Plymouth Meeting, PA – September 27, 2011: In accordance with the new FDA regulation, set in April this year, CRF Health’s TrialMax® has become the first ePRO system to complete its Medical Device registration, a regulation that concerns medical device data systems (MDDS) that collect information from apparatus such as spirometers and glucometers.
TrialMax® is categorized as a Class 1 MDDS under regulation 21CFR 880.6310 (code OUG). And because it uses alarms to remind subjects when to take their study medication, it’s also classified as a ‘medication reminder’ under regulation 21CFR 890.5050 (code NXQ). This makes TrialMax® exempt from pre-market review but still subject to medical device 21CFR 820 quality standards, a practice to which CRF Health is fully compliant.
Rachael King, CEO explains, “CRF Health improves data collection by removing the barriers between intimate patient experiences and the technology designed to capture them. Our ability to collect data directly from medical devices, reinforces this philosophy, and our belief that the best way to get the cleanest, highest quality PRO data is by getting closer to the patients than anyone else.”
“We strive to make your ePRO experience a positive one,” added Greg Gogates, VP Quality Management and Regulatory Affairs.” Our timely response to the new FDA regulation is just another way in which we ensure your clinical study will run as smoothly as possible. Working with us means your clinical trials won’t be impeded by new industry requirements,” he said. “And, as always, our dedicated project managers will guide you through your study every step of the way, minimizing the risk of delays and maximizing the chance of delivering your study on time.”
Plymouth Meeting, Pa – August 30, 2011: CRF Health, a leading global provider of ePRO solutions for the Life Sciences Industry, today announced an open ePRO integration interface, which enables Sponsors and CROs to integrate their own eClinical systems with CRF Health’s acclaimed ePRO platform, TrialMax®, to provide data collected from patients in real time to all study stakeholders.
The TrialMax Synapse™ open interface integrates ePRO data collected with CRF Health’s TrialMax® platform to other eClinical systems in real time using the CDISC ODM standard. The current studies integrated to a leading EDC system are seeing a variety of benefits, including the enabling of sites to view all study data in one system, increasing the efficiency of drug accountability, facilitating data management, and allowing easier correlation of adverse events.
Rachael King, CEO of CRF Health, comments, “We have seen a significant increase in interest for integrating ePRO data to other eClinical systems, and are currently using integration in several studies. As the use of integration has exceeded all of our expectations, we decided to offer the possibility to all Sponsors and CROs that we are working with.”
The TrialMax Synapse™ open interface offers efficient tools for setting up and maintaining integration in individual clinical studies, according to their specific needs. Pekka Keskiivari, Chief Technology Officer, continues, “Real time integration of study data is the future of eClinical. By using good technology along with relying on standards, we can make the deployment very straightforward. In the future, integration will be an expected part of setting up a trial.”
Plymouth Meeting, PA – August 1, 2011: CRF Health, a leading global provider of ePRO solutions for the Life Sciences Industry, announced that the Company’s revenues for the six month period ending June 30, 2011 more than doubled from the same period in 2010, while earnings showed an even larger percentage increase over the prior period. CRF Health has now consistently generated earnings over the last ten consecutive quarters. CRF Health also added more than 15 new sponsor or CRO relationships while retaining 100% of its key account client base during that time.
“We’re excited to show continued strong financial performance with revenue more than doubling and profits up even more,” said Rachael King, Chief Executive Officer. “Our financial success allows us the freedom to continue focusing on customer service and expanding our technology offerings.”
Jeffrey S. Payne, Chief Financial Officer, commented, “Sponsors need to know not only that they can trust a partner with their data, but that their partner is financially stable and will be there in the future. Our continued strong financial results validate that Sponsors can trust CRF Health to be there in the future, while our growth in revenue evidences Sponsor’s recognition of the quality services we provide. CRF Health is proud to continue on its path of outstanding customer support as well as consistent profitability.”
Plymouth Meeting, PA – June 10, 2011: CRF Health, a leading global provider of ePRO solutions for the Life Sciences Industry today announced new medical device integrations to support both spirometers and glucometers used in Phase I-IV respiratory and diabetes clinical trials. CRF Health’s eDiary TrialMax® platform now integrates with Entra Health Systems’ Bluetooth-enabled MyGlucoHealth Wireless Meter and Vitalograph’s Asma-1 electronic Peak Flow Meter.
The wireless integration of our eDiaries with these medical devices results in more accurate data by removing the need for manual transcription of the data values. The date and time stamp of the reading and the device serial number are also transferred, providing evidence of the timeliness of the data and an attributable source. Once the eDiary receives the values from the glucometer or PEF meter, the values can automatically be sent to the ePRO database for review by the site personnel or study team. This allows very close to real-time monitoring of the subject’s status and permits timely intervention for safety or compliance concerns.
Benefits for clinical trial Sponsors include:
- Near real time access to all patient-generated data
- Defensible data that meets the FDA’s ALCOA standard
- Ease of use – no wires or cradles to connect
- High compliance to protocol (reminder alerts)
- No data transcription errors
CRF Health is featuring an ‘ePRO-Integration Station’ at booth 1100 in this year’s DIA Annual Meeting, June 19-23 in Chicago.
This demo station will include integration demonstrations for:
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ePRO and EDC
- Spirometer – eDiary – EDC (Respiratory Studies)
- eDiary and Glucometer (Diabetes Studies)
Rauha Tulkki-Wilke, Director Product Management, CRF Health, commented, “We are excited to provide our clients with the opportunity to collect all data directly from patients in their respiratory and diabetes studies. The integration is truly user-friendly with no burden on patients or site staff. For example, with in home spirometry testing, the subject simply needs to blow into the meter and the peak flow values are automatically transferred via the eDiary to investigative sites for review. It is the smoothest integration I’ve seen.”
Plymouth Meeting, PA – June 8, 2011: CRF Health received approval to use an electronic version of the St. George Respiratory Questionnaire on its tablet PC based TrialSlate™ devices from instrument developer Professor Paul Jones of St. George’s University of London. The TrialSlate™ version can be considered equivalent to the paper version of the questionnaire according to the “Recommendations on Evidence Needed to Support Measurement Equivalence between Electronic and Paper-based Patient-Reported Outcome (PRO) Measures: ISPOR ePRO Good Research Practices Task Force Report” which provides guidelines for industry in response to the FDA PRO Guidance.
A study demonstrating the general usability and absence of any major issues with respondents completing the SGRQ on the tablet device was conducted by United BioSource Corporation (UBC) on CRF Health’s behalf and the results were summarized in a report.
The electronic version of the SGRQ provides clinical trial managers more flexibility in designing trials along with the many other benefits of using ePRO, including improved compliance, higher quality data, and more efficient clinical trials.
Mary Briggs, VP Global Sales & Marketing, commented, “Gaining these types of approvals from instrument authors and partnering with valued PRO thought leaders to expand the use of technology in clinical trials are two examples of CRF Health’s strategy to offer the best services in the global ePRO marketplace.”
Plymouth Meeting, PA – June 7, 2011: CRF Health, a leading global provider of ePRO solutions for the Life Sciences Industry will present at the Massachusetts Biotech Council’s Biostatistics & Data Management Committee meeting on June 14, 2011 in Cambridge, MA. John Hutchin, Senior Director, Technical Support, will present on the topic, “ePRO: Options, Regulations, and Evolving Technology”.
ePRO (electronic Patient Reported Outcomes) is a growing methodology used in clinical trials to collect the self-reported health status of patients via an electronic data capture. This session will address the advances in ePRO technology, how the ePRO industry is evolving and how Sponsors will be able to benefit even more from ePRO in the future. With greater emphasis being placed on PRO data by regulators and clinicians, Sponsors must evaluate and implement the best technical offering to satisfy the protocol or program’s requirements.
The agenda will cover:
- Overview of the types of ePRO modalities and the benefits/limitations of each
- Review of the FDA PRO Guidance for Industry documents
- Challenges for ePRO Service Providers and Sponsors
- Validation, Equivalence, and Usability
- Future of ePRO
Mary Briggs, VP Global Sales & Marketing commented, “We are honored to be invited by the members of MassBio to present on the important topic of ePRO options and modalities.” Over the past year, John Hutchin has been an invited speaker at DIA, SCDM, and APS and we are glad to have him also support the Northeast Biotech sector.”
MassBio’s Website: http://www.massbio.org/
Plymouth Meeting, PA – May 10, 2011: CRF Health, a leading global provider of ePRO solutions for the Life Sciences Industry today announced the appointment of John Larson to the position of Chief Operating Officer. In this role, John will be responsible for global operations and lead the Client Services, Logistics and Helpdesk functions.
John joins CRF Health from Medtronic, Inc. Surgical Technologies where he served as Head of Global Services, overseeing the inception and development of Medtronic’s worldwide services business for surgical navigation and intra-operative imaging.
A twenty four year veteran of the Technology and Medical Device sectors, John has held leadership roles at several Global 500 companies. From product development through life cycle management; consultative selling; marketing to services and support, he brings a customer centric approach to managing operations and setting strategy.
John served as Head of Global Services for Medtronic Surgical Technologies and was responsible for developing clinical, professional and technical services, and supporting the corporation’s international expansion. This included a full integration of Medtronic’s intellectual properties in surgical navigation and imaging into a sustainable value proposition to the market place.
Prior to his work at Medtronic, John gained practical business perspective with Philips Medical Systems (Vice President and General Manager, Integrated Clinical Solutions), Agfa Healthcare (Vice President, Services and Support), StorageTek (Vice President, Global Services), Toshiba Computer Systems (Vice President, Technical Services and Support), AT&T and NCR.
Rachael King, CEO commented, “We are delighted to have John Larson join CRF Health as its COO. John has a proven track record of delivering excellence and his complimentary experience in the Medical Device area will help broaden CRF Health’s offering. John’s focus on “voice of the customer” integrates well with our continual improvement program.”
John Larson added, “We are in a very dynamic time in the healthcare industry’s history and I am excited to be in a position to support the introduction of new products and services. CRF Health is positioned to quickly and accurately support its pharmaceutical Sponsors in all phases of their clinical trials. As the global leader in ePRO technology, setting the trend in the elimination of paper trials will continue to be the mainstream focus. Our cutting edge solutions indirectly influence the global well-being of mankind allowing our Sponsors to bring new treatments to market through the application of robust ePRO standards.”
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Plymouth Meeting, PA – March 4, 2011: CRF Health, a leading global provider of ePRO solutions for the Life Sciences Industry will be joined by industry colleagues at the DIA EuroMeeting for a session on the topic ePRO data collection methods.
The meeting takes place March 28-30, 2011 in Geneva, Switzerland. The title of the session is “Comparing ePRO Technologies: What Works?” The Session Chair will be Ingrid Klingmann, CRF Health, Clinical Advisor. Rauha Tulkki-Wilke, Director Product Management, CRF Health will deliver the introduction which will discuss the rapidly evolving techniques utilized in ePRO technology and provide attendees with an overview of practical considerations for utilizing different ePRO technologies ranging from PDA and mobile phones to tablet PCs and the web. Results from tests with people with a healthcare or technology background and from cognitive and usability interviews with patients in a real-world setting as well as experiences made in clinical trials will be presented and discussed in the session.
In addition to presenting at the session, CRF Health recently presented “Which ePRO Solution is Right for Your Clinical Study” at DIA’s Annual Workshop in Japan for Clinical Data Management in January, and will present at DIA’s annual meeting in June on these topics “Advanced Clinical Monitoring and Data Management with ePRO” and “Web-Based Assessments: The Internet is an Emerging Modality in PRO.”
Mary Briggs, VP Global Sales & Marketing comments, “We are very pleased to present on various global ePRO trends at DIA events in Asia, Europe, and the US in 2011. These events support CRF Health’s objective of educating the pharmaceutical industry on patient reported outcomes, and raising the visibility of ePRO within the clinical trials sector.”
About CRF Health
CRF Health is a global leader in ePRO (electronic patient reported outcomes) solutions for the life sciences industry. Through innovative technology, a thorough understanding of drug development, and mobile computing, CRF Health is driving the change to higher quality outcomes and more efficient paper-free clinical trials.
CRF Health’s ePRO technology has been used in more than 60 countries, on six continents and 68 regional languages, including several regional Indian dialects. CRF Health consistently demonstrates the industry’s highest patient compliance rates, while delivering unrivaled data accuracy and unmatched patient and site acceptance.
Since its founding in 2000, CRF Health continues to provide true global ePRO delivery and service. Headquartered in the US, CRF Health operates its R&D center of excellence in Helsinki, Finland and has offices around the world.
For more information, please visit www.crfhealth.com.
Media Contact
Heather Bilinski, Marketing Coordinator
CRF Health
4000 Chemical Road, Suite 400
Plymouth Meeting, PA 19462
Phone: +1 267.498.2349
Fax: +1 215.565.0001
heather.bilinski@crfhealth.com
Plymouth Meeting, PA – January 11, 2010: CRF Health, a leading global provider of ePRO solutions for the Life Sciences Industry, today announced a series of upcoming conferences that will feature presentations by CRF Health’s ePRO experts.
14th Annual Workshop in Japan for Clinical Data Management – 27-28, January, 2011; Tokyo Japan
- CRF Health has been invited to co-chair the ePRO session as part of the 14th Annual Workshop in Japan for Clinical Data Management sponsored by the DIA. Along with several strategic partner organizations, CRF Health will be speaking on the importance of ePRO in the global clinical research space, specifically focusing on ePRO’s potential to streamline and advance clinical data and overall study outcomes. Gregg Jewett, Sr. Director Strategic Alliances and Partnerships, will co-chair the session. Kai Langel, Sr. Systems Specialist, will present on the topic "Which ePRO Solution is Right for Your Clinical Study?"
ACDM Annual Meeting – 6-8 March, 2011; Whittlebury Hall, Northampton, UK
- John Jordan, Sr. VP of eClinical Technologies will present on the topic “Advanced Clinical Monitoring and Data Management with ePRO.”
APS Annual Meeting – 19-21 May, 2011; Austin, TX
- Bonnie Teschendorf, PhD, PRO Scientific Advisor will present a poster session on the topic “Electronic Pain Assessment Outcomes: Designs Used in Clinical Trials.”
DIA Annual Meeting – 19-22 June, 2011; Chicago, IL
- John Jordan, Sr. VP of eClinical Technologies will present on “Choosing the Right ePRO Solution for Your Clinical Program.”
John Jordan will also present at the Spring eClinical Forum meetings to be held in Europe and North America as well as at the Massachusetts Biotechnology Council event to be held in June 2011.
Mary Briggs, VP Global Sales and Marketing commented “CRF Health’s participation in various industry symposia is an important part of the company's strategy to offer gold standard ePRO education. Not only are the topics timely in moving the ePRO industry forward, but they demonstrate CRF Health’s commitment to further advance paperless trials.”
Plymouth Meeting, PA – December 8, 2010: CRF Health’s advertising campaign, entitled ‘No One Gets You Closer’, which focuses on the collection of clean patient data for use in clinical trials recently received awards at both the CLIO Healthcare Awards and the Rx Awards. The ‘No One Gets You Closer’ ad campaign recreates intimate patient settings to demonstrate CRF Health’s capabilities in the ePRO (electronic patient reported outcomes) arena, and is aimed at healthcare professionals involved in clinical trials.
The campaign received a bronze award at the CLIO Healthcare Awards in the print/corporate communications category, one of only 56 awards delivered at the prestigious awards ceremony held in mid-November in New York City. Considered the ‘Oscars’ of healthcare advertising, the CLIO Healthcare Awards recognize innovation and creative excellence around the globe. Competition in this year’s event was fierce among the 1000 entries from 235 agencies in 27 countries.
CRF Health also received a total of four Rx awards for the ‘No One Gets You Closer’ video campaign. ‘Loo’ and ‘Kissing’ were both awarded silver, while ‘Hoover’ and ‘Bed’ won bronze awards. Founded in 1986, The Rx Club Show honors creativity in pharmaceutical advertising. Judged by a panel of top industry experts, these global awards are an international icon within the healthcare industry. The mission of the Rx Club Show is ‘to provide an independent forum for the worldwide healthcare advertising community to exchange ideas, showcase the best creative projects, and bring forth innovative ideas in the expanding healthcare market place’.
The ad campaign was created by Langland, CRF Health’s advertising agency. Andrew Spurgeon, Langland’s Creative Director explained that, “Once the theme of the campaign was understood we needed to create a unique way to demonstrate CRF Health’s unique ability to, as the campaign title suggests, close the gap between patient and clinical trial professional. The resulting vignettes do that in a clear yet somewhat humorous manner.”
“The idea was to focus on the patient as the source of the data,” said Mary Briggs, Vice President of Global Sales and Marketing. “We put the patient at the heart of the execution. We wanted to create something engaging that captures the essence of what CRF Health is about,” she added. Not only is the campaign unique in this data-driven field, but it also conveys elements of warmth and humor. “We like to show that while we are completely focused on ePRO, we also have a human side, and are a forward thinking company,” said Briggs.