Avania today said it has acquired medical device clinical research IMARC for an undisclosed amount.
Strongsville, Ohio-based IMARC is a full-service clinical research oversight company that offers monitoring, auditing, safety, data management and training.
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Avania today said it has acquired medical device clinical research IMARC for an undisclosed amount.
Strongsville, Ohio-based IMARC is a full-service clinical research oversight company that offers monitoring, auditing, safety, data management and training.
“At Avania, we are focused on building a high-quality, full-service specialist medical technology CRO with global reach,” Avania CEO Sapna Hornyak said in a news release. “We are delighted to welcome the IMARC team, with whom we have had the pleasure of collaborating for some time. They bring a great commitment to client service and outcomes and allow us to offer our clients additional depth and strength in the United States, complementing our existing global operations perfectly.”
Through the deal, IMARC’s clients will gain access to Avania’s extended international footprint in the EU and Australia. Netherlands-based Avania will also provide its biostatistics, strategic consulting, regulat…
By Jennifer Varela, Senior Manager, Reimbursement at Avania Mack Rubley, Executive Director, Business Development (US) at Avania
Admittedly, requesting reimbursement for investigational device exemption (IDE) clinical trials in the United States is a complex, daunting process frequently overlooked by medical device manufacturers. However, if payers — most notably the U.S. Centers for Medicare and Medicaid Services (CMS) — approve a study for reimbursement, the sponsor can offset a significant percentage of routine healthcare and/or device costs accrued during the clinical trial.
Reimbursement (if any) for IDE studies varies among commercial payers. Payers that do reimburse tend to follow CMS rules and policies around IDE study reimbursement.
Why Apply for CMS Reimbursement?
Without payer reimbursement, sponsors pay 100 percent of healthcare and device costs for all clinical trial participants. For studies that involve an invasive procedure…