inVentiv Health expands global regulatory, compliance services for non-interventional studies
Global CRO inVentiv Health has expanded its compliance products and services to assist biopharmaceutical companies conducting non-interventional studies (NIS) 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 (E.U.) implements the first major change in clinical trial regulation in 15 years. The new regulation, adopted last year and scheduled to take effect in May 2016, repeals a previous E.U. 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 E.U. country to review and alter existing national regulations to assure alignment with E.U. 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 E.U. 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 now are 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.
- NIS Considerations Reports bring together in a single 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."