(Burlington, Mass.) -- inVentiv Health, Inc., offering best-in-class clinical, commercial, and consulting services to the healthcare industry, today announced that it has taken an equity stake in Mytrus, Inc., a pioneer in "virtual clinical trials" and technologies such as electronic informed consent to improve trial efficiency.
Mytrus has been expanding the boundaries of traditional clinical trial research with the first all-electronic, home-based clinical trial to gain U.S. Food and Drug Administration approval and IRB (Institutional Review Boards). inVentiv Health is taking a significant equity stake in Mytrus, as well as establishing a strategic commercial relationship.
"This partnership blends our shared drive for innovation and our complementary experience from the world of high tech and clinical research," said Paul Meister, Chief Executive Officer of inVentiv Health. "The goal is improved trial execution, accelerated time to market and reduced product development costs for our clients."
Mytrus technology allows sponsors to use electronic informed consent, a significant improvement in efficiency and speed. It allows a wider range of people to participate in clinical research by removing location as an obstacle to recruitment and bringing trials directly to participants in their homes. Taken together, Mytrus technology enables more cost-effective clinical studies that start and finish faster. At a time when bringing a drug to market can cost up to $1 billion, Mytrus provides solutions for pharmaceutical and device makers eager to find more cost effective ways to conduct research.
"We estimate that up to 30% of studies run today could be done direct-to-patient and 100% of studies and study patients could benefit from electronic informed consent," said Anthony Costello Co-founder and CEO of Mytrus. "inVentiv Health has the global footprint and clinical research expertise to help us bring the benefits of our technology more quickly to trial sponsors and patients worldwide."
Patients who match the eligibility criteria for a study can live anywhere and submit their data remotely, allowing sponsors to conduct more cost-effective recruitment campaigns and making participation more convenient for patients and physician-investigators. Sponsors are able to reduce the number of study sites required to run a clinical trial by as much as 80 percent, which dramatically increases savings in time and costs throughout the trial, especially during the study start up phase.
"Reducing the overall cost of clinical trials and increasing patient recruitment remain serious issues for sponsors," said Ray Hill, President of inVentiv Health Clinical. "Our partnership with Mytrus will allow us to recruit and retain a broader base of patients more quickly to help meet our clients' needs."
About inVentiv Health Clinical
inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies, offering therapeutically specialized capabilities for Phase I-IV clinical development, bioanalytical services, and strategic resourcing from a single clinical professional to an entire functional team. With 7,000 passionate employees in more than 36 countries, inVentiv Health Clinical works to accelerate high quality drug development programs of all sizes around the world. For more information, visit http://www.inventivhealthclinical.com.
About inVentiv Health
inVentiv Health, Inc. is a leading global provider of best-in-class clinical, commercial and consulting services to companies seeking to accelerate performance. inVentiv offers convergent services that deliver extraordinary outcomes to clients whose goal is improving human life. In 40 countries around the world, inVentiv's 13,000 employees help clients rapidly transform promising ideas into commercial reality. inVentiv clients include more than 550 pharmaceutical, biotech and life sciences companies, as well as companies that now see health as part of their mission. inVentiv Health, Inc. is privately owned by inVentiv Group Holdings, Inc., an organization sponsored by affiliates of Thomas H. Lee Partners, L.P., Liberty Lane Partners and members of the inVentiv management team. For more information, visit http://www.inventivhealth.com.
Forward Looking Statements for inVentiv Health
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks that may cause our performance to differ materially. These forward-looking statements reflect our current views about future events and are subject to risks, uncertainties and assumptions. We wish to caution readers that certain important factors may have affected and could in the future affect our actual results and could cause actual results to differ significantly from those expressed in any forward-looking statement. Such factors include, without limitation: the impact of our substantial level of indebtedness on our ability to generate sufficient cash to fulfill our obligations under our existing debt instruments or our ability to incur additional indebtedness; the impact of the consummation of any announced and future acquisitions; the impact of any change in our ratings and the ratings of our debt securities on our relationships with customers, vendors and other third parties; the impact of any additional leverage we may incur on our ratings and the ratings of our debt securities; our ability to sufficiently increase our revenues and maintain or decrease expenses and cash capital expenditures to permit us to fund our operations; our ability to continue to comply with the covenants and terms of our senior secured credit facilities and to access sufficient capital under our credit agreement or from other sources of debt or equity financing to fund our operations; the impact of any default by any of our credit providers; our ability to accurately forecast costs to be incurred in providing services under fixed price contracts; our ability to accurately forecast insurance claims within our self- insured programs; the potential impact of pricing pressures on pharmaceutical manufacturers from future healthcare reform initiatives or from changes in the reimbursement policies of third-party payers; our ability to grow our existing client relationships, obtain new clients and cross-sell our services; the potential impact of financial, economic, political and other risks, including interest rate and exchange rate risks, related to conducting business internationally; our ability to successfully operate new lines of business; our ability to manage our infrastructure and resources to support our growth; our ability to successfully identify new businesses to acquire, conclude acquisition negotiations and integrate the acquired businesses into our operation, and achieve the resulting synergies; the resolution of purchase price adjustment disputes in connection with our recent acquisitions and related impacts; any disruptions, impairments, or malfunctions affecting software as well as excessive costs or delays that may adversely impact our continued investment in and development of software; the potential impact of government regulation on us and on our client base; our ability to comply with all applicable laws as well as our ability to successfully implement from a timing and cost perspective any changes in applicable laws; our ability to recruit, motivate and retain qualified personnel, including sales representatives; the possibility that client agreements will be terminated or not renewed; any potential impairment of goodwill or intangible assets; consolidation in the pharmaceutical industry; changes in trends in the healthcare and pharmaceutical industries or in pharmaceutical outsourcing, including initiatives by our clients to perform services we offer internally; the impact of customer project delays and cancellations; our ability to convert backlog into revenue; the potential liability associated with injury to clinical trial participants; the actual impact of the adoption of certain accounting standards; and our ability to maintain technological advantages in a variety of functional areas, including sales force automation, electronic claims surveillance and patient compliance. Holders of our debt instruments are referred to reports provided to investors from time to time and the offering memoranda provided in connection with the issuance of our notes for further discussion of these risks and other factors.
Founded in 2009, Mytrus is a privately held e-clinical technology company specializing in patient-centered electronic informed consent and data collection tools. After receiving the first FDA approvals for remote electronic consent and virtual data collection, Mytrus has gone on to develop new technologies for patients including ePRO and EDC tools usable from home and mobile devices, bio-sample consent tracking technology, site training and e-learning applications, and patient home dashboards for tracking clinical study progress and data. Mytrus also holds an exclusive patent for conducting virtual clinical trials in the US. Mytrus investors include BioClinica and inVentiv Health.