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Among benefits, Expanded Access software can reportedly help design more effective clinical trials and capture RWD
MedaSystems, a digital health software company, has completed a $1.5 million pre-seed funding round led by health tech venture capital fund Nina Capital—alongside a group of angel investors—to build out MedaSystems’ Expanded Access software.
The platform allows patients with a serious or life-threatening condition, who have exhausted the standard of care and are not eligible to participate in clinical trials, to request access to investigational therapies that are yet to gain authorization from local regulatory authorities. Expanded Access has played a role in developing novel treatments during the COVID-19 pandemic and has assisted patients with conditions such as cancer, ALS and Alzheimer's disease.
Essentially, pharma manufacturers and healthcare providers can collaborate on Expanded Access (also known as Managed Access or Compassionate Use) requests. Pharma companies—the software firm says—will be able to respond to Expanded Access requests in a more efficient manner, design more effective clinical trials, further enhance pre-approval regulatory submissions and capture real-world data (RWD).
“We're thrilled to have our new partners on board for this exciting journey, supporting our goal of creating software to make life-saving treatments more broadly and easily available and supporting research and development of new therapies,” says Fiona Smythe, CEO of MedaSystems. “The funds will enable MedaSystems to expand its product and engineering teams, and speed the build out of its physician portal and RWD gathering capabilities.”