Resources
In this episode, Rich Gliklich, MD unpacks the FDA’s new draft guidance, Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products. Aimed at enhancing long-term safety and efficacy monitoring, the guidance focuses on: The importance of long-term follow-up Cautioning on the use of typical real-world data sources such as medical[…]
Client Challenges Chronic peripheral nerve pain is debilitating, costly, and often unresponsive to conventional therapies. While Nalu Medical’s Peripheral Nerve Stimulation (PNS) System has shown strong clinical promise as a minimally invasive, drug-free approach to pain management, payer reimbursement of PNS therapies is limited by a lack of clear evidence demonstrating its economic value. To[…]
Register >> October 8th, 12pm EDT Conducting real-world research in rheumatology is challenging. Patients often present with multiple comorbidities, disease measures are inconsistently captured in routine care, and traditional data sources don’t always reflect full patient journeys across specialties. In this webinar, OM1 experts will share how AI-enabled, multi-source real-world data can help overcome these[…]
Read the full press release >> Aug 21, 2025 9:00 AM Eastern Daylight Time BOSTON & SAN FRANCISCO–(BUSINESS WIRE)–OM1, a leader in real-world evidence (RWE) generation and AI-driven insights for healthcare and life sciences, today announced that its Rheumatoid Arthritis (RA) specialty dataset achieved the highest quality score in an independent, AI-powered evaluation conducted by[…]
Read the press release >> Aug 12, 2025 9:00 AM Eastern Daylight Time BOSTON–(BUSINESS WIRE)–OM1, a leader in real-world evidence (RWE) generation and AI-driven insights for healthcare and life sciences, today announced the expansion of its Neurology Specialty Network with the addition of 500,000 patients. The network now includes over 3 million individuals with electronic[…]
