In November 2009, the FDA held a public hearing about their approach to regulating the promotion of medical products on the Internet and social media outlets.

In August 2011, Facebook changed its policy and removed the option to shut off the comment sections on fan pages, claiming that it would encourage more open dialogue between consumers and companies. That change resulted in many pharma companies, like Amgen, shutting down their fan pages, especially those solely dedicated to specific drugs.

Finally, on December 30, 2011, in response to the 2009 public hearing, the FDA released their DRAFT Guidance Responding to Unsolicited Requests for Off-Label Information about Prescription Drugs and Medical Devices, which was geared toward addressing off-label use and social media. The 15-page document addresses how companies should advise customers looking for additional prescription drug information but lacked any direction regarding use of social media in pharmaceuticals, which still leaves many questions unanswered. Organizations were expecting a full outline, with specific rules and regulations for regulations, concerning the utilization of social media outlets, however, the guidance still leaves a lot to interpretation. The FDA did, mention Twitter and YouTube, which can be taken as an indicator that they are beginning to acknowledge digital outlets.

Using these digital outlets, “firms may choose to respond to unsolicited requests for information about off-label uses of their approved or cleared products in a manner other than that recommended in this draft guidance. Such activity would not constitute a per se violation of the law, but could potentially be introduced as evidence of a new intended use.” – FDA DRAFT Guidance

Meaning – if a potential customer posts a question on Facebook or Twitter inquiring if it is safe for a 35-year old woman to take Tamiflu – a Tamiflu representative, from maker Gilead, can answer the question in that channel. Yet, if a person were to ask if Tamiflu could be used to also treat food allergies, the representative should advise the person to visit the Tamiflu website for more information.

FDA spokeswoman, Karen Mahoney, tells Adage, “[It is] the first of multiple planned guidances that respond to testimony and comments from the Part 15 public hearing that the FDA held in November 2009.”

Because of the possible liability issues, social media sites cannot be as effectively leveraged for the marketing purposes as they maybe by retail business, such as Gap and Starbucks. Hopefully, in the near future, the FDA will issue guidance that provides more insight for Internet Marketers in the pharmaceutical industry.

1. DATATRAK Reveals Quarterly Results, Highest Since 2008

DATATRAK continues its recovery with its highest quarterly sales since 2008. The company attributes its growth in sales to a number of factors including greater stabilization where a previous administration failed to deliver on many fronts. OneMedRadio’s interview with CEO Larry Birch describes the continued progress for this provider of advanced software systems for the clinical trials industry. With reported revenue of over $2 million in the last quarter, Birch is confident his team is creating a powerful company with a “better technology than its competitors.”

Continue reading the full blog post

2. Electronic Source Documentation in Clinical Trials

DATATRAK was excited to see the FDA issued their eSource draft guidance in December 2010 with the intention to help promote the capture of source data in electronic form. The FDA’s intentions are good and they are bulleted on page 4 of the draft guidance:
· eliminate unnecessary duplication of data,
· reduce the opportunity for transcription errors,
· promote the real-time entry of electronic source data during subject visits, and
· ensure the accuracy and completeness of data (e.g., through the use of electronic prompts for missing or inconsistent data).

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3. Paper-based Verses Web-based or EDC Applications – An Overview

Given advances in technology and improvements in EDC applications the pharmaceutical, biotechnology, and medical device industries have not embraced EDC as the standard method of collecting clinical data. The debate continues about which is better – paper or EDC.

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4. A Risk-based Approach to Vendor Management

In June this year, I attended DIA for the first time in Chicago, Illinois. I was asked to speak for Track 09 (Regulatory Affairs and Sciences, Quality, and GXP Compliance). The topic was on vendor management and how I believe a risk-based approach should be applied. It was unusual to have a technology vendor speaking and one of the audience members applauded our group for including that perspective. I perform vendor assessments and audits, but a larger portion of my job is sitting on the other side of the table as the auditee of pharmaceutical, CRO and medical device customers. The topics I spoke on stemmed from my knowledge of both performing and facilitating vendor audits.

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5. Why Electronic Data Capture? Benefits for Statistics

Electronic data capture (EDC) is not a new technology in terms of age as it has been practiced, although not widely, in the industry for more than 25 years. Early EDC applications did not have the extensive functionality to evaluate the quality of the data as the current systems have. As EDC applications matured, it became evident that process, role, and procedural changes would be needed in order to realize the full benefits of the technology. While the focus of many of these is within the monitoring, collection and management of data, biostatistical benefits are also recognized.

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CLEVELAND, [January 25] /PRNewswire/ — DATATRAK International, Inc. (OTCQX: DATA), a technology and services company focused on global eClinical solutions for the clinical trials industry, today announced the newest member of its Connect Partner Program, Excel Life Sciences (ELS). Excel Life Sciences is a leading US-based, India-operating provider of comprehensive clinical trial and site management services.

“Excel Life Sciences is committed to providing our biopharmaceutical company clients with extraordinary clinical trial management performance and the highest data quality and integrity for their global trials in India,” remarked Dan McDonald, Excel Life Sciences SVP of Business Strategy. “In joining the Connect Partner Program, we renew this commitment by offering our clients access to DATATRAK’s leading eClinical Solutions and Consulting Services. Excel Life Sciences is proud to announce this new partnership and is excited about the future of working with DATATRAK to meet our clients’ evolving needs.”

“We are thrilled about Excel Life Sciences joining the DATATRAK Connect Partner Program,” stated Dr. Bill Gluck, VP DATATRAK Clinical and Consulting Services™. “The partnership will assist both companies in reaching their goal of providing the most innovative clinical trial solutions throughout the industry. The level of experience, passion and commitment in producing the highest quality solutions makes this an invaluable partnership.”

About Excel Life Sciences

Headquartered in Chicago, IL with offices in Boston, Raleigh-Durham, New Delhi (India HQ) and Kolkata and 17 other locations across India, ELS is one of the most experienced and fastest growing trial management and site support organizations in India, offering customized clinical trial solutions including: regulatory consulting, preparations, submissions and query resolution; site identification and selection; patient recruitment and retention; training of all clinical research stakeholders; technology transfer; product licensing and more.
ELS has one of the most experienced and respected clinical operations teams in India with over 280 years of collective experience in conducting more than 350 global and domestic trials at hundreds of sites and with thousands of patients. ELS has also trained over 1,500 clinical research personnel in India. For more information visit:www.excellifesciences.com

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 http://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 announcing its results for the three-month period ending September 30, 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

Last week I headed out to San Francisco for the 5th annual OneMedForum. Over the past four years, the forum has not only grown in size and reach, but also in structure, including company presentations, panels and workshops. The forum aims to provide the latest medical technology trends, best practices, strategic insights, innovated ideas and much more to high level investors and healthcare industry leaders.

At conferences such as the annual OneMedForum, the relationships that are built help to cultivate synergistic partnerships that are critical in further extending the reach of healthcare market research. It is such a thrilling experience to be surrounded by passionate industry leaders that invest in and analyze the healthcare market.

The OneMedForum was such a great way to get 2012 off to great start. I cannot wait to see what this year brings in the healthcare industry.

CLEVELAND, [January 18th] /PRNewswire/ — DATATRAK International, Inc. (OTCQX: DATA), a technology and services company focused on global eClinical solutions for the clinical trials industry, today announced a completely new product design for their randomization and clinical supplies management product, uIRT. As a unified product within the DATATRAK ONE™ suite, the new release of uIRT positions DATATRAK as the most advanced unified Randomization and Clinical Supplies Management system in the marketplace today.

“DATATRAK has been supporting clinical trial randomizations and drug inventory management since 2005,” stated DATATRAK CTO Chris Wilke. “With this new release, we’ve made huge strides in the technologies available to the marketplace today. We listened to our clients and have now turned over the control of managing trial randomizations to Sponsors and CROs.”

Clients can configure and maintain randomization and clinical supply allocation throughout the life of the clinical trial without DATATRAK assistance. With this new release, users will experience the following:

• Increased performance when generating randomization schedules, importing strata and populating or importing inventory schedules.
• Robust Manager functionality allowing users to view, filter, update and export information on drug containers, drug assignments, shipments and randomization schedules.
• Standard reports and system-wide exports available 24/7 in real-time to effectively manage time sensitive randomization and inventory needs.

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 announcing its results for the three-month period ending September 30, 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

uCTMS

Managing All Aspects of Your Clinical Trial

DATATRAK expanded its CTMS-like functionality in the uEDC into a comprehensive Clinical Trial Management System, uCTMS. Users can collect data, manage documents and report on trial activities from planning and monitoring to expense tracking and study budgets. Dashboards and standard reports summarize study metrics in both table and graphic formats and include reporting across multiple studies. uCTMS provides the tools necessary for your teams to manage both their study and their data.

uIRT Release

Handing Over Control of the Randomization and Inventory Process

The new release of uIRT positions DATATRAK as one of the most advanced Randomization and Clinical Supplies Management systems in the marketplace today – and it can be configured and maintained by you! Users will experience increased performance when generating randomization schedules, importing strata and populating or importing inventory schedules. The uEDC Manager concept has been extended to uIRT for users to view, filter, update and export information on drug containers, drug assignments, shipments and randomization schedules. Standard reports along with system-wide exports are available 24/7 in real-time to effectively manage your time sensitive randomization and inventory needs.

uEDC Release

Creating Efficiencies in the Data Cleaning Process through Workflow

Query Workflow
Implement query reviews and approvals with the new Query Workflow functionality. Queries can be initiated by data management or monitoring team members and then reviewed by team leads before they are actually visible to the site. By configuring query workflow within the electronic data capture system, users automate their review and approval processes with all the benefits of unified EDC.
 
Inline Query Responses
Respond to queries directly on the eCRF and reduce clicks by utilizing standardized pick list responses. In addition, users no longer have to update a data response and then signal response to the query via clicking the Query is Addressed button; studies can be configured to update the query status based on data changes. These new query features reduce the amount of time coordinators spend in the system and free them up for patient care.

Email Notifications
Keep all study team members in the loop on important study milestones with automated email notifications. The online email notification interface, allows users to easily manage the recipients and metadata actions (SDV, Freezing, Locking and Signatures) requiring notifications. Notifications can be updated in real-time, 24/7.

Form Flow
Move your eCRFs through predefined flows for better task and data visibility. The configurable form flow allows users to create study specific workflows without any custom programming.

For more information please contact your sales representative or Lisa Pahl at lisa.pahl@datatrak.net

CLEVELAND, [January 9th] /PRNewswire/ — DATATRAK International, Inc. (OTCQX: DATA), a technology and services company focused on global eClinical solutions for the clinical trials industry, today announced the release of its new product, uCTMS. As a unified product within the DATATRAK ONE™ suite, this release positions DATATRAK’s uCTMS as the most comprehensive unified Clinical Trial Management System in the cloud.

“The new release of our CTMS product improves visibility for executive management and gives clinical operations teams more control of their pipeline, especially when leveraging collaborative partnerships,” stated Laurence P. Birch, DATATRAK’s Chairman and CEO. “It is exciting to have the uCTMS product as part of our DATATRAK ONE™ clinical research platform that assists customers with the strategy, planning and management of their entire product portfolio.”

uCTMS allows for the management of the large amount of data involved during a clinical trial – from the planning stages of the trial all the way to its completion. Specifically:

• Collect data and manage documents
• Report on trial activities from planning and monitoring to expense tracking and study budgets
• Utilize standard dashboards and reports to summarize study metrics in both table and graphic formats
• Report across multiple trials

uCTMS provides the tools necessary for study teams, sponsors or outsource partners to manage both their individual studies and their data in real time, while allowing trial administrators and executives to have a global role-based view of all studies.

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 announcing its results for the three-month period ending September 30, 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

About OneMedForum

OneMedForum San Francisco 2012 runs concurrently with the J.P. Morgan conference and provides efficient access to the companies that shape the future of the rapidly changing healthcare landscape. The forum is designed to create a communications platform for emerging companies to connect with strategic partners and investors.

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 announcing its results for the three-month period ending September 30, 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

We couldn’t just collect the items and put them in a box; the display had to be something special itself! By the end of the month, we were all ecstatic about how much people gave and how creative we had become!

By the end of the collection the company as a whole collected over 2,200 items weighing about 1,300 pounds.

In addition to collecting items for local food banks, the Bryan, Texas office has taken it one step further and reached out to grocery chain, HEB, who has generously decided to match the donations.

CDASH – Clinical Data Acquisition Standards Harmonization
LAB – Laboratory Data Model
ODM – Operational Data Model
SDTM – Study Data Tabulation Model

“As a leader in eClinical solutions, standards play a very important role in our acceleration of drug development timelines,” stated Laurence P. Birch, DATATRAK’s Chairman of the Board and CEO. “Our CDISC Registered Solutions Provider status officially recognizes our internal practices and strengthens our involvement in the global effort to improve efficiencies in clinical research.”

About CDISC

CDISC is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. For more information on CDISC, please see www.cdisc.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 quarterly

report filed with the OTCQX Market announcing its results for the three-month period ending September 30, 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