Acorn Regulatory Offers EU Programs for U.S. Drug-Device Sponsors
Acorn Regulatory, an ISO-certified medical device and pharmaceutical consulting firm, has customized programs to help U.S. manufacturers of drug-device combinations in meeting European regulatory approvals.
Acorn Regulatory, an ISO-certified medical device and pharmaceutical consulting firm, has customized programs to help U.S. manufacturers of drug-device combinations in meeting European regulatory approvals. Focusing on small to mid-size companies, Acorn Regulatory has put in place a comprehensive step-by-step process that provides the correct regulatory pathway for medical device products that also have a drug component. This process includes training programs that first define the requirements, the steps to obtain CE Mark Certification, post-market responsibilities of manufacturers, national requirements throughout Europe and service as an EU Authorized Representative.
Unlock Commercial Growth through Data-Driven Patient and HCP Insights
May 2nd 2025Leveraging data-driven patient and healthcare provider (HCP) insights, including social drivers of health (SDOH), is essential for life sciences companies to continuously improve patient engagement and commercial success. Mark Rodgers, AVP of Commercial Analytics at Inovalon, discusses how identifying treatment milestones, assessing HCP performance, and segmenting patient populations using SDOH data can drive targeted strategies that improve healthcare outcomes and market access
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
FDA Approves Nipocalimab for the Treatment of Generalized Myasthenia Gravis
April 30th 2025Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.
