ERT Acquires invivodata to Establish the Industry’s Most Experienced Provider of Clinical Outcome Assessment Solutions

ERT Acquires invivodata to Establish the Industry’s Most Experienced Provider of Clinical Outcome Assessment Solutions

PHILADELPHIA, PA, July 9 2012 - ERT, a global technology-driven provider of health outcomes services to biopharmaceutical sponsors and contract research organizations (CROs), announced today the acquisition of  invivodata, Inc, a leading provider of electronic Patient Reported Outcomes (ePRO) solutions and Consulting services, based in Pittsburgh, PA.

The transaction was facilitated by the San Francisco-based private equity group, Genstar Capital, LLC who last week announced that they had completed the acquisition of ERT.  The acquisition immediately positions ERT as a leader in Clinical Outcome Assessments (COA).  The combined organization will now offer sponsors, CROs and other third-party vendors a combination of market-leading electronic patient reported outcomes (ePRO)/COA solutions and scientific and regulatory consulting services that is unrivalled in the industry. The invivodata Consulting group bolsters ERT’s position as the scientific thought leader in Health Outcomes Research and complements its market leading position in Cardiac safety and Respiratory outcomes assessment. The acquisition also enhances ERT’s multi-mode ePRO product portfolio with the introduction of a suite of proven site-based and patient-friendly handheld devices that have already been validated to collect therapy-specific diaries, instruments and assessments.

invivodata reported record growth in 2011, stemming from the addition of over 160 clinical projects.  Three consecutive years of growth in bookings, revenue, and profitability has led the company to substantially increase headcount, enabling it to meet the growing needs of its worldwide customer base.  The market for the collection of clinical outcomes data is set to grow by over 50% in the next three years, according to industry reports, and ERT is ideally positioned to grow in this segment and capitalize on its established track-record of innovation to create value for its sponsors and CRO partners with a suite of clinician and patient-centric solutions.

Dr Jeffrey Litwin, ERT’s CEO, states: “For some time, ERT has been working in collaboration with sponsors and partners to establish a new model of delivering value through the centralization of Health Outcomes data. ERT is a leader in providing cardiac safety and respiratory solutions and, by adding invivodata’s team of scientists and technology experts, we accelerated this strategic initiative, which will provide our joint clients with consistent, scientifically accurate Outcome Assessment data which will be accessible from one platform.We are delighted to welcome the new team aboard.”

“Our dedicated team of employees has worked tirelessly over the past 12 years to build a company that delivers true value to our customers,” commented Doug Engfer, CEO of invivodata. “Becoming a part of ERT will enable us to enhance the value we deliver.  We truly appreciate the trust our customers have placed in us, and we look forward to expanding those relationships with our new colleagues at ERT.”

For further information on ERT and its technology and services, please email info@ert.com, call +1 215 972 0420 or visit www.ert.com

For further press information, please contact Patrick Hughes by email, phughes@ert.com, or phone +44 (0) 7703 532 749.

About ERT

ERT (www.ert.com) is a global technology-driven provider of health outcomes research services supporting biopharmaceutical sponsors and Contract Research Organizations (CROs) to achieve their drug development and healthcare objectives. ERT harnesses leading technology coupled with reliable processes and scientific expertise to collect, analyse and report on clinical data to support the determination of health outcomes critical to the approval, labeling and reimbursement of pharmaceutical products. ERT is the acknowledged industry leader in centralized cardiac safety, respiratory efficacy services, electronic Patient Reported Outcomes (ePRO) and Clinical Outcome Assessment solutions.

About invivodata

invivodata (www.invivodata.com) is a fully-integrated Clinical Outcome Assessments (COA) organization delivering regulatory-proven strategic consulting and practical electronic solutions to biopharmaceutical companies who depend upon patient-centered research.  From reliable and scientifically sound consulting that helps research teams effectively develop, execute, and document COA strategies to electronically collecting COA data in global clinical development programs, invivodata helps its customers strategically use patient, clinician, and observer reported outcomes data (PROs, ClinROs & ObsROs) to support labeling claims, enhance reimbursement strategies, and meet other clinical program objectives. Through partnerships with leading CROs and eClinical technology providers, invivodata seamlessly integrates into the clinical trial ecosystem, helping to minimize operational risk and maximize efficiencies.

About Genstar Capital

Genstar Capital (www.gencap.com) is a leading private equity firm that has been actively investing in high quality companies for more than 20 years. Based in San Francisco, Genstar works in partnership with its management teams and its network of operating executives and strategic advisors to transform its portfolio companies into leading industry businesses. Genstar has more than $3 billion of committed capital under management and targets investments focused on selected sectors within the life science, healthcare services, software and software services, insurance and financial services, and industrial technology industries.

Genstar Capital Completes ERT Acquisition In A Take-Private Transaction

Genstar Capital Completes ERT Acquisition In A Take-Private Transaction

PHILADELPHIA, PA, 3 July 2012 - ERT, a global technology-driven provider of health outcomes services to biopharmaceutical sponsors and contract research organizations (CROs), announced today that Genstar Capital, LLC, has completed its acquisition of the company in a take-private transaction valued at approximately $400 million.

Dr. Jeffrey Litwin, who will continue to lead ERT as CEO, said, “As a private company we will continue to serve our customers and enhance our suite of products. We have been able to grow our company into a global leader, and, with Genstar’s partnership, we will look for creative new ways to grow our business organically and identify new investment opportunities as part of our continued development.”

“ERT is already the global leader in its sector yet we believe the company can benefit from our expertise in the pharmaceuticals industry to create positive change that will drive operations at an increased pace,” said Robert Weltman, Managing Director of Genstar.  “This is a sector we know well, and the added strength of our operating partners and strategic advisory board will help build ERT into a stronger independent platform company. We are eager to work with ERT’s management team to position this compelling company for sustained growth by implementing growth oriented strategic initiatives, including establishing more strategic relationships with customers and identifying new expansion opportunities.”

For further information on ERT and its technology and services, please email info@ert.com, call +1 215 972 0420 or visit www.ert.com

About ERT

ERT (www.ert.com) is a global technology-driven provider of health outcomes research services supporting biopharmaceutical sponsors and Contract Research Organizations (CROs) to achieve their drug development and healthcare objectives. ERT harnesses leading technology coupled with reliable processes and scientific expertise to collect, analyse and report on clinical data to support the determination of health outcomes critical to the approval, labelling and reimbursement of pharmaceutical products. ERT is the acknowledged industry leader in centralized cardiac safety, respiratory efficacy services, electronic Patient Reported Outcomes (ePRO) and Clinical Outcomes Assessment solutions.

About Genstar Capital, LLC

Genstar Capital (www.gencap.com) is a leading private equity firm that has been actively investing in high quality companies for more than 20 years. Based in San Francisco, Genstar works in partnership with its management teams and its network of operating executives and strategic advisors to transform its portfolio companies into industry-leading businesses. Genstar has more than $3 billion of committed capital under management and targets investments focused on selected sectors within the life science, healthcare services, software and software services, insurance and financial services, and industrial technology industries.

Media Contacts

ERT:
Patrick Hughes
Tel: +44 7703 532 749                                      
phughes@ert.com

Genstar:
Chris Tofalli
Chris Tofalli Public Relations
Tel: 914-834-4334

ERT Launches New Website to Support Significant Commercial Growth

PHILADELPHIA, PA, 15 January- ERT, a global technology-driven provider of health outcomes services and customizable medical devices to biopharmaceutical sponsors and Contract Research Organizations (CROs), announced today the launch of a new corporate website to further elevate its market and thought leadership position. Complementing the company’s commercial growth in the last 18 months, web traffic to ERT’s website increased by 41% from June 2010 to October 2011, as visitors sought further detailed information about ERT’s comprehensive range of Cardiac Safety, Respiratory and ePRO solutions. To access the new website, visit www.ert.com.

The newly created website has been designed to reflect ERT’s position as a company offering unrivalled processes and scientific expertise to collect, analyze and report on clinical data. This is done in order to support the determination of health outcomes critical to the approval, labeling and reimbursement of pharmaceutical products.

Created to provide a new online customer experience, the website provides enhanced content and improved navigation in order to give visitors a more comprehensive and in-depth understanding of ERT’s services and expertise in the health outcomes research field. Providing in depth information on ERT’s distinctive cardiac safety, respiratory and ePRO solutions, visitors are also able to learn about ERT’s clinical consulting services, which offer essential scientific and regulatory expertise in order to ensure quality trial data.

ERT’s commitment to making valuable resources available to patients and clients is fully realized by the new website. Leveraging the research of ERT’s experts and other thought leaders, the site offers a resource center that provides continually updated links to articles, white papers and webinars, in addition to up-to-date news stories. Featuring images and quotes from both junior and senior staff throughout the website, the new aesthetic enables users to see the human side of ERT and familiarize themselves with the experts and dedicated staff that support their research every day.

John Blakeley, Chief Commercial Officer, comments: “Our traditional markets are changing and we felt strongly that a new online presence was needed to better support our Sponsors and our CRO partners. This new site provides a valuable resource center that allows relevant stakeholders to access industry specific information and case studies.”

For further information on ERT and its technology and services, please email info@ERT.com, call +1 215 972 0420 or visit www.ERT.com
For further press information, please contact Fiona Robinson, the Scott Partnership, 1 Whiteside, Station Road, Holmes Chapel, Cheshire CW4 8AA, United Kingdom. Phone +44 1477 539 539, Fax +44 1477 539 540, Email ert@scottpr.com

About ERT

ERT (www.ert.com) is a global technology-driven provider of health outcomes research services and customizable medical devices supporting biopharmaceutical sponsors and Contract Research Organizations (CROs) to achieve their drug development and healthcare objectives. ERT harnesses leading technology coupled with unrivalled processes and scientific expertise to collect, analyse and report on clinical data to support the determination of health outcomes critical to the approval, labelling and reimbursement of pharmaceutical products. ERT is the acknowledged industry leader in centralized cardiac safety and respiratory efficacy services and also provides electronic Patient Reported Outcomes (ePRO)and Outcomes Assessments for multiple modalities across all phases.

ERT and UCLA Initiate Innovative Pilot Program for Chronically Ill Patients

More than 150 patients with COPD will receive additional health care services to improve their health and lower the costs of long term care.

Program will test the benefits of remote monitoring services on a needy and growing population.

PHILADELPHIA, February, 2012- ERT, a global technology-driven provider of health outcomes services and customizable medical devices to biopharmaceutical sponsors and Contract Research Organizations (CROs), announces the launch of the CLEAR Study. Conducted in collaboration with UCLA, the study is an innovative program to help patients suffering from Chronic Obstructive Pulmonary Disease (COPD). COPD is a leading and increasingly prevalent disease which, according to the World Health Organization, will become the world’s third most common cause of death by 2020.

COPD is a progressive and chronic inflammatory disease of airways that typically occurs in middle-aged and older patients. There is no cure for COPD, only therapies that manage the symptoms and seek to prevent acute and debilitating events such as pulmonary exacerbations. These exacerbations are an important cause of disability and further decrease in lung function, which typically require medical therapy at the home or in the hospital. Therefore, early identification and prevention of exacerbations are important, can improve the quality of life of the patients, and can delay or decrease the demand for expensive medical care.

To identify symptoms and concerns early, ERT and UCLA will be providing enhanced services to help the patients outside the physician’s office and beyond the normal process of care. The twelve month study is specifically designed to test whether remote health monitoring:
• Is feasible in patients with moderate-severe COPD
• Improves treatment adherence, symptoms, activity level and quality of life and enables early detection of COPD exacerbations, facilitating early interventions and reducing health related expenditures
The program will operate as a randomized study for patients over 40 years old receiving their care in the Los Angeles community. The program brings together home based spirometry, activity monitoring, adherence scoring, and self-reported symptom monitoring, all enabled through technology. On a daily basis in the patient’s home, enrollees will track their lung function using ERT’s SpiroPro® which will also record symptoms through questions of the CLEAR Sx Assessment instrument. Symptoms, such as breathlessness and cough, will be tracked on the SpiroPro using a novel series of screens adapted from previously reported instruments for the detection of exacerbations. The devices will also deliver the new CLEAR Rx and CLEAR Ex Assessment instruments to determine prescription adherence and perceived activity levels. Every day, enrollees will record their physical activity levels, such as the number of steps taken per day and total activity time, using a wearable accelerometer. All patient data will be securely uploaded to a web based data tracking site where trends in symptoms and concerns with patient status can be quickly identified and addressed through clinical care.

“The breadth of services is a truly unique and innovative design for respiratory care”, notes John Sory, ERT’s Chief Development Officer. “The combined efforts of UCLA and ERT will test new approaches and could well deliver a meaningful new approach for the benefit of patients where the burden of illness is high, the need for quick intervention apparent, and the demand for new forms of care increasingly acute.”

“COPD is a serious illness and early intervention can be critical in improving COPD patients’ quality of life. We welcome the opportunity to work with ERT in helping to remotely monitor patients on a daily basis in their own homes, which may help promptly identify health problems and ensure treatment adherence. Such monitoring may prove to be an important component in the future of healthcare delivery,” said Dr. Christopher Cooper, the study’s principal investigator and professor of medicine and physiology at the David Geffen School of Medicine at UCLA.

The first of over 200 patients are expected to be recruited starting in February, 2012 and patient outcomes will be reported in late 2013. Enrollees will have full physical exams upon enrollment and at the test conclusion. Throughout the period, the metrics to be tracked will include:

• Adoption rates of remote health monitoring
• Treatment adherence in terms of percentage of days prescribed treatment is taken
• Time to first COPD exacerbation as defined by standard criteria and number of exacerbations per year including the proportion of subjects experiencing one or more exacerbations
• Respiratory function values such as mean daily forced expiratory volume in one second (forced spirometry), inspiratory capacity (slow spirometry), and pulse oximetry (SPO2)
• Daily activity level and symptom scores
• Utilization information such as number of physician visits, emergency department visits, hospitalizations, number of days spent in hospital, and inferred health care costs

Dr. Jeffrey Litwin, President and CEO of ERT concluded, “We are excited to work with Dr Cooper and his colleagues at UCLA to help progress the adoption of remote healthcare monitoring and we look forward to learning and sharing the results of this important trial”.

For further information on ERT and its technology and services, please email info@ERT.com , call +1 215 972 0420 or visit www.ERT.com

For further press information, please contact Laura Browne, the Scott Partnership, 1 Whiteside, Station Road, Holmes Chapel, Cheshire CW4 8AA, United Kingdom. Phone +44 1477 539 539, Fax +44 1477 539 540, Email ert@scottpr.com

About UCLA

The David Geffen School of Medicine at UCLA is an internationally recognized leader in research, medical education and patient care. The school has more than 2,000 full-time faculty members, almost 1,300 residents, more than 750 medical students and roughly 400 Ph.D. candidates.
About ERT

ERT (www.ert.com) is a global technology-driven provider of health outcomes research services and customizable medical devices supporting biopharmaceutical sponsors and Contract Research Organizations (CROs) to achieve their drug development and healthcare objectives. ERT harnesses leading technology coupled with unrivalled processes and scientific expertise to collect, analyse and report on clinical data to support the determination of health outcomes critical to the approval, labelling and reimbursement of pharmaceutical products. ERT is the acknowledged industry leader in centralized cardiac safety and respiratory efficacy services and also provides electronic Patient Reported Outcomes (ePRO)and Outcomes Assessments for multiple modalities across all phases.

ERT Appoints Linda Deal Head of Health Outcomes Research

PHILADELPHIA, PA, 24 August 2011- ERT, a global technology-driven provider of clinical services and customizable medical devices to biopharmaceutical and healthcare organizations, announced today the appointment of Linda Deal to lead ERT’s Health Outcomes Research initiatives.  This strategic appointment extends ERT’s commitment to health outcomes research and augments its Patient Reported Outcomes capabilities and multi modality product offering with deeper scientific expertise.

Jeffrey Litwin MD, President and CEO of ERT comments, “Linda’s expertise and extensive industry knowledge will assist us in increasingly providing innovative outcomes research solutions to better serve our clients’ developing needs. Having worked inside sponsor organizations and across a number of entities within the PRO community, Linda brings insight and perspective on the creation and implementation of Patient, Clinician and Observer reported outcomes.  Her domain knowledge will enable her to add considerable value to ERT’s offerings and to our clients.”

Ms Deal brings a breadth of experience in health outcomes and in the development and validation of patient reported assessments.  Most recently she was the Immunology Patient Reported Outcomes (PRO) Lead at Janssen Pharma, a division of Johnson & Johnson, where she was responsible for developing and integrating the PRO strategy within the end to end development process. Prior to Johnson & Johnson, Linda was head of the PRO Center in Global Health Outcomes Assessment (GHOA) at Wyeth Research, now Pfizer.  She has also supported health economics and outcomes research for Wyeth, Research Triangle Institute, and Glaxo Welcome. 

Over her career, she has designed a number of assessments used in clinical trials today and has prepared over 20 regulatory briefing documents addressing PRO development and validation for supporting registration and labeling.  She now brings this wealth of experience and expertise to benefit ERT’s clients. 

In the context of health outcomes research ERT’s multi modality ePRO solutions offer the advantages of simplicity, mobility and immediacy of use over traditional paper-based methods. The company offers its customers truly independent solutions and advice providing the appropriate ePRO modality considering the complexity, length, site location, patient population, budget and size of trial.  ERT’s ePRO suite comprises an IVR solution (VIAPhone®), a digital pen (VIAPen®), a handheld device (VIAPad®) and an internet application (VIAWeb®). 

For further information on ERT and its technology and services, please email info@ERT.com , call +1 215 972 0420 or visit www.ERT.com

For further press information, please contact Neil Drake, the Scott Partnership, 1 Whiteside, Station Road, Holmes Chapel, Cheshire CW4 8AA, United Kingdom.  Phone +44 1477 539 539, Fax +44 1477 539 540, Email ert@scottpr.com  

About ERT

ERT (www.ert.com) is a global technology-driven provider of clinical services and customizable medical devices to biopharmaceutical and healthcare organizations.  It is the market leader for centralized cardiac safety and respiratory efficacy services in drug development and also collects, analyzes and distributes electronic Patient Reported Outcomes (ePRO) in multiple modalities across all phases of clinical research.

Statements included in this release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve a number of risks and uncertainties, which could cause actual results to differ materially from those expressed or implied from such statements. These risks and uncertainties include, without limitation, the Company’s ability to obtain new contracts, variability in size, scope, and duration of projects, integration of acquisitions, competitive factors, technological development, market demand, and other factors described in the Company’s filings with the Securities and Exchange Commission.  The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

ERT Appoints Robert Kleiman MD to Chief Medical Officer

PHILADELPHIA, PA – 21 June, 2011 ERT, a global technology-driven provider of clinical services and customizable medical devices to biopharmaceutical and healthcare organizations, announced today that Robert Kleiman, M.D.  has been appointed to the role of Chief Medical Officer in addition to his current role as Vice President of Global Cardiology.

Dr. Kleiman graduated from Brown University Medical School with residency in Internal Medicine and completed Fellowships in Cardiology and Cardiac Electrophysiology at the University of Pennsylvania. Prior to joining ERT as a full time employee in April 2004, Dr. Kleiman had worked for ERT as an independent contractor through his cardiology and cardiac electrophysiology practice since 1994.  Dr. Kleiman has managed ERT’s cardiology group, which has more than tripled in size since 2004, while maintaining ERT’s standards for high quality and consistency.

ERT Announces Appointment of New President and CEO

PHILADELPHIA, PA – 04 May, 2011 ERT, a global technology-driven provider of clinical services and customizable medial devices to biopharmaceutical and healthcare organizations, announced today that its Board of Directors has appointed Jeffrey S. Litwin, M.D. its new President and Chief Executive Officer and as a member of the board.

Dr. Joel Morganroth, who had served as interim President and Chief Executive Officer, commented that "after a thorough national search by Heidrick and Struggles, our Board selected Dr. Litwin, an internal candidate, as the most qualified person to lead ERT.  Jeff brings to ERT knowledge of the Clinical Research domain, that is our core business, and also experience in the adjacent markets of Phase IV safety surveillance and healthcare in which ERT's assets will be employed.  All of our employees look forward to continuing to work with Jeff to enhance ERT's operational successes and strategy."

Dr. Litwin joined ERT in 2000 as Senior Vice President and Chief Medical Officer and was subsequently promoted in December 2005 to Executive Vice President and Chief Medical Officer.  Dr. Litwin oversaw ERT's global cardiac safety operations for seven years and was instrumental in implementing EXPERT, ERT's digital operating system.  During this time period, ERT experienced tremendous growth with revenues increasing more than three-fold. For the last four years, he has been responsible for leading ERT's consulting business, assisting over 150 companies with the design and evaluation of cardiac safety testing programs.  Throughout his career at ERT, Dr. Litwin has also been directly involved in supporting ERT's sales efforts.