The meeting focuses on China’s collaboration in the global innovation community. For the first time, SFDA’s Center for Drug Evaluation (CDE), has agreed to conduct a town hall meeting that will allow meeting participants to have an open and direct dialog with CDE. Additional collaborative opportunities are available with China’s SFDA, US FDA and US Department of Commerce. DATATRAK is pleased to join participants representing a wide range of professions – industry, government, academia, associations. Please see www.diachina.org for more information.

DATATRAK ONE™ is a comprehensive cloud-based global clinical research platform helping customers with the strategy, planning and management of their entire life science product portfolio, including resource management, study execution needs and safety reporting.

About DATATRAK

DATATRAK International is a worldwide technology and services company delivering eClinical solutions and related services for the clinical trials industry. DATATRAK built its multi-component, comprehensive solution on a single, unified platform and expanded this concept to include services delivery via DATATRAK’s Clinical and Consulting Services™ group. The Company delivers a complete portfolio of software products designed to accelerate the reporting of clinical research data from sites to sponsors and ultimately regulatory authorities, faster and more efficiently than loosely integrated technologies. The DATATRAK ONE™ software solution, deployed worldwide through an ASP or Enterprise Transfer offering, supports Phase I – Phase IV drug and devices studies in multiple languages throughout the world. DATATRAK has offices located in Cleveland, Ohio; Bryan, Texas; and Cary (RTP), North Carolina. For more information, visit www.datatrak.net.

Except for the historical information contained in this press release, the statements made in this release are forward-looking statements. These forward-looking statements are made based on management’s expectations, assumptions, estimates and current beliefs concerning the operations, future results and prospects of the Company and are subject to uncertainties and factors which are difficult to predict and, in many instances, are beyond the control of the Company, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. For a list of certain of the factors that may cause actual results to differ materially from those contemplated in these forward looking statements, please see the Company’s quarterly report filed with the OTCQX Market on May 10, 2012 announcing its results for the three-month period ending March 31, 2012. The Company undertakes no obligation to update publicly or revise any forward-looking statement whether as a result of new information, future events or otherwise.

Contact:

Lisa Pahl, Director Marketing, DATATRAK International, Inc., +1-979-393-9025

Dr. Bill Gluck, VP, Clinical and Consulting Services, spoke about CDM’s role in supporting risk-based monitoring at LifeScience Alley. The presentation discussed interactions between sponsors, clinical operations and CDM, risk-based challenges for industry sectors and the implementations affect on data quality and integrity.

CLEVELAND, May 9 /PRNewswire/ – DATATRAK International, Inc. (OTCQX: DATA), a technology and services company focused on global eClinical solutions for the clinical trials industry, today announced its operating results for the first quarter of 2012.

Highlights for the first quarter of 2012 include:

• Revenue increased 14% over the previous quarter to $2.1M; a 12% increase over the comparable quarter of the prior year
• Gross profit margin was 81%, despite increased headcount to support growth
• Backlog at the end of the quarter totaled $14 million; a 21% increase over the prior quarter and the highest balance in 6 years
• Cash balance at the end of the quarter increased 21% to $1.4 million compared to the comparable quarter of 2011
• Continued sales pipeline expansion
  – New contract sales increased 170% versus the first quarter of 2011
  – RPS, one of the industry’s largest contract research organizations (CRO), has standardized on DATATRAK ONE™
  – Expanded client base
        - 38% year-over-year increase in the number of clients
        - 233% year-over-year increase in clinical and consulting services clients
• Announced the release of the innovative new uCTMS™ product
• Celebrated the 10th year of medical coding services utilizing DATATRAK’s uEDC™ Coding Module
• Announced the release of a completely new product design for the randomization and clinical supplies management product, uIRT™
  – Closing in on the 10,000th randomized patient
• Participated in key global events
  – 21st Anniversary Partnerships in Clinical Trials
  – BIO-Europe 2012
  – CBI’s 5th Annual Forum on Clinical Trial Management
  – 24th Annual DIA EuroMeeting
  – OneMedForum

Financial Highlights:

Driven by the increase in new contract sales in the fourth quarter of 2011, revenue for the first quarter of 2012 increased 12% to $2.1 million compared to $1.9 million in the first quarter of 2011. The gross profit margin remained stable at 81% for the three months ended March 31, 2012 and 2011. The Company’s loss from operations for the three months ended March 31, 2012 was $(515,000) compared to $(198,000) for the corresponding period in the prior year. The operating losses for both years reflect the Company’s strategic investments in Sales, Marketing and Software Development to position the business for future growth, the accrual of management incentive plan awards, as well as costs incurred to protect the Company’s intellectual property for its customers and partners.

DATATRAK’s backlog at March 31, 2012 was $14.0 million compared to a backlog of $11.6 million at December 31, 2011. Backlog consists of future value from authorization letters to commence services, statements of work, technology and services agreements, change orders and other customer contracts, billed and unbilled. Backlog at March 31, 2012 increased over December 31, 2011 due to the increase in new contract sales. New contract sales for 2012 outpaced 2011 new contract sales by 170%.

“DATATRAK’s strategic growth investments over the last six months are starting to yield tangible results,” stated Mr. Laurence P. Birch, DATATRAK’s Chairman of the Board and CEO. “The DATATRAK ONE™ unified suite is a highly flexible and seamless clinical trials platform that provides our customers the most efficient pathway to market. With better focused and funded sales and marketing efforts, we are achieving traction in exposing a larger audience to the benefits of using a truly unified offering– one database, one login – resulting in lower total cost of ownership to our clients. C-level executives see the benefits of this cloud-based solution, resulting in increasing numbers of multi-year, multi-trial enterprise agreements.” Mr. Birch continued, “Although we are aware that we have much work to do going forward, we are pleased with the progress achieved to this point and look to the future with great anticipation.”

In news related to DATATRAK’s Board of Directors, Mr. Birch commented, “We are pleased to announce that on May 8, 2012, DATATRAK’s Board of Directors appointed James M. Karis as a Director to its Board. Mr. Karis is the CEO of CollabRx, Inc. which uses information technology to inform personalized cancer treatment planning by combining the world’s knowledge on cutting-edge therapies with specific insights from the nation’s top cancer experts.”

About DATATRAK International, Inc.

DATATRAK International is a worldwide technology and services company delivering eClinical solutions and related services for the clinical trials industry. DATATRAK built its multi-component, comprehensive solution on a single, unified platform and expanded this concept to include services delivery via DATATRAK’s Clinical and Consulting Services™ group. The Company delivers a complete portfolio of software products designed to accelerate the reporting of clinical research data from sites to sponsors and ultimately regulatory authorities, faster and more efficiently than loosely integrated technologies. The DATATRAK ONE™ software solution, deployed worldwide through an ASP or Enterprise Transfer offering, supports Phase I – Phase IV drug and device studies in multiple languages throughout the world. DATATRAK has offices located in Cleveland, Ohio; Bryan, Texas; and Cary (RTP), North Carolina. For more information, visit www.datatrak.net.

All contracts are subject to possible delays or cancellation or can change in scope in a positive or negative direction. Therefore, current backlog is not necessarily indicative of the Company’s future quarterly or annual revenue. Historically, backlog has been a poor predictor of the Company’s short-term revenue.

Except for the historical information contained in this press release, the statements made in this release are forward-looking statements. These forward-looking statements are made based on management’s expectations, assumptions, estimates and current beliefs concerning the operations, future results and prospects of the Company and are subject to uncertainties and factors which are difficult to predict and, in many instances, are beyond the control of the Company, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. For a list of certain of the factors that may cause actual results to differ materially from those contemplated in these forward looking statements, please see the Company’s annual report filed with the OTC Markets on March 16, 2012 announcing its results for the full-year period ending December 31, 2011. The Company undertakes no obligation to update publicly or revise any forward-looking statement whether as a result of new information, future events or otherwise.

Contact:

Lisa Pahl, Director Marketing, DATATRAK International, Inc., +1-979-393-9025

Ahead of the Curve: Re-engineering and Integration of Clinical Trial processes for Efficiency and Cost-reduction

Over the past 25 years I have been involved in implementing technology (EDC, CTMS, etc) in Clinical Trials and in revising processes for efficiency and cost-reduction. In one instance I was able to save the Sponsor $750,000 on one large trial by using technology more effectively and re-engineering the process.

The technology has greatly advanced over the years but the process for re-engineering is still effective. I have been involved in clinical trial process re-engineering for over 25 years so you can imagine the different changes in technology that I have seen and implemented. This blog will discuss the implementation of one type of technology… EDC.

In the past, re-engineering efforts involved processes within one department, such as Clinical Operations or Data Management. One of the recent changes in process re-engineering is the integration of clinical trial processes ACROSS departments for further efficiency and cost-reduction. With the implementation of EDC, a natural integration and process revision effort would be to review the data flow from collection to database lock as EDC provides many improvements in this area.

One of the most important steps is to ensure you have management support for these re-engineering efforts. Without management support, implementation of the changes will be challenging as many continue to support the “old ways” or are adverse to change. Second, you need to have people on the team that are open to change and think “out of the box” so they can “imagine” a better way of doing the work by concentrating on best practices and the advantages that the new technology provides rather than protecting the old ways or old turf.

To re-engineer these processes you first need to review all the current processes in all the departments that affect data flow from collection to database lock. For example, data collection at the site, eCRF design, monitoring, query resolution, etc. You will also need to know how the EDC system works as there are differences in functionality, databases, user interface, metrics, and how you can use the system for your benefit.

Once you have an understanding of this information, you can review each process to decide how use of the technology would improve or change the process perhaps eliminating steps or changing work or data flow. You should also review the process to update it according to best practices and most efficient work flow because redundant or ineffective processes tend to creep into the process over the years as different staff is involved in the process. After you do each department process, you would then look to integrate the departments’ processes concentrating on the best route for the data flow process.

Once the processes are defined, a few weeks of trying out the new processes and then, reviewing what works and what doesn’t will fine tune your new processes. Don’t forget to revise your SOPs to match the new processes and train all staff on the new processes. Reinforcement of the new processes might be needed along the way… but you are on your way now to being more efficient and cost-effective.

Metrics are great tools for assessing and evaluating efficiency and effectiveness. They are especially useful when discussing clinical data management and electronic data capture (EDC). Accessing and choosing metrics that have meaning and can be used to assess and evaluate a particular process sometimes poses a challenge. Unfortunately, there are no metrics that can be universally applied as each company has a specific workflow and working environment. However, there are some metrics that are often used across the industry. Like the use of acronmys commonly used in the pharmaceutical, biotechnology and medical device industries there is the possibiilty that they mean different things to different people. For example CRF or case report can be used to mean an entire casebook or it can be used to denote a specific form, page or module. Metrics too benefit from definition before they are used so everyone has the same understanding of their meaning and therefore can apply them in the same manner to assess and evaluate specific processes on equal footing.

For this short blog I would like to discuss two key metrics commonly used in our industry when discussing EDC: time to deployment and time to database lock. In both cases there are several aspects that need to be noted, discussed, and considered when using both of these metrics.

Time to Deployment
How effective an EDC vendor is in building an EDC application can be determined by measuring the time it takes from the initiation of a study to the deployment of the application in a production environment. In other words from the start of work to the time I, as the sponsor/customer, can use the application to collect clinical data. If you read other blogs or articles there have been several metrics noted from hours to 10-12 weeks as the time it take to deploy an EDC application. It is obvious that many of the claims come with certain caveats, for example I can build an eCRF in a matter of hours but does that mean that it is complete and has been tested and is ready for production – more than likely not. Conversely, I have witnessed instances where the time to deployment has taken 20-30 weeks. In many of these instances the sponsor has taken a significant amount of that time to conduct user acceptance testing or has opted to make changes to the protocol prior to study initiation (one reason why it is always a good thing to begin the EDC build process with a final protocol).

Therefore in order to make the best use of the time to deployment you need to make sure everyone involved knows the definition of the term, has an understanding of the process or workflow, and everyone has the same expectation of the meaning of deployment. With this common understanding then you can effectively assess and evaluate the process of building, testing and deploying and EDC application.

Time to Database Lock
A second metric commonly used in the industry to assess and evaluate the effectiveness of EDC is the time from the last patient last vist to database lock. Unlike the time to deployment, the measurement of the time from last patient last visit is a cornerstone metric in the industry. The workflows of paper and EDC are very different and understanding the EDC workflow that is being followed is critical in assessing the usefulness of this metric especially since the original parameters are the metric is based on a paper-based data collection process. An example of adjusting the metric to the workflow would be needed if your workflow (using EDC) requires source data verification. A more useful metric to measure is the effectiveness of the EDC process from the time of the last patient last monitoring visit when source data verification was completed to the freeze/lock of the database.

With these two examples there is a need to make sure that before the metrics are used there is a clear understanding of what will be measured, how it will be assessed and, most importantly, how will the assessment will translate into an action plan to continually improve and/or optimize the process.

I attended the DIA Euromeeting in Copenhagen on 26-28 March. DATATRAK was represented by myself, Senior Sales Director Scott DeMell, VP of Business Development and Strategy Bill Coates, CEO of DATATRAK Laurence Birch and CFO Jennifer Fox. Scott and I flew in from Geneva, whereas the rest of the DATATRAK team came straight from the US. The meeting was in the famous Copenhagen Bella Center, a spacious conference centre just across the river from the city centre. Copenhagen greeted us with a chilly misty Saturday, but the weather warmed up and it was sunny and warm for the rest of our stay.

The DIA Euro meeting is a combination of a supplier exhibition and series of lectures and talks. It is well attended and is the usual meeting place for many regulatory and clinical professionals in Europe. We had a number of pre-arranged meetings at our booth, caught up with some old friends and existing clients and spoke with a number of companies who could be using our technology in the future. DATATRAK’s senior executives also had an opportunity to meet with the heads of the companies we are working with face to face, creating trust and laying a foundation for future successful work.

My biggest observation from the meeting is that the landscape of the companies exhibiting at DIA Euromeeting is changing. While full service clinical CROs used to be the primary exhibitors, there were fewer of them at the conference. Whereas there seemed to be a higher number of eClinical companies exhibiting, covering all aspects of clinical development and marketing.

During the two weeks spent at BioEurope and at the DIA Euromeeting we had the opportunity to see clients and vendors in all segments of the pharmaceutical development industry, from drug discovery to registration and beyond. We have had a very good response from very different types of companies. While the pharmaceutical market may not be booming, it looks stable, set for growth and open for a good product at the right time.

With BioEurope Spring and DIA Euromeeting behind me, the hard work now begins as dozens of contacts made during the conference will be followed up in the coming weeks!

Webinar Questions and Answer Section:

1. I understand the value of offsite review but don’t monitors still need to source verify?

LE: Yes, the monitors still need to source verify but the percentage of SDV might not be 100% for every study. In most cases off-site review will allow some monitoring activities to be completed, but in some cases, on-site visits will still be done to some degree to view site performance and source verify.

2. What percentage of workload is spent by the monitor on SDV?

LE: The percentage depends on many study variables (e.i., therapeutic area, protocol, primary variables, risk factors, etc) so it varies widely.

3. Isn’t it part of the monitor’s job to confirm the accuracy of data provided to the site?

LE: Yes, that is part of the monitor’s job.

4. Can you explain the relationship between EDC and central lab data – how has/will this changed?

BG: EDC applications can handle lab data in several ways, however, for illustrative purposes there are two primary ways: first one can import the lab data and incorporate those data as part of the EDC application and thus part of the database, or second keep the lab data separated in a SAS dataset and then combine the data at the back-end when preparing for the study analysis.

5. Even some if the work of the monitors could be done off site, isn’t it still the crucial part of monitoring activities comparing CRF data with source documentation which has to be done on site?

LE: Many of the activities can be done through EDC and off-site. Other crucial parts of monitoring are assessing GCP and protocol compliance and monitoring site performance and some of that can be done remotely.

6. As you know with EDC, the info is only as good as what has been entered/ addressed by the site. What have you found works in changing the sites perspective to this new paradigm? i.e. how do you get them to have more continual interaction with EDC, rather than entering data and answering queries in preparation for on-site monitoring visits.

BG: When working with sites many of them are open to moving toward an electronic data capture (EDC) methodology for collecting study data. I have found that a combination of instructor-lead training with study coordinators followed by the availability of online training have been the best combination in teaching site personnel to work in an EDC environment. I have also found that essentially all sites that have used an EDC application successfully have requested that future studies also be in EDC as they too have gained benefits in organizing site data, seen increased compliance, and have found the overall process to be easier over time.

LE: Many sites prefer EDC now because they can answer system generated queries immediately, which saves them time. Also, they can answer queries when they have time and not only in frantic preparation the night before a monitoring visit.

7. What are your thoughts on embedding ePRO solutions within the EDC platform?

BG: There are some pros and cons for embedding ePRO solutions within an EDC platform. Some of the pros include the availability of all study-related data being on the same platform provides the sponsor with a single source for their data. There is a caveat here however, in some cases the ePRO solution may be integrated with the EDC application and essentially tied to it but where the data resides are still in separate platforms. The message here is to make sure you thoroughly understand what, where and how data will be tied together with your EDC application.

The con side of things is logistics – if the ePRO is embedded and a part of the EDC application then there are some challenges in user administration and customer support that you need to make sure are known and addressed prior to the initiation of the study. By this I mean the customers will not only be the sites but each of the patients. So you must know who will be supporting the ePRO portion of the applications – if it is the EDC vendor then do they have experience with the device(s) to enter data and do they have the support infrastructure to support your patient population.

8. In the case study, was the 300k wasted?

BG: In the example case studies the entire $300K was not wasted as they were edit specifications already documented that were utilized downstream as were the other essential documents that were already created. However, the short answer is yes.

9. How can you remotely monitor if source documents are still on site?

LE; There are other activities to monitoring than source verification. Review for missing data, inaccurate data, trends across pts or sites in data completion issues, etc. can be done.

10. Who exactly determines by study what percentage of SDV must be done?

LE: It depends. Usually it’s the sponsor or CRO when they write their monitoring plans.

11. Can you talk about EDC solutions and the study validation? How does that work? Who, the sponsor or EDC provider, does the validation?

BG: EDC solutions and applications developed for studies are validated prior to being moved to a production environment. The core code for any EDC solution has validation documentation on file for inspection to demonstrate 21 CFR Part 11 compliance. The EDC vendor is responsible for ensuring Part 11 compliance is maintained, however, it is ultimately the end-user, the sponsor or customer, who is responsible for the study. They must demonstrate that they have done their due diligence and conducted an audit to ensure the documentation exists and their vendor is in compliance. Long story short the sponsor must make sure all validation work has been done.

LE: According to part 11, the Sponsor must also validate the use of the EDC system in their environment. See Part 11 for more information.

12. For some small companies, money is always an issue, besides CDM what can be done? Are monitors monitoring more studies or just utilizing time on a study in a better way?

LE: Monitoring time is utilized in a better way and is more efficient and productive. In most cases, money can be saved if the monitoring process is re-engineered.

13. Could you precise which control can be preformed during off site monitoring and how much data management can help monitors during this off site monitoring?

BG: From the CDM perspective query management is perhaps one of the most important factors where integration of the groups, and knowing what everyone’s role on the team is, is essential. Monitors have great insight to what is happening at each of the sites for which they have responsibility to monitor. CDM on the other hand has a better picture of what is happening across sites and thus both groups can tailor their queries depending upon focus. By having a tightly integrated plan and communication site monitors can gain a full study perspective prior to a site visit and make the visit highly productive and in some instances reduce the need for some queries or reduce the need for some follow-up calls or visits.

14. Our company has recently started implementing EDC, how can we integrate CliOps and DM group

BG: The best ways you can integrate the groups is make them part of the implementation process. It is critical that both groups work together and define processes and procedures that define a workflow that will work in your specific culture and environment. As mentioned in the webinar you can use the EDC implement as a means make sure members of these respective teams are named to the implementation team so a cohesive and coordinated workflow is designed to take full advantage of the many benefits that can be gained through the use of the technology.

LE: You need to determine current workflow and re-engineer it to reflect a new data flow and workflow that is possible with EDC. Each group needs to define activities that need to be done and then discuss how those activities will be done and by whom. This is a complicated question that requires much more discussion than can be done here.

15. Does reducing monitoring work have some financial gains in ways of less numbers of monitors?

LE: If your risk-based monitoring plan includes less on-site monitoring, it may save cost.

16. How can you help me in understanding EDC better?

BG: This is an open-end question and I honestly do not know where to begin, however if there is a specific question I would be happy to respond individually – I can be reached via e-mail at bill.gluck@datatrak.net

17. FDA Guidance risk-based monitoring Aug, 2011 seems to be the DRAFT version and “not for implementation” Do you have the final guidance?

LE: As far as I know the final guidance has not been released. However, FDA seems to indicate that they support what they wrote.

18. Why can’t monitors just have the site fax the source documentation to them to source verify instead of having to come to the sites, especially when it is just to source verify one change related to a query which happens a lot when getting ready for the database lock?

LE: Patient confidentiality is an issue when source is faxed. Also, if they only send you one document, how do you know there isn’t other or conflicting information in the chart.

19. Can you speak to the value of the use and standardization of EDC in the creation/submission preparation of SDTM data sets?

BG: I am a huge proponent of standardization and the use of standards. CDISC has evolved quickly and has provided the industry with some great guidance on how to move us all in the same direction – that core group and all of the industry participants need to be congratulated.

By knowing how you want your data exported (form and structure) it is easier to wok backwards in setting up your EDC application so that you can make use of the various CDISC standard and optimized the environment so there is a more seamless transition to the generation of the SDTM datasets. There will be some programming that will need to be done, however, there are configuration and naming conventions defined by CDISC that can make this transition easier.

20. Is there an impression of sponsors that we are moving more rapidly toward better use of EDC for the purpose of data integrations? Are you under the impression we still have a way to go?

BG: There has, in my opinion, been a tremendous amount of improvement and enhancements in the tools EDC and in a more general sense tools to address the eClinical landscape over the 5-10 years. Vendors have listened to their customers and have made, and continue to make, these enhancements. The one area I think we need to progress into is trying to move away from data integrations of separate systems and move to a more unified environment. The FDA outlined their thoughts in the draft guidance that is published on eSource and hopefully will soon provide the revised guidance document incorporating the comments from the industry (I refer to the industry in the broadest sense to include pharmaceutical, biotechnology and medical devices). I also think there are additional ways to leverage technology to further enhance the handling and management of data – no I do not think we have gotten to where we need to be and hopefully we will continue to make improvements in how we use all of the tools available to us not and those tools that will be discovered/developed in the future.

21. Is it your experience that there is a true savings of resource and resources cost in the use of EDC? Where monitoring is considered or has the use only changed the focus of the monitors and the number and cost of the resources not truly charged?

BG: I can say that I feel there are true savings achieved through the effective use of EDC. The availability of cleaner data sooner and essentially upon demand has, in my experience especially in the past 20 years of working in a sponsor environment, has lead to better and more informed decision-making. Being in the position to make a ‘Go/No Go’ decision sooner translates into considerable savings of resources and cost. The availability of safety data likewise translates into savings especially when we look at protecting patients and ensuring patient safety.

In terms of resources and costs I have found through the use of EDC I have been able to use a model where I could demonstrate how to do more with less – more studies less people, more studies lower CDM costs. This model was one where we evaluated and selected an EDC vendor, worked with our vendor to transfer the knowledge and the ability to do our study builds internally but host our data externally (typically with the EDC vendor in an ASP or trusted third-party model). This environment provided our group with the ability to control our resources, better prioritize studies (reflecting the changing internal priorities of our company), and be in a better position to leverage the resources of our internal CDM group.

LE: From our experience over the past 7 years, if monitoring is re-engineered for EDC and risk based monitoring plans are used, cost can be saved.

CLEVELAND, [April 2] /PRNewswire/ — DATATRAK International, Inc. (OTCQX: DATA), a technology and services company focused on global eClinical solutions for the clinical trials industry, today announced RPS (ReSearch Pharmaceutical Services, Inc.) selected DATATRAK as a preferred vendor and joined DATATRAK’s CRO Connect Partner™ program. RPS is a global Contract Research Organization (CRO) with more than 3,000 employees operating in 45 countries.

“RPS is excited to announce that it has selected DATATRAK as one of its preferred vendors in order to maximize the benefit and minimize the cost in using DATATRAK’s unified software suite, DATATRAK ONE™,” stated Daniel Perlman, RPS CEO and Chairman. “We strongly believe that the industry leading solutions of RPS, combined with DATATRAK’s robust Technology solution will bring our customers excellent quality, data integrity and responsiveness at a highly competitive price. After several years of experience working together, this seemed to be the next logical step in enhancing our combined offering.”

“RPS is a great new addition to our CRO Connect Partner™ program, and we are excited to be providing them the most powerful SaaS clinical research platform in the world,” stated Laurence P. Birch, DATATRAK’s Chairman of the Board and CEO. “This partnership was a natural progression as a result of our work with RPS on client studies and their participation in our Product Advisory Council. We look forward to continued growth for both companies.”

About RPS

RPS provides comprehensive global Phase I-IV clinical development solutions to the Pharmaceutical, Biotechnology, Medical Device and Diagnostic industries. By combining our highly experienced clinical research operations infrastructure with the industry’s largest resourcing engines, RPS is uniquely positioned to offer our Customers a broad spectrum of outsourcing solutions. These solutions range from globally embedded functional and cross-functional programs to enhanced global full-service solutions, and are powered by highly experienced project teams providing innovative, seamless, cost-effective and high quality services. With more than 4,000 employees, RPS operates in 64 countries across the globe. See www.rpsweb.com for more information.

About DATATRAK

DATATRAK International is a worldwide technology and services company delivering eClinical solutions and related services for the clinical trials industry. DATATRAK built its multi-component, comprehensive solution on a single, unified platform and expanded this concept to include services delivery via DATATRAK’s Clinical and Consulting Services™ group. The Company delivers a complete portfolio of software products designed to accelerate the reporting of clinical research data from sites to sponsors and ultimately regulatory authorities, faster and more efficiently than loosely integrated technologies. The DATATRAK ONE™ software solution, deployed worldwide through an ASP or Enterprise Transfer offering, supports Phase I – Phase IV drug and devices studies in multiple languages throughout the world. DATATRAK has offices located in Cleveland, Ohio; Bryan, Texas; and Cary (RTP), North Carolina. For more information, visit www.datatrak.net.

Except for the historical information contained in this press release, the statements made in this release are forward-looking statements. These forward-looking statements are made based on management’s expectations, assumptions, estimates and current beliefs concerning the operations, future results and prospects of the Company and are subject to uncertainties and factors which are difficult to predict and, in many instances, are beyond the control of the Company, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. For a list of certain of the factors that may cause actual results to differ materially from those contemplated in these forward looking statements, please see the Company’s report filed with the OTCQX Market on March 16, 2012 announcing its fourth quarter and full year results for 2011. The Company undertakes no obligation to update publicly or revise any forward-looking statement whether as a result of new information, future events or otherwise.

Contact:

Lisa Pahl, Director Marketing, DATATRAK International, Inc., +1-979-393-9025

The Bio-Europe conference series is one of the best networking opportunities in Europe. Over 4 days healthcare industry professionals have an opportunity to meet and discuss ways of doing business together. At the core of the meeting is its partnering networking system powered by EBD Group, which allows thousands of participants to quickly locate each other and arrange 30 minute meetings, which are then automatically scheduled. Along with the meetings there are also several streams of presentations and an exhibition area.

The main intent of the meeting is to allow biotech companies to meet with potential licensees (pharmaceutical companies and venture capitalists). But since smaller biotech companies are often represented by CEOs and other senior decision makers rather than dedicated licensing professionals, this conference is a great opportunity for vendors to meet decision makers from biotech companies. And it’s a great opportunity for DATATRAK to meet both vendors and biotechs.

Amsterdam, where this years’ BioEurope Spring conference was, is only a short train ride away from Aachen, Germany, where I am based. The conference started with an evening networking event at a club in Amsterdam city centre, followed by 3 days of networking meetings, presentations and exhibition in the Amsterdam RAI conference centre. Along with networking meetings arranged in advance, there were plenty of opportunities to meet during breaks and networking dinners organized in the evening.

The discussions I have had with numerous people during the event confirmed my view that eClinical market is in the state of flux. Gone are the days when companies expected to stick with a platform forever. Users recognize that the technology world changes rapidly, and in order to keep up with the change they need to know what emerging technologies exists. And increased efficiency of modern eClinical solutions means that companies which previously thought clinical trial technology was out of their reach and they have to make do with paper, are warming up to the idea of moving from clumsy pieces of paper to a sleek computer screen, or even a flashy tablet.

The conference was a great opportunity for me to catch up with some old business contacts and create new ones. I left with my business card holder full, and there are plenty of exciting opportunities to work on, both with biotech companies and with service providers. Busy days ahead as we are moving towards the DIA EuroMeeting in Copenhagen next week!

DATATRAK will be showcasing its unified cloud-based clinical research platform, DATATRAK ONE™. The end-to-end clinical enterprise solution empowers users and service providers with the components necessary for efficiently designing, delivering and managing clinical trials. Visit Booth 235 in the Bella Center to see how DATATRAK’s simple, easy-to-use tool set, DATATRAK ONE™, safely accelerates drug and device programs from Concept to Cure™.

About DIA EuroMeeting

The EuroMeeting attracts more than 3,000 professionals from over 50 countries. It brings together professionals from the biopharmaceutical industry, contract service organisations, clinical research, regulatory agencies, health ministries, patients’ organisations and universities. This convergence affords attendees the opportunity to network with professional colleagues from around the world. For more information, see www.diahome.org.

About DATATRAK

DATATRAK International is a worldwide technology and services company delivering eClinical solutions and related services for the clinical trials industry. DATATRAK built its multi-component, comprehensive solution on a single, unified platform and expanded this concept to include services delivery via DATATRAK’s Clinical and Consulting Services™ group. The Company delivers a complete portfolio of software products designed to accelerate the reporting of clinical research data from sites to sponsors and ultimately regulatory authorities, faster and more efficiently than loosely integrated technologies. The DATATRAK ONE™ software solution, deployed worldwide through an ASP or Enterprise Transfer offering, supports Phase I – Phase IV drug and devices studies in multiple languages throughout the world. DATATRAK has offices located in Cleveland, Ohio; Bryan, Texas; and Cary (RTP), North Carolina. For more information, visit www.datatrak.net.

Except for the historical information contained in this press release, the statements made in this release are forward-looking statements. These forward-looking statements are made based on management’s expectations, assumptions, estimates and current beliefs concerning the operations, future results and prospects of the Company and are subject to uncertainties and factors which are difficult to predict and, in many instances, are beyond the control of the Company, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. For a list of certain of the factors that may cause actual results to differ materially from those contemplated in these forward looking statements, please see the Company’s report filed with the OTCQX Market on March 16, 2012 announcing its fourth quarter and full year results for 2011. The Company undertakes no obligation to update publicly or revise any forward-looking statement whether as a result of new information, future events or otherwise.

Contact:

Lisa Pahl, Director Marketing, DATATRAK International, Inc., +1-979-393-9025