CRO inVentiv Health is amping up its capacity in regulatory compliance to prepare for changes in European trial rules, unveiling a global database it claims can help sponsors avoid costly confusion.
European regulators are preparing to roll out some sweeping changes to the governance of so-called non-interventional studies (NIS), in which patients are observed in routine treatment outside of a controlled clinical trial. The shift will create overlapping rules and regulations around the continent, inVentiv said, likely creating confusion about how to classify studies and comply with the law.
With that in mind, inVentiv has launched the NIS Regulatory Intelligence Database, a compendium of regulations spanning 52 countries. The offering is the first of its kind, according to the CRO, pooling vital regulatory information from around the world to mitigate the inherent risks in running global trials.
"The impending regulatory change is happening at the very moment when real-world data from non-interventional studies has never been more important," inVentiv Executive Vice President Lynn Okamoto said in a statement. "Data obtained from patients in real-life conditions is now essential for building the evidence required by payers for payment and reimbursement decisions."
InVentiv, a privately held CRO conglomerate, has been steadily growing its global reach and expertise over the past few years. The company touts itself as playing a role in either the development or commercialization of 60% of all drugs approved by the FDA over the last 5 years. The sprawling company has offerings spanning all phases of clinical development, along with legal, regulatory and policy work, among other services.
- read the statement