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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 11:34:11 PM
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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 06:05:14 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 09:30:52 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 11:25:55 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 11:25:41 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 08:47:46 PM
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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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Looking forward to DIA 2010
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Posted by
Elena Logan, 6/1/2010 10:19:14 AM
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 We’re gearing up for DIA again in a few weeks! We always look forward to being a part of the conference to shake familiar and new hands, learn from other industry leaders and reinforce our expanding central lab services.
It is definitely worth a trip to booth #1304 to find out more about our latest developments.
We want to show off our updated LabStar data management system for real-time access to test data. It now fully supports the CDISC Laboratory Model standard and provides many on-demand reporting options. We are now finalizing the online demo so you can see for yourself. Stay tuned for the link . . .
And of course, we will have copies of our most recent Clinical Insight, The Pathologist’s Role in the Diagnosis and Management of Disease.
But the most exciting part is our ACM Global Lottery draw for a chance to win an iPod Touch! You can try your luck at guessing the winning numbers at our booth. We will have lottery cards for you to fill out or you can download it here and bring it to the show. There will be a daily winner, which we’ll be announcing via Facebook, Twitter (watch for #dia2010), LinkedIn and this Blog.
We’ll post more details on these sites leading up to the conference, so become a fan or follower! 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 09:32:25 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 09:33:41 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 03:39:01 PM
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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 04:00:45 PM
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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 04:03:47 PM
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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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Leveling the Playing Field
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Posted by
Elena Logan, 2/8/2010 03:39:34 PM
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 It was with great pleasure that I participated in the Logistics Task Force panel at Central Labs West with Peter Colbourne of ConcentRx. What made this panel different was that we actually discussed how to resolve logistics issues, rather than just debating them. Plus it lasted for four hours because of the level of interactivity between panelists and the audience!
We focused on identifying the challenges associated with transportations of specimens including, costs, financial management, specimen integrity, and beyond. Sponsors, couriers and labs were all represented and what I found interesting was that not everyone was aware of the challenges from each group.
Sponsors want more details on how their dollars are spent – particularly when it comes to shipping since it can be upwards of 50% of the central lab budget. Traditional integrator couriers are battling for ground with specialty couriers. And central labs spend a lot of time managing all these couriers and their thousands of shipments each month.
Two main approaches were clear: The need for transparency and for better financial management throughout the life of a clinical trial. Obviously, these go hand-in-hand in helping control, or at least communicate, the transportation costs of specimens. Read more >>
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Category:
Logistics
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Welcome to our Central Labs in Focus Blog
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Posted by
Elena Logan, 2/1/2010 03:39:49 PM
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We recently celebrated our 10th Anniversary of providing stellar central lab services to the global drug development market and have experienced so many changes along the way. For example, we have seen the central lab market evolve into a truly global provider of clinical trial lab testing. It is an industry that was most recently valued at more than $1.5 billion a year by BioPharm Knowledge Publishing.
We feel that central labs will continue to develop core competencies in the growing complexity of central lab services in a very dynamic environment . So we launched this blog to draw attention to the challenges, issues, changes and trends of central lab services, in the hope of starting discussions that will bring forth insights into these topics and relevant concerns.
You can read more about our featured bloggers here and visit our website for more information on ACM Global Central Lab. We will update the blog often and encourage comments to provide a new perspective and advance the conversation.
So you don’t miss the latest posts, you always have the option to subscribe to get our posts delivered directly to you.
Read more >>
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Category:
Global Clinical Trials
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