MedaSystems builds an AI-driven SaaS workflow platform for Expanded Access (EA), Post-Trial Access, and Investigator-Initiated Studies (IIS). Its GxP-compliant application centralizes collaboration among physicians, pharmaceutical companies, CROs, and regulatory partners to expedite requests, treatment delivery, and real-world data capture for regulatory submissions. The platform provides in-app physician request management, workflow automation, partner integration, and centralized tracking to reduce administrative burden. MedaSystems positions Expanded Access and physician-led studies as emerging sources of critical real-world data to support drug development and label expansion. The company is based in Menlo Park, Calif. It says the recent funding will advance new AI-driven platform capabilities and enable automation of other domain-critical life‑sciences workflows. MedaSystems operates a purpose-built SaaS pharma physician network that connects sponsors, medical affairs, clinical operations, regulatory and shipping teams with physicians to provide patients access to investigational, pre-approval medicines. The platform streamlines collaboration and rapid processing of treatment inquiries while enabling capture of de-identified real-world data and flexible workflows for programs such as Expanded/Managed Access, Post-Trial Access, and Investigator-Initiated Study requests. Sponsors gain processing speed and efficiency, improved real-world data capture to inform drug discovery and regulatory submissions, and the ability to run multiple patient-access programs on the same platform. Physicians can rapidly submit applications on behalf of patients, coordinate with staff and pharmacists, track inquiry status and treatment updates, and reduce workload. The company announced completion of a seed funding round from strategic angel and healthtech investors. CEO Fiona Smythe said the funds will support real-world data capture, automation, and machine learning capabilities. MedaSystems is a Menlo Park, Calif.–based digital health software company that has developed a networked platform for collaboration on Expanded Access requests. The platform connects pharmaceutical manufacturers and healthcare providers to manage Expanded Access (also known as Managed Access or Compassionate Use) requests. It enables pharmaceutical companies to respond to requests faster and more efficiently, design more effective clinical trials, enhance pre-approval regulatory submissions, and capture real-world data. Expanded Access allows patients with serious or life-threatening conditions who have exhausted the standard of care and are not eligible for clinical trials to request investigational therapies. The pathway played an essential role during the Covid-19 pandemic and has historically been important for patients with conditions such as cancer, ALS, Alzheimer’s disease, and thousands of rare diseases. The company raised $1.5M in a pre-seed funding round led by nina capital alongside strategic angel investors.

Total raised

$2M

Funding rounds

3

Latest round

Seed

Latest activity

Mar 2022