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inVentiv Health Expands Global Regulatory and Compliance Services For Pharmaceutical Companies Conducting Non-Interventional Studies

Essential Compliance Services Provide Regulatory Teams with Expert Consulting, Deep Data on 52 Nations, Individual Country Reports, Database Access and E-Learning

Princeton, NJ – May 15, 2015 – inVentiv Health, a global provider of best-in-class clinical development and comprehensive commercialization services, today announced a significant expansion of compliance products and services to assist biopharmaceutical companies conducting non-interventional studies (NIS) in any of 52 countries around the world. Clients of the new services will have access to an NIS Regulatory Intelligence Database, the first of its kind.

The announcement comes one year before the European Union (EU) implements the first major change in clinical trial regulation in 15 years. The new regulation - EU No 536/2014, adopted last year and scheduled to take effect in May 2016 - repeals a previous EU Directive governing clinical trials.

The new regulation is expected to spark considerable confusion around the conducting of non-interventional trials (also known as observational studies). The confusion is likely to arise over the many questions remaining around vague regulatory language, as well as the need for every EU country to review and alter existing national regulations to assure alignment with EU regulation. The new regulation also creates an entirely new category of trial with its own compliance requirements.

The complexity of the regulatory landscape in Europe over the next few years requires that companies take measures now to prepare. Organizations that expect and prepare for a regulatory environment in flux will be more likely to marshal their resources, call in experts and be aware of the specific, potential pitfalls to be avoided. inVentiv Health’s compliance services is an essential resource in such preparation.

“The impending regulatory change is happening at the very moment when real-world data from non-interventional studies has never been more important,” said Lynn Okamoto, Executive Vice President of Late Stage, inVentiv Health Clinical Division. “Data obtained from patients in real-life conditions is now essential for building the evidence required by payers for payment and reimbursement decisions.”

Okamoto said inVentiv Health’s new compliance offering should be an enormous asset for pharmaceutical companies navigating changing EU law.

The new services will be of use to pharmaceutical company executives working in Regulatory Affairs, Medical Affairs, QA Auditing, Project Management, Pharmacovigilance or anyone involved in the design or conduct of non-interventional studies (NIS) who require detailed, country-level information to assure compliance and reduce business risks.

A series of proprietary inVentiv Health resources are now available and include:

  • NIS Regulatory Intelligence Database contains links to all regulations and guidelines, submission document templates, data on regulatory bodies, as well as visual process maps and much more – the first of its kind.
  • NIS Considerations Reports bring together in a single, essential document the many regulations and guidelines that govern the conduct of non-interventional studies in a particular country. The reports are delivered by both smartphone app and bimonthly newsletters. Each report includes:
    • Study Start-up: Identifies the regulatory requirements for each type of non-interventional study classification applicable to a country, including approval and notification requirements, document templates, submission documents, approval timeframes, data privacy and financial transparency requirements.
    • Study Conduct: Provides details on informed consent, monitoring, safety reporting, routine notifications to regulatory bodies, biosampling, biobanking and genetic analysis.
    • Study Closure: Provides details on who to notify, when and how and archiving requirements.
  • E-Learning modules help companies assure that teams are suitably “qualified, trained and experienced” to do any job related to the design or conduct of non-interventional studies. The trainings explain, by country, what regulations have changed or are changing, regulatory classification, regulatory framework/applicable legislation and guidelines, approval requirements, responsible parties, industry best practices and a great deal more.

“Confusion over new regulation makes it increasingly difficult to satisfy the first order of regulatory compliance: knowing the rules with which you need to comply,” said Stuart McCully, Vice President, Late Stage Support Services, inVentiv Health Clinical Division. “How a study is classified directly and significantly impacts which regulations must be followed, so getting this right is essential for research sponsors, financially and legally.”

McCully will be available to answer questions about the expanded services later this week at the 20th Annual Meeting of ISPOR, the International Society for Pharmacoeconomics and Outcomes Research in Philadelphia.

About inVentiv Health
inVentiv Health is a global provider of best-in-class clinical development and comprehensive commercialization services, seamlessly linking the capabilities of a leading, global Clinical Research Organization (CRO) with a unique Contract Commercial Organization (CCO). inVentiv Health helps clients improve performance, reduce risk and speed much-needed therapies to market. With 13,000 employees providing services to clients in 70 countries, our global scale and broad expertise make us an attractive strategic partner for companies developing and delivering medicines in a complex operating, regulatory and reimbursement environment. Our clients include more than 550 life sciences companies, including all 20 of the largest biopharmaceutical companies in the world. 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.

inVentiv Health brings business strategy to science and scientific expertise to business for the better treatment of patients worldwide. For more information, visit http://www.inVentivHealth.com.

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 customer project delays, cancellations and terminations and our ability to sufficiently increase our revenues and manage expenses and capital expenditures to permit us to fund our operations; the impact of any future acquisitions; the impact of any change in our current credit ratings or 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 continue to comply with the covenants and terms of our debt instruments 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 on pharmaceutical manufacturers, including pricing pressures, from 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, including through outsourced service providers; our ability to successfully identify new businesses to acquire, conclude acquisition negotiations and integrate the acquired businesses into our operations, and achieve the resulting synergies; 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 clients; our ability to comply with all applicable laws as well as our ability to successfully adapt to any changes in applicable laws on a timely and cost effective basis; our ability to recruit, motivate and retain qualified personnel; the impact of impairment of goodwill and intangible assets and the factors leading to such impairments; 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; our ability to convert backlog into revenue; the potential liability associated with injury to clinical trial participants; the 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.

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