing multiple hypotheses within a single protocol and therefore within a single patient. The advancements in science over the past decade enable sponsors to test very specific conditions within a protocol, which greatly increases the complexity of testing schedules and requires more esoteric tests.
With the goal of gathering more data from a single patient within the stated protocol, sponsors are more forward thinking about test data capture. Gathering enough specimens can provide a picture on how a drug will react in their target populations from several angles. For instance if multiple sclerosis patients express a novel exploratory biomarker during a trial, it may lead to a new focus for the drug discovery group leading to a new approach to treatment or cure and can eventually be introduced in the diagnostic setting.
Certainly, the constant changes in testing options and more complex protocols place central labs in a more pivotal role to affect the conduct of a trial Read more >>
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Category:
Clinical Trials Testing
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Evolution of Central Labs Series: “Hybrid Central Lab Model”
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Posted by
Tracy Hendershott, 4/26/2010 02:34:32 AM
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After celebrating 10 years of providing global central lab services, we wanted to present a blog series to highlight the changes we’ve experienced.
The first central lab was conceived in 1986, after industry experts realized the challenges assigned to acquiring data from multiple local laboratories with varied standard operating procedures, reference ranges, protocols and testing methodologies. Since the advent of this now billion dollar industry, there have been many challenges that are worthy of discussing.
We are beginning our blog series on the topic of, “Hybrid Central Lab Model” and look forward to your comments!
Historically, central labs initially partner with a regional lab when entering a foreign market until sufficient business warrants the investment to build its own lab facilities. This wholly owned central lab model provides advantages that include data integrity, homogenous data integration and functional controls. However, upon building a new, costly lab, disadvantages may include the need to outsource esoteric tests due to narrow depth of testing, limited regional expertise regarding logistics, and regulatory guidelines.
New operational hybrid approach allows sponsors to take advantage of established, regional central labs while benefitting from advanced data management systems for the centralization and harmonization of test data Read more >>
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Category:
Global Clinical Trials
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A QA Perspective on Working with New Clinical Research Sites
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Posted by
Lorrie Divers, 4/12/2010 02:34:15 AM
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How difficult is it to train and set up investigator sites that have never been involved in clinical research
This question was posed to myself and other members of the Clinical Research Professionals group on LinkedIn. Thorough Good Clinical Practices (GCP) training, careful consideration of the site's capabilities, personnel resources, and commitment from the principal investigator (PI) are all important. However, in my opinion there are several other factors also critically important for a successful naive clinical research site.
1) Practical training in managing the routine and non-routine tasks of conducting a clinical trial.
Much the process can be described in SOPs, however, for staff who has never conducted a clinical trial before, many of the things experienced personnel take for granted will be new and unknown. For example, they need to understand not only the importance of using the current, IRB-approved version of the informed consent form, but how to actually control the document to ensure that is done consistently and easily. They need to understand how to keep accurate investigational drug accountability records with periodical review the inventory, compare them to the accountability record and identify and investigate/correct any discrepancies in “real time” rather than 14 months later Read more >>
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Category:
Quality Assurance
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New Clinical Insight: The Pathologist’s Role in the Diagnosis and Management of Disease
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Posted by
Kathy Murray, 3/31/2010 02:33:56 AM
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Our latest Clinical Insight is a must read for anyone conducting clinical trials that analyze pathology tissue. Written in partnership with Dr. Xiaolan Ou, Dr. John D’Souza and myself,we discuss how tissue specimens are an essential component for the diagnosis and assessment response to treatment, especially in oncology studies.
Studies involving tissue pathology require accurate and standardized interpretations of specimens from similar areas, and are essential for the assessment of primary end points prior to submission of the test product for approval to the FDA. In this issue, we discuss:
We would certainly like to hear from you about your experiences of how pathologists have helped diagnose subjects for valid inclusion in a trial.
For those unfamiliar with our Clinical Insights, we produce a series of technical reports written by our team of experts on issues effecting clinical testing today Read more >>
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Category:
Clinical Trials Testing
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A True Collaboration – EDC & Central Labs
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Posted by
Chris Helton, 3/29/2010 02:33:42 AM
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Naturally our presentation centered on the emergence of standards and advances in technology. There has been significant progress in these areas, but we wanted to dive a little deeper to explore the opportunities for tighter integration between central labs and EDC systems.
This is becoming increasingly important for sponsors as CDISC estimates that the annual cost to the industry of laboratory data interchange alone is at least $150 million and that between 30% and 60% of that cost could be saved from the use of a standard. Furthermore, the consortium recognizes that the more significant benefit of a standardized data interchange is in terms of time savings in an industry with running costs estimated at $1 million per day!
We were not surprised by the results from the reader poll taken during the presentation. When asked “Do you plan on implementing and embracing the CDISC Lab standard in your organization in the near future Read more >>
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Category:
Data Management
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