TrialTracker deployment on the Cloud

By Highton Gordon -Development Director

TrialTracker IXICO’s image management tool is trying to be a chameleon. Changing colour to suit it's environment and blending seamlessly in. Not the Jungles of Africa or Madagascar but the IT jungles of server rooms and data centers or preferred suppliers and ingrained relationships. Management of IT systems is a jungle, a growing cost for most companies and an administrative nightmare. As TrialTracker moves into this domain we want it to fit in seamlessly with whatever infrastructure and expertise the partner company already has. Administration of TrialTracker should not be a barrier to adoption.

With this goal in mind the architecture has been kept as technology neutral as possible. The servers should run on any flavor of Linux (or Unix) and have been tested on Ubuntu. The development language is Java. The database is any SQL92 compatible RDBMS - tested on PostgreSQL. Any servlet 2.5 container will work - tested with Apache Tomcat.

So for academic groups they can use TrialTracker on OpenSource infrastructure. For commercial use it can be validated on an infrastructure that matches the current company standards. For example if the company is an 'IBM' house then they could use AIX O/S, a WebSphere Servlet Container and the DB2 database. Obviously this type of deployment requires a validation step before it can be used - but there should be no code changes needed.

Why the cloud?

Well, the industry is heading that way. It builds on the flexibility that virtualization starts. The concepts have inherent value on their own. The concept can be applied on both internally or external hosted sites giving users even more conttrol. Organizations like Amazon are making the Cloud a product offering in it's own right. A very flexible and affordable product offering that piggybacks on the huge infrastructure investment they have made to support their core business. They do good web!

The cloud allows you the flexibility to grow and shrink your IT infrastructure as business needs, without:

- long lead times

- contractual agreements

- large capital investment

The cloud allows us to test on different operating systems and switch between them quickly without having to double up our test hardware.

Finally - it provides (almost) universal access across the globe. We did recently encounter a problem trying to access the Amazon Cloud from within the great firewall of China :-(

Administering systems on the cloud

(AKA driving from the back seat - 4000 miles away)

We have tried the On-Demand and the Dedicated hosts. Both are relatively simple to administer. A virtualized host image (AMI or Amazon Machine Image in the Amazon experience) is first created with the preferred operating system, support systems and the application (TrialTracker in our case). Once this image is created and named it can be started and stopped as needed. Multiple instances of this image can be started in parallel. Access to hosts on the Amazon cloud is through SSH (with a gpg key for security). Administration of the AMI can be done through Amazon Console or through a Firefox plug-in (ElastiFox)

Some gotcha's with the on-demand service

- Every time you start an on-demand instance - it is given a new IP address.
- When you shutdown an on-demand instance any volatile data is lost. It will restart in exactly the same state each time.

If you run an On-demand host, your application will need to be 'Cloud aware' and not sensitive to these limitations.
If you go for a dedicated hosts then no such problems occur.


We have deployed on Amazons US data centre - this allows us to test performance across the pond, plus it's good to spend US$....everyone wins!

Training MRI technologists in China

by David M. Cash,
Director of Medical Imaging

"Nihao from Beijing! I've been over in China the past week visiting hospitals and training MRI technologists on how to perform scanning for Alzheimer's Disease clinical trials. When I first heard that I would be going to China, I must admit to some trepidation. First of all, I've never traveled to Asia before. As a result, the irrational side of me was over-preparing for culture shock and home sickness. I was worried about getting lost, not speaking the language, and committing some cultural gaffe that would transmute into an international incident. One thing that helped alleve my concerns was that I would have my colleague Dr. Mingxing Hu, accompanying me on this journey. Mingxing has become a medical imaging expert, working on research in both English and Chinese centres. He also is a native Mandarin speaker and lived in Beijing for 6 years, so he knew the city pretty well.

When I first arrived Beijing I was blown away by the sheer size of the city, with skyscrapers soaring upwards for miles and miles. The immensity of the city and it's rapid growth could also be an appropriate metaphor for the problem of Alzheimer's Disease in China. According to the landmark research by the 10/66 group, China has the most AD cases of any nation, an estimated 5.0 million out of 24.3 million cases worldwide. By 2040, their estimates have this number rising over 300% to 26.1 million (of 81 million worldwide), primarily due to the nation's ageing population. Some estimate, China will be have half of all cases by 2050. At the same time, as the family size is shrinking in China, there will be fewer family members to serve as caregivers when their loved ones become ill.

Another thing that becomes very obvious is the crackling and fast pace of the city, primarily by watching the traffic as you nervously stick your toe out in an attempt to cross the street. Our first training session with the MRI technologists reflected this energy, as technologists beyond Beijing, from Xi'an to Shanghai to Guanzhou quickly absorbed the information through translators and returned with thoughtful questions about our methods. Many of them seemed very excited to be working on this trial. At the same time, we felt their concern as well, because they wanted to prove that Chinese sites could also participate in an increasingly global effort to find suitable biomarkers of prediction and disease modification for this disease, spearheaded by the Worldwide Alzheimer's Disease Neuroimaging Initiative (WW-ADNI).

While here, we also had the opportunity to visit a few hospitals around Beijing. Again, in planning for this trip, I had some challenges that I needed answers to. Would the sites have modern equipment and workflows in terms of acquiring, moving, and archiving data. Would any data protection laws or regulations make it difficult to get the data to us? DICOM supports Chinese characters, but how far did that support go? Did the main scanners support this feature? Would our systems be able to read the data?

Most of these issues disappeared within a few minutes of each visit. As with every other Chinese host I have had during this trip, the site staff was most hospitable, opening up their facilities to us and answering any questions we had. All the sites had pretty modern equipment (with a fair amount of 3T scanners), including their PACS. Mingxing was there to help assure the site staff and discuss more about the technical details. However, there was also a universal language or MRI and DICOM, which made it easier to discuss sequences, parameters, and file formats.

There will still be a few challenges. My jokes during the training didn't work through translation, but then they don't normally work in English either. Some sites may find it difficult to find 30 minute blocks to scan patients with a full safety and volumetic imaging protocol, as they currently work incredibly hard, operating the scanner 12 hours a day and usually can provide only 10-15 minutes for slots. The external network infrastructure of the imaging sites is less developed than in some other parts of the world. Overall, these challenges seem trivial amidst all of the potential here of acquiring data that could be critical for future AD trials."

David M. Cash, Ph. D.
Director of Medical Imaging

The MICCAI conference 2009

Earlier this week, IXICO was exhibiting at the MICCAI conference in London. This is an international conference to do with the analysis of medical images – with lots of really mathematical stuff presented by computer scientists and engineers. MICCAI stands for Medical Image Computing and Computer Assisted Interventions, so as well as analysis of images, it also has presentations on robotics. The people presenting at the MICCAI meeting are trying to invent new ways of using images to diagnose disease, plan treatment, monitor treatment progress or even control robotic surgery. If you get your work accepted at MICCAI you are doing very well, as less than 10% of work submitted is accepted for a talk.

MICCAI this year was in London, and two of IXICO’s founders – Dave Hawkes and Daniel Rueckert – were involved in organizing it. One of IXICO’s software developers – Sergiy Milko– was also presenting his work.

The people coming to MICCAI all use medical images in their research, and so all have to deal with the problem of moving around these images, collecting them from scanners, ensuring patient privacy rules are obeyed, and sharing the images with colleagues. All too often, the medical images used in this sort of research are not very well looked after – and get lost or mis-placed. If you don’t know what sort of patient the images are collected from, then they become useless for almost all types of research.

That is one reason we decided that MICCAI would be a good place to show everyone Trial Wire - http://www.mytrialwire.com/ – our free tool to share, de-identify and organize your DICOM medical images, and also show people Trial Tracker – our latest product that provides a web-based image management system for comprehensive management of all imaging data from acquisition to analysis. You can get more information on Trial Tracker here www.ixico.com/newproducts/trialtracker

And I nearly forgot – a real highlight of MICCAI was the conference dinner. It was held in the Science Museum. London’s science museum contains fascinating material, from old steam engines to Apollo lander to CT scanners. On the computing side, it contains really ancient computer gizmos - Baggage’s mechanical computer from 150 years go, or the computer memory developed 50 years ago for the Manchester computer). You couldn’t do much image analysis on those systems: modern scanners can generate 1Gbyte of data per patient!

So it was among all these fascinating exhibits that the MICCAI banquet was held – with stilt walkers, jugglers, and a disco. Quite an event!
To find out more about MICCAI go to http://www.miccai.org/

A blog about the blogger

I first started to look for an intern to help out as part of the IXICO marketing team. To be perfectly honest, we were not hoping for too much: just someone who would benefit from the experience of working at a fast-paced company like IXICO. When I was introduced to Anthony Chao (the creator of the IXICO blog) through the Shell Step placement program I quickly realised that we were in for a bit of an experience ourselves.

Over the course of the eight weeks Anthony spent with us, he successfully managed to plan and execute the technology social media marketing strategy and increased traffic to our web site by more than 30%. In addition to a host of other successful projects, Anthony also started the IXICO blog as a way to develop IXICO's image in the industry as a thought leader and to generally increase IXICO’s presence on the web.

Due largely to its informative yet informal tone, the IXICO blog has been well received internally and externally. Going forward, our aim is to rotate the authorship of the blog to allow real company participation on a variety of topics, based on the different areas of expertise within our group. The blog will be a platform from which IXICO employees can voice their opinions on or insights into relevant areas of discussion. I am extremely excited about the possibilities and we are indebted to Anthony for his efforts in getting this off the ground.

The Shell Step scheme is a UK-based organisation that links together small- to medium-sized businesses and undergraduates. The recruitment process was easy, and the people at Shell Step were available throughout the internship to monitor progress.

In recognition for his achievements, Anthony won the Shell Step Regional Award for most enterprising student. He now will be representing his region and competing for the award for most enterprising student of South UK. The award ceremony will be held on the 22nd September in London. Good luck, Anthony!

Would we recommend having an intern? Absolutely! Not only is it great to see fresh new talent but it is good to give something back. We will definitely be considering the shell Step program next year. To find out more about the Shell Step program visit www.shellstep.org.uk

Kranti Parekh

Marketing Manager - IXICO. Ltd

HIPAA - The Hippocratic Oath for Techies

As technology proliferated into healthcare, especially in the radiological practice, privacy protection once again entered the limelight as new issues concerning electronic data have been raised. In the medical imaging industry alone, which is a small subset of the healthcare sector, IXICO can testify that vast numbers of medical images exist in electronic format for compact storage, easy maintenance and rapid retrieval.

However, the convenience of data access across networks extending far beyond clinical sites or hospitals means that the patient’s personal information is potentially at risk of becoming publicly available. For example, every level of image transfer presents a potential security threat: (i) the images could be accessed by unauthorized parties at the clinical site (confidentiality) (ii) during the image transfer, images could be intercepted and modified (integrity) (iii) the intended receiver of the images might not receive them (authentication).

To meet the demands of rapidly developing technology, the US instituted in 2003 the Health Insurance Portability and Accountability Act (HIPAA) in order to set and enforce the standards for protecting the privacy and security of healthcare data. Indeed, privacy protection in the healthcare sector has always been an important issue. One part of the Hippocratic Oath, penned more than two millennia ago, stated that ‘Whatever I see or hear, professionally or privately, which ought not to be divulged, I will keep secret and tell no one’. HIPAA can be seen as the equivalent of the Hippocratic Oath for anyone dealing with electronic medical data. Non-compliance with HIPAA regulations can have severe consequences, including heavy fines and potential prison time.

Patient privacy is clearly an area of increasing focus for both the healthcare and technology industries. The difficulty for medical practitioners and clinical trial sponsors alike is that compliance with the regulations is difficult to maintain; the regulations are often not clear in their application to new and emerging technologies and individuals are often faced with rather laborious routes to compliance. The goal is to simplify the process as much as possible through automation. Many medical technology companies, including IXICO, are developing tools to help comply with HIPAA regulations through computer-based automation. Promising technologies include data encryption, virtual private networks, data embedding, and audit trails. These tools will undoubtedly improve personal data security and may potentially provide the basis for updating the laws governing the practice of medicine in the modern medical arena.

DICOM – The Industry’s Equivalent of a .pdf File

The word DICOM has a certain buzz about it in the medical imaging community. A substantial part of IXICO’s business revolves around DICOM data analysis. However, despite the large amount of information available in DICOM format, we can testify from experience that it still remains hazy to many. Below is a short description that explains how DICOM came about and its relevance to the imaging community.

DICOM stands for Digital Imaging and Communications in Medicine. It was developed in the 1980s and eventually adopted by the medical imaging community to allow for ease of communication and data transfer. DICOM can be thought of as the medical imaging field’s equivalent of a .pdf file or the lingua franca for imaging systems.

The development of a universal industry standard was imperative as digital imaging began to be widely used. Although the 1980s saw the proliferation of magnetic resonance imaging and computed tomography, both of which allowed for an unparallel level of image detail, the emphasis is now on easy connectivity and seamless communication between different imaging devices to boost efficiency and workflow.

The imaging devices were initially designed as isolated equipment with their unique printing and archiving methods. Equipment vendors were thus free to use their own propriety formats for storing imaging data. An image from one vendor could not be viewed using another’s viewer. Adding to this, it came to the point that the vendors would alter formats such that images from older devices could not be read by newer ones. Slight changes in image formats made it a nightmare for display workstations as they were forced to accommodate each new format.

DICOM was born out of the need to develop an imaging standard that would simplify data transfer and archiving between the many vendors. The DICOM format is now a universal imaging standard that is compatible with different brands, modalities, and models of imaging devices. A DICOM committee of radiologists, imaging equipment manufacturers, and engineers are tasked with periodically producing technical guidelines regarding transfer between devices, archives, printers and display workstations. Major imaging equipment manufacturers are also encouraged to produce DICOM conformance statements for their equipment.

DICOM is now the industry standard for medical images. It has made things easier for devices to communicate, raised awareness for connectivity amongst consumers, immensely enhanced collaboration between manufacturers to improve their products, and had a dramatic impact on clinical workflows.

To go electronic or not to go electronic; that is the question.

With 1.6 billion internet users, even more widespread computer users, and the fact that electronic data capture (EDC) tools have now been available for over two decades, it came to me as a surprise to find out that the majority of clinical trials are still conducted using the primitive method of paper data collection and then computerizing them – a long and drawn-out process that is prone to error.

The sceptic within the industry would point out that EDC, despite being around for two decades, has failed to greatly improve the efficiency and accuracy of clinical data capture. Needless to say, this is due to the continued reliance on paper over complete computerization, caused in part by the misconception that electronic data is difficult to validate. If EDC is to take off, the entire process would need to be streamlined and integrated rather than continue an inherently inefficient element in electronic form.

Luckily for the medical imaging industry, there is no paper-based process to replace. From experience, it is safe to say that the use of radiographic films has significantly reduced over the last 10 years. They are instead being replaced by electronic images in the industry-standard DICOM format. However, one would have thought that with the advent of the internet, these electronic data would be transferred and shared electronically. Fuelled partly by the belief that internet transfer is insecure and in part by the lack of internet connection at some clinical sites, medical images traditionally have been burned onto CDs and then couriered off. This has in turn delayed quality checks and turnaround times for further image analysis.

P&G Pharmaceutical estimated that every extra day a drug remains in clinical studies costs the sponsor at least $600,000 in lost sales. For a blockbuster drug, the daily revenue lost could reach $8 million. It is therefore in the interest of clinical trial sponsors to support better electronic processes at the various phases of clinical development to achieve greater overall efficiency. In relation to medical imaging, a web-based image management system would potentially reduce transfer costs, accelerate turnaround times and provide access to data in real time. The electronic nature of medical images means less work is needed to change sponsor attitudes towards a more web-based process, backed by strong documentation of work being conducted under FDA guidelines.