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Pharmaceuticals Pilot #3: Investigation
Executive Summary
SagaPharma™ Pilot 3 Clinical Investigation Management and IND Compliance
The Breakthrough
Pilot 3 delivers a breakthrough solution for one of the pharmaceutical industry’s most critical and time-consuming challenges: secure, compliant, and efficient management of Investigational New Drug (IND) applications and clinical investigations under U.S. 21 CFR Part 312, fully integrated with electronic records (Part 11), GMP batch oversight (Parts 210/211), and biologics requirements (600-series).
The Problem Today
IND submissions and clinical trial management often take months, involving manual compilation of paper or siloed digital records, repeated regulatory queries, and fragmented evidence trails.
Protocol amendments require lengthy review cycles with inconsistent electronic signature and audit trail enforcement.
Linking investigational batches/lots to trial data and public registries (FDAAA 801 / ClinicalTrials.gov) remains manual and error-prone.
Sponsors, CROs, and regulators face high administrative burdens, delayed timelines, and elevated compliance risks, ultimately slowing the delivery of new therapies to patients.
What Pilot 3 Achieves
Pilot 3 introduces a governance-driven framework that is:
Instant & Automated – A sponsor or CRO creates a persistent, on-chain clinical investigation record with linked protocol reference (FDAAA 801 ID) in minutes.
Provably Compliant – Electronic signatures, audit logs, batch/lot linkages, and evidence proofs are immutable and verifiable, enforcing Part 11/312/600-series rules by design.
Community-Governed – Stakeholders (sponsors, regulators, standards bodies) can vote on extensions using lightweight on-chain governance.
Seamlessly Connected – Approved investigations instantly link to GMP batches, biologics lots, and downstream pharmacovigilance/reimbursement bridges, enabling real-time data flows in SagaCoin (PSC).
Real-World Benefits
For Sponsors & CROs
Reduce IND preparation and amendment cycles by 70–80% from months to days or hours, with audit-ready records generated automatically.
Lower compliance costs and risk through enforced invariants (e.g., no trial closure without linked evidence).
Accelerate time-to-market for new drugs and biologics.
For Regulators & Oversight Bodies
Continuous, real-time visibility into investigation status, amendments, and supporting batch data without waiting for periodic submissions.
Cryptographically verifiable audit trails that dramatically simplify reviews and inspections.
For Patients & Public Health
Faster development and approval of innovative therapies due to streamlined processes.
Enhanced safety through immediate linkage of investigational materials to trial outcomes and future pharmacovigilance signals.
For Platforms & Investors
Reduced reconciliation and dispute costs across the R&D pipeline.
New tokenized mechanisms for milestone-based financing tied directly to verifiable clinical proofs.
Projected ecosystem efficiencies contributing to billions in industry-wide savings as adoption scales.
Available now (on public development testnet) for review and testing
Pilots starts in ~90 days
Low-risk, high-impact, and ready for real IND workflows, sponsors, and trial data. We invite pharmaceutical sponsors, CROs, regulatory affairs teams, ethics committees, standards organizations (FDA, EMA, ICH, CDISC, HL7), and investors to:
- Test the pilot with your own protocols and batch records.
- Verify and refine the underlying class tree architecture.
- Co-develop extensions (e.g., full IND form mappings, international equivalents like CTA in EU).
- Take shared custodianship to prepare for global production launch.
More than a technical pilot…
The foundation for a faster, safer, and more transparent clinical development ecosystem.
The pharmaceutical community and investors have a unique opportunity to take custodianship of this transformative class tree.
By verifying the architecture, completing mappings for standards like 21 CFR Part 312, FDAAA 801, and ICH guidelines, and collaborating on refinements, you’ll accelerate a global launch that delivers massive operational efficiencies (e.g., 70–80% faster IND cycles, real-time audits) and patient impact (earlier access to innovative therapies).
This open framework empowers sponsors with compliance-by-design, regulators with continuous oversight, and the entire industry with dispute-free, evidence-linked operations.