INNOVATION ACTA SRL

Their core work

Innovation Acta is a Siena-based Italian SME that provides clinical research and regulatory support services for advanced therapeutic medicinal products (ATMPs) and clinical trials in the health sector. They contribute to multinational clinical studies as a specialist partner handling trial design, patient stratification, regulatory compliance, and cost-effectiveness analysis. Their project portfolio spans liver disease, autoimmune conditions, cell therapies, and host-directed medicine, consistently appearing in large EU consortia focused on translating research into clinical practice.

What they specialise in

How they've shifted over time

Innovation Acta's early H2020 work (2017-2018) centered on liver disease therapeutics and placenta-derived cell therapies for orthopaedic recovery — relatively conventional clinical trial support. From 2019 onward, their focus shifted decisively toward immunomodulation and advanced therapies: regulatory T cells, CRISPR/Cas9-based gene delivery, autoimmune disease endpoints, and host-directed antifungal medicine. This progression shows a clear move from traditional pharmacological trials toward the frontier of cell and gene therapy clinical development.

Innovation Acta is moving deeper into ATMP clinical development — particularly regulatory T cell engineering and immunomodulation — positioning them as a go-to clinical partner for next-generation biological therapies entering trials.

How they like to work

Innovation Acta operates exclusively as a consortium partner, having never coordinated any of its 9 H2020 projects. They work in large, multinational consortia — 113 unique partners across 21 countries — which suggests they are sought after as a reliable specialist contributor rather than a project leader. Their presence across diverse therapeutic areas indicates flexibility and a service-oriented model, likely offering clinical research infrastructure that different research teams can plug into.

Extensive European network spanning 113 unique consortium partners across 21 countries, built through participation in large multi-center clinical trials. Despite being a small Italian SME, their collaborative footprint is pan-European with no apparent geographic concentration.

What sets them apart

Innovation Acta fills a specific gap: they are a private SME providing clinical trial and regulatory expertise for advanced therapies within academic-led EU consortia. While most ATMPs research partners are universities or hospitals, this company brings a private-sector perspective on trial management, cost-effectiveness, and implementation strategy. Their Siena base — a historic center of biomedical research in Italy — and their ability to work across multiple therapeutic areas make them an adaptable partner for any consortium needing clinical development support.

Highlights from their portfolio

• RESHAPE
  Largest single funding (EUR 426K) involving frontier technologies: CAR-Treg, TCR-Treg, CRISPR/Cas9, and human-on-the-chip — representing their most advanced therapeutic area.
• RESTORE
  Highest EC contribution (EUR 587K) as a CSA project focused on advanced therapies ecosystem coordination, signaling their role in shaping the ATMP regulatory landscape.
• NECESSITY
  Multi-arm multi-stage clinical trial for Sjögren's syndrome with innovative patient stratification — demonstrates sophisticated trial design capabilities.