05.18.15
inVentiv Health has expanded its compliance services to assist biopharma companies conducting non-interventional studies (NIS) or observational studies, in 52 countries around the world. Clients of the new services will have access to an NIS Regulatory Intelligence Database aimed at clarifying the new EU regulation No 536/2014, scheduled to take effect in May 2016.
Vague regulatory language around the new regulation is expected to cause confusion about the conduct of non-interventional trials, 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 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."
The new services will address Regulatory Affairs, Medical Affairs, QA Auditing, Project Management, Pharmacovigilance, as well as the design or conduct of NIS requiring detailed, country-level information to assure compliance.
Vague regulatory language around the new regulation is expected to cause confusion about the conduct of non-interventional trials, 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 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."
The new services will address Regulatory Affairs, Medical Affairs, QA Auditing, Project Management, Pharmacovigilance, as well as the design or conduct of NIS requiring detailed, country-level information to assure compliance.
