Robert Carlson
At ACM Global, we have embraced innovative technology as a way to deliver cutting-edge lab research and testing services worldwide. We realize to maintain this excellence, we must examine the future of pathology—especially as we face a critical shortage of pathologists in the coming years.  In our most recent Clinical Insight, I examine the emergence of digitized pathology—which until recently was used only for consultation and/or consensus opinions in the United States and not for primary diagnosis.

But now the FDA has granted regulatory clearance of the first whole slide imaging (WSI) system for digital pathology for primary diagnostic use in the United States, allowing the review and interpretation of digital surgical pathology slides prepared from biopsied tissue. I evaluate the benefits and opportunities for central laboratories and how digitized pathology supports highly targeted therapeutics and precision medicine even further.

In addition, regulatory support for digital pathology systems continues to gain traction and may signal a shift in the industry’s readiness to consider uses beyond just consultation. This is especially true as having access to enough
Beverley Riley

ACM Global Central Laboratory is committed to delivering leading edge, and superior quality laboratory services for allergen testing in clinical trials. Since the discovery of IgE as an immunoglobulin isotype and the development of assays for total IgE and allergen-specific IgE, testing has relied on immunoassay technology. This technology has therefore become intimately linked to finding allergy treatments. In a recent Clinical Insight, I explore the modern science and technology available for allergen testing and the specific benefits they provide to clinical trials.
Central laboratories have a range of options even within just the fluoroenzymeimmunoassay systems. This technology is based on a sandwich principle where specific immunoglobulin, typically IgE binds to allergen linked to a solid phase polymer. Any bound complex is incubated with a developing agent that allows for measurement of specific immunoglobulin present.
For decades specific IgE evaluation used crude natural allergen extracts. Today there are an increasing number of molecular allergen components available, which has advanced the information available from the measurement of IgE and other
Gita Ramachandran

ACM Global’s success and growth in managing global clinical trials has recently required us to make a big change. I am thrilled to share that we have officially expanded our presence in the US with a brand-new facility.
Located in the Rochester Technical Park (RTP), and one mile away from our US headquarters in Elmgrove Park, our new facility represents an investment in our long-term success by our parent company Rochester Regional Health. It also enhances our ability to continue to meet the needs of our clients with high-quality laboratory services.
The facility boasts 10,000 square feet of office space with additional capacity for future expansion. This venue will accommodate the growth of our office staff and clinical operations, while allowing us to achieve new levels of operational control and efficiencies. Certain components of our laboratory operations, including QA and Scientific Affairs, specimen management and specimen storage, will remain at our Elmgrove Park location, making it convenient to travel back and forth.
The new office is located 158 Wallace Way, Building 9 in RTP.
Paul Skelding
Data management within the central laboratory field is currently undergoing an identity crisis. Data management groups across today’s industry are facing challenges in adding more value to the information they produce. This is the final installment of a three-part series that examines the evolving role of the modern data manager. 

Data governance is also a current trend within data management among central labs. The dissolution of the Safe Harbour agreement and the limbo period we currently find ourselves in show the balancing act we currently face for data ethics and information transfer consent. As many companies are scrambling to get a model clause agreement in place to enable the data transmission across the Atlantic, the thoughts of data governance are beginning to expand across all central lab data. 

In today’s clinical trials, clinical data solely belongs to the CRO or pharma company running the trial. We can run data trend recognition across the data sets for a CRO or sponsor, but only on their data. The trends we can see, which highlight site error rates, country-wide collection rates and time from enrollment to first visit are helpful for the current

Paul Skelding
Data management within the central laboratory field is currently undergoing an identity crisis. Data management groups across today’s industry are facing challenges in adding more value to the information they produce. This is the second installment of a three-part series that examines the evolving role of the modern data manager.

The term big data has been defined as a collection of data sets so large and complex that it becomes difficult to process using on-hand database management tools or traditional data processing applications. For the pharma industry, big data has become a focal point, and it is currently considered a must-have tool for data management.

In order for big data to be effective, pharma companies, CROs and central labs must all speak the same language. For example, whole genome scans produce big data, and managing terabytes or petabytes of data requires large network storage, high memory levels, fast CPUs, and clustered frameworks. Queries using this data must be carefully thought out, and newer software packages, such as Hadoop and Rapidminer, must be rolled out.

Big data is most useful for central labs when it can be interpreted into trends. The   
Paul Skelding
Data management within the central laboratory field is currently undergoing an identity crisis. Data management groups across today’s industry are facing challenges in adding more value to the information they produce. This is the first installment of a three-part series that examines the evolving role of the modern data manager.
Gone are the days that a central lab simply uses its data managers to transform data from one database format to another with a core level of quality control measures; a simple check of duplicates, a brief calculation of reference range outliers or a base check of pregnancy versus gender is no longer acceptable. It is clear that central labs now need to be at the forefront of data quality. 

However, many believe that simply integrating the central lab with the database will suffice, but the reality is that a central lab that simply presents the data requested has failed in its duty. Central lab data management groups need to be leveraged to highlight patterns in an expedited timeframe, which adds value to data and ultimately assists in clinical trial decision making. This enables key milestones to be reached more smoothly than the current
Kelli Isaacs
Last month, I was invited to speak at the Clinical Trial Budgeting & Forecasting 2016 conference to educate attendees on the importance of considering the central lab during protocol development. Central labs are often an afterthought in putting together a study budget, even though they provide the data that drives decision making on product development.

I would like to change that.

When central labs are included in the protocol development process, they can help determine appropriate testing based on the desired endpoints of the study.

My presentation from the event provides an outline of the process ACM Global uses to accurately project the central lab budget. It includes our proposal checklist, which emphasizes how key information from the RFP can help build an accurate and cost-effective budget.

You can download my slides here.

The real takeaway from the presentation is to always remember to help your central lab help you. We are able to provide you with direct access to seasoned experts who can help you develop an accurate proposal that aligns with your desired outcomes, from start to finish.   
Mark Engelhart

I recently sat down with Dan Limbach, host and producer of the PharmaVOICE Webcast Network, to record a podcast about the evolving role central labs play in optimizing clinical trials. Dan interviewed me about the steps biopharmaceutical companies and clinical research organizations should be taking to strategically drive efficiencies, and the real takeaway from the session is how an outcomes-based approach can prevent protocol amendments and minimize costly delays.

At ACM Global Central Laboratory, we have developed the Smarter Testing approach, which encourages collaboration with central labs during protocol development in order to match clinical diagnostic endpoints to desired study outcomes. During my conversation with Dan, I specify the “Smarter” steps organizations can take in order to significantly reduce study costs, complexity and risk. I also share the positive impact they can have on the safety and well-being of patients.

You are encouraged to listen to the full conversation in this PharmaVOICE podcast or download the transcript here.

To learn more about Smarter Testing, including the 6 Principles for Optimizing Test Selection, download a free copy   
Desa Rae Pastore

Season’s greetings from all of us at ACM Global! We would like to wish a happy holiday season and a healthy New Year to you and yours.

Because our global operations extend across more than 60 countries through our interconnected lab network, we thought it would be important to share the dates that our facilities will be closed not only for the 2015 holiday season, but throughout the upcoming year and beyond. Government-regulated holidays vary from one region to the next, so we have created a dedicated resource page on our website that displays all dates that ACM Global facilities will not be operating in the US, UK, India, Singapore, and China using easy-to-read charts. 
To view our full holiday schedule, simply visit the Global Logistics Holidays page of the ACM Global site. Select the appropriate region or regions to see the specific dates that local facilities will not be in operation. Note that each holiday is also accompanied by a timeframe during which ACM Global will not be shipping or collecting specimens.
If you have any questions or concerns, please don’t hesitate to contact us here.
Thank you for working with us in
Mark Engelhart
September marks an important milestone for us, as it has officially been one year since the opening of our ACM Shanghai lab facility. This notable event was preceded by the first anniversary of ACM Singapore, which commenced operations in June 2014.  

The addition of ACM owned and operated laboratories in Shanghai and Singapore was the latest in a series of growth-driven investments made by ACM Global. The facilities are an extension of our operations in the United States, the United Kingdom and China, creating an established network of harmonized laboratories that produce a single database of test data for all global projects.

Although ACM Global has successfully worked with partner labs in Asia more than 15 years, these fully-operational labs have truly strengthened ACM Global’s expertise across the Asia-Pacific region. They offer broad menus of safety and specialty testing, including chemistry, hematology, urinalysis, and immunology testing, and support numerous clinical trials throughout Shanghai, Singapore and beyond with increased speed and efficiency.

Click here for more information about ACM Global’s capabilities in Asia and across the world.
Desa Rae Pastore
Here at ACM Global Central Laboratory, we work hard to provide the most accurate and efficient strategies regarding lab research and testing. In our most recent Clinical Insight, I analyze the best practices behind personalized pathology research, as well as the biggest challenges those clinicians face. 
As personalized medicine continues to show great promise in the field of preventative medicine and diagnosis, the need for central labs to perform pathological testing, rather than simply correlating results between multiple labs, has proven prime to the practice. Along with providing optimal therapeutic benefits to patients, personalized medicine can establish market subtypes that render fewer costs for development and diagnostic companies. This specialization will also require pathologists themselves to be well-versed in disease subspecialities, which will lead to higher awareness and levels of expected expertise. 
However, some challenges do emerge with this trend, including the need for tighter turnover of sample analyses and more complex considerations for the central labs in regard to sample collection. The necessity of globalizing the sample
Richard Cunningham
During the recent Xtalks webinar, “Implementing a Sound Logistical Strategy to Mitigate Risk and Streamline Clinical Testing Across Global Clinical Trials - A Central Laboratory Perspective,” I outlined several key considerations for conducting clinical testing in challenging locations across the world and explained how 3P logistics principles (people, processes, and plans) play an increasingly important role in helping navigate the complicated logistics of managing specimens during global trials.

Attendees were also invited to submit their questions on mitigating risk across global clinical trials, and I was able to provide the following insights during the live Q&A:
How do you handle the export of blood samples from China involved in a clinical trial? Is it forbidden? 
It’s actually a common misconception that you cannot export blood samples in clinical trials. More focus should be given to the authorization to export, rather than the physical shipment itself. Getting this authorization to do so requires permission from the state drug approval administration in China, and there are various applications that need to be filled
Mark Engelhart

I’m excited to introduce a brand new e-Book from ACM Global Central Laboratory entitled, “Using Smarter Testing Strategies to Optimize Clinical Protocol Development.” This complimentary e-book explores how using our Smarter Testing approach early in protocol development can help you optimize clinical trials, drive efficiencies, avoid potential protocol amendments, and minimize costly study delays. 
What is Smarter Testing?
Smarter Testing is a unique approach developed by ACM Global that optimizes clinical protocol development by compelling sponsors to collaborate with their central laboratories more effectively. With Smarter Testing, the central lab is not only considered a place where diagnostic tests are performed, but also a partner that can help you accelerate the path to drug development.
When taking the Smarter Testing approach, sponsors consult with experts well-versed in disease subspecialties early in the protocol development process in order to select the right test that will ultimately achieve the desired data outcomes. By leveraging your central lab’s expertise in testing and interpretation early on, you can gain
Richard Cunningham
When it comes to clinical testing, navigating the complexities associated with global trials is no simple task. For example, managing specimen logistics often poses an array of challenges, with regulations regarding the shipment of temperature-critical specimens varying from one country to the next. For this reason, a central lab's expertise is becoming an increasingly instrumental asset to help manage such clinical trial logistics more seamlessly.
By actively collaborating with a central lab on the 3P logistics principles of clinical testing–the plan, the process and the people –sponsors gain an invaluable partner that minimizes risk and also improves the operational efficiencies of the trial. Central labs have more comprehensive insight in identifying a specific country’s regulatory framework for ensuring specimen integrity, which is especially beneficial to sponsors as they conduct trials in more heavily regulated regions. 

Next Thursday, May 7th, we’ll offer an exclusive opportunity for you to gain a more comprehensive understanding of 3P logistics principles and how they can help you more easily navigate the complicated logistics
Suzanne Dale
In a new Clinical Insight, I address factors that have recently posed several challenges in the development of antibiotics. Since the early 2000s, there has been a growing prevalence and spread of multidrug resistant organisms. Antibiotics for these organisms are not only more difficult to develop than other drugs, but the FDA imposes stricter guidelines in ensuring efficacy, which ultimately delays the process and incurs greater costs.

Although the government is making new efforts to overcome these obstacles, such as the Generate Antibiotic Incentives Now (GAIN) act signed into law in 2012, it will be several years before the full impact can be realized. For these reasons, it is becoming increasingly crucial that central labs are able to develop robust capabilities to support new clinical trials.

A central lab offering comprehensive microbiology services can be in a strong position to generate and integrate the strongest possible safety and microbiology data set to support antibiotic trials. However, it is important to understand how the microbiology laboratory operates and how the data they generate differs compared to other laboratory services.

I take a closer look

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