inVentiv Health, a global provider of clinical development and comprehensive commercialization services, announced expansion of compliance products and services to assist biopharmaceutical companies conducting non-interventional studies globally.
inVentiv Health, a global provider of clinical development and comprehensive commercialization services, announced expansion of compliance products and services to assist biopharmaceutical companies conducting non-interventional studies (NIS) globally. The announcement is related to changes in the EU Directive governing clinical trials, which takes effect May 2016. inVentiv Health believes the regulation could cause confusion around the conducting of non-interventional trials (also known as observational studies) because of vague regulatory language and establishment of a new category of trial with its own compliance requirements.
The new series of proprietary inVentiv Health resources are now available to address this issue 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.
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.