InSplice AI
Build Custom Life-Science Research LLMs
Turn fragmented trial data into actionable insights through custom Research AI Agents armed with live, compliant data—accelerating cures for patients.
Proprietary in-transit data healing & governance—no data lake required.
InSplice offers…
On-Demand AI-Ready Data
InSplice delivers continuous, unified streams of governed trial data for immediate LLM reference and processing.
Dramatic Reduction in Manual Prep
AI-guided enrichment automates tedious tasks that took up to 80% of data scientist's time before, redirecting focus to hypothesis testing.
Automated Compliance and Visibility
Encryption and de-identification are enforced on every record automatically, while real-time visibility replaces months of manual audit preparation for regulatory requirements.
Immediate Insights from AI Agents (LLMs)
Custom Research LLMs enable rapid querying and deep analysis of trial data to catch early toxicity markers and protocol deviations, not weeks later.
Efficient Cohort Scaling
Configuration-driven integrations minimize manual coding and QA, so you can expand site cohorts and trial arms without proportionally growing your engineering team.
How the technology works…
Agent Studio
Direct data access and vector store RAG with advanced reasoning agentic LLMs.
(like Cursor but for life science and data)
Streaming Pipeline & Functions
Real-time normalization & AI enrichment
Schema, Metadata, & Governance
Auto-drafted, versioned schemas + governance & compliance audit
Connector & Integration Layer
Lightweight on-site or on-demand agents
InSplice AI is an ai-native, real-time data-fabric & AI platform that ingests, governs and enriches live trial feeds, then snapshots and couples advanced reasoning LLMs with your data to immediately find insights. It's a lightweight "data patch" so you can leverage existing investments without vendor lock-in.

Connector & Integration

Bridging Your Critical Research Systems 65% real-world coverage on day one. InSplice will target 4 key connectors for its MVP to streamline common clinical, lab, and genomics data flows from launch - with plenty more connectors on the roadmap. Medidata Rave The #1 EDC platform used in over 50% of U.S. drug trials, ensuring your clinical data is instantly unified and inspection-ready. Key benefit: Accelerate site setup, amendments, and analyses without custom coding or manual exports. Thermo Fisher SampleManager The most widely adopted LIMS in life sciences, streamlining lab results and sample tracking data for downstream workflows. Key benefit: Clean, traceable, and governed lab data ready for regulatory review or AI training. AWS S3 Industry-standard storage powering petabyte-scale genomics and research pipelines across biotech and pharma. Key benefit: Stream large files directly into a unified data layer without custom glue code or compliance gaps. Oracle Clinical One The main EDC alternative to Rave, prevalent in top pharma and cross-border clinical trials. Key benefit: Never say "no" to a new sponsor or CRO due to incompatible systems, signaling enterprise readiness.

Schema, Metadata, & Governance

Building the Foundation for Trusted Data InSplice's Schema & Metadata Management provides a single source of truth for data definitions. This enables robust validation, evolution, and auditability through centralized schema registry and AI-powered automation. Central Schema Registry Supporting multiple dialects (JSON Schema, XML XSD, Avro, Protobuf), our registry normalizes definitions into a unified model while preserving original specifications. Each schema receives unique identifiers with semantic versioning and compatibility rules to prevent breaking changes. Ingest & Normalize Workflow Our system will automatically detect schema dialects, converts non-JSON schemas into internal JSON-schema format, and pre-generates validators to eliminate per-message parsing overhead. Schema Relationships & Lineage We will index and traverse references to build complete dependency maps of complex schemas, enabling impact analysis to determine which pipelines or models would be affected by schema changes. Governance Hooks Custom annotations for fields (PII, PHI, Calculated) drive tokenization and access-control policies, while embedded consent-status and retention-period metadata ensure compliance with regulations. AI-Enabled Schema Detection & Enrichment Our Functions Layer will leverage machine-learning techniques to automate schema discovery, classification, and quality control—transforming raw data samples into fully annotated metadata definitions. Automated Field Inference ML models analyze value patterns and context to propose field names, data types, and mappings to industry vocabularies like LOINC and SNOMED. Sensitivity Detection Functions automatically scan for HIPAA/HITRUST-sensitive elements and flag them with appropriate PHI tags to drive downstream security and compliance controls. Continuous Learning User corrections feed back into the model pipeline, improving future inference accuracy through a feedback loop of refinements. Pipeline Integration Enriched schemas propagate instantly to downstream validation stages, ensuring events are tagged, checked, and routed correctly.

Streaming Data to Functions

Core Vision The planned InSplice Functions System will enable researchers and data engineers to process live data from any source—without proprietary storage lock-in. This MVP roadmap outlines our technical approach. How Functions Will Work Each InSplice "function" operates as a stateless code block running in containerized environments. These functions execute when triggered by streaming data events. Functions will support Python, TypeScript/Node, and Go. They'll process event payloads, perform transformations, and emit outputs based on user-defined logic. User-Controlled Data Flow Users maintain full control of data storage destinations. Our "bring your own datastore" approach prevents vendor lock-in while providing execution environments and event delivery. Scaling Architecture The system enforces configurable concurrency limits per function. Our trigger router operates as a stateless service—simple for early deployments but shardable as usage grows. Transparent Development This roadmap represents our MVP vision. We're seeking design partners to provide input as we build InSplice, ensuring it meets real-world research and data engineering needs.

Agent Studio

Architecture & Technical Foundations Core Architecture Agent Studio will function as a modular orchestration platform connecting to life science databases through standardized, policy-controlled connectors. Key components include: Secure database connectors supporting relational, NoSQL, file repositories, and specialized clinical/genomic systems Centralized credential management ensuring data remains under customer control Automated data profiling that infers structure, content types, and relationships Parallel distributed processing infrastructure for handling high volume data Optional vector embedding for unstructured text to enable semantic query Advanced Reasoning System The platform's differentiating feature will be its multi-agent orchestration layer that transforms database connections into a dynamic research environment: Query decomposition into retrieval and reasoning steps Self-prompting and multi-agent reasoning patterns that simulate expert collaboration Hypothesis generation and verification against original data sources Transparent, citation-supported answers with explicit sourcing Error handling, ambiguity flagging, and edge case identification No LLM Retraining Required Unlike systems that need custom model training for each data source, Agent Studio will use dynamic retrieval and reasoning to adapt to any database structure or content type without model retraining. Enterprise-Grade Security All data processing will occur within customer-controlled environments, with credentials and sensitive information never leaving organizational boundaries. Compliance with HIPAA, GDPR, and other regulations will be built-in. Reasoning Similar to Human Experts By implementing collaborative multi-agent architecture, we aim to achieve research-grade analysis that mirrors how expert teams approach complex scientific questions with rigor and methodical validation. Agent Studio represents our technical vision for transforming life science data access and analysis. By focusing on secure connections to existing databases and employing sophisticated reasoning rather than simplistic RAG patterns, we're building a platform that will make specialized life science knowledge as accessible as web search, while maintaining the rigor required for scientific and clinical applications.

We are addressing critical R&D challenges you face.
Unify Disparate Trial Data
Researchers juggle CRFs, lab assay exports, genomic files and literature feeds across 5–7+ systems, creating analysis bottlenecks without a single source of truth.
Reduce Data-Prep Drag
Data scientists spend 60–80% of their time on cleaning, stitching and pipeline rebuilds—leaving just ~20% for actual modeling and insights.
Enable Domain-Specific Research LLMs
InSplice lays the groundwork for researchers to query an informed LLM capable of deep research analysis on your data quickly, turning clean, governed data into actionable intelligence.
Maintain Continuous Compliance
InSplice enforces encryption, de-identification, and FHIR/HL7 policies at ingest, yielding real-time audit logs instead of months of preparation.
Because, legacy approaches fall short against the challenge.
Batch ETL & Centralized Data Lakes
Nightly/hourly bulk exports create data latency, compliance burden, and require custom scripts for each schema change, triggering 2-4 week development cycles.
Clinical Data Suites (EDC-First)
Form-centric delays create trial "blind spots," while batch exports still require days of cleaning before AI use, with fragmented audit trails risking compliance gaps.
Homegrown, In-House Pipelines
Building custom frameworks takes 6-12 months, creates brittle code requiring constant maintenance, and offers no seamless path to utilize agentic LLMs.
Isolated RWD & Retrospective Analytics
Federated networks lack live trial feeds and integrated enrichment capabilities, leaving 85% of AI pilots stalled at scale-up.
Here's an example of how you might use InSplice.
Let's take a hypothetical use case. Meet Dr. Anita Patel, Senior Bioinformatician.
Dr. Patel has been tasked with building a safety-monitoring model and a companion Research LLM for a multi-site oncology trial. Today she needs to onboard three new clinical sites, validate their incoming data, enrich it for downstream modeling, and spin up AI agent(s) that her colleagues can query for early toxicity alerts.
Configure Site Connectors
Dr. Patel needs live access to each site’s trial data—electronic CRF exports, lab-assay results from the LIMS, and raw genomics buckets—without writing custom ingestion scripts. To accomplish this, she deploys pre-built connectors for eCRF, LIMS, and genomics data with just a few clicks in the Integration Dashboard.
Draft & Lock Schemas
Dr. Patel needs to understand the shape and meaning of incoming fields—patient IDs, assay values, gene variants—and apply her lab’s governance rules to each. The system auto-infers schemas from incoming data. Dr. Patel applies tags, units, and PHI policies before locking version 1.0.
Real-Time Streaming & AI Enrichment
Dr. Patel wants a clean, normalized dataset so her model training data is trustworthy from day one without clumsy UIs to manually configured transformations or a lot of service based infrastructure and coding. Live data streams through containerized microservices that AI helps her quickly write and deploy to normalize units, merge duplicates, enriching data gaps, and even generate synthetic examples to bolster statistical power if needed.
Continuous Compliance
Dr. Patel must ensure that every record meets regulatory requirements—no manual batch reports or spreadsheet audits. The Governance Module enforces consent flags and de-identification at ingest, with full audit trails for regulatory submission.
Train & Activate Research Agent
With days of clean, governed data now in the fabric, she needs to produce an LLM (AI agent that can think through her data) that her clinical team can query for protocol insights and safety signals. With just a few clicks, Dr. Patel launches the Agent Studio, selects her data sources, and provides instructions for an agentic AI model to familiarize itself and directly reference the data for iterative thinking and deep learning style analysis - a real research assistant.
Dr. Patel now has live data integration from 3 new sites, a locked and governed schema, a continuously enriched dataset, and a custom Research LLM answering safety and biomarker questions—transforming weeks of manual effort into immediate, actionable insights that help keep patients safe and accelerate the path to a cure.
Why choose InSplice
Live, Compliant Data Fabric
Pre-built connectors stream CRFs, LIMS exports and genomic buckets with edge tokenization and encryption that satisfy 21 CFR Part 11, HIPAA and GDPR continuously.
AI-Guided Enrichment & Governance
Containerized functions heal missing values, normalize units, and merge duplicates while governance rules enforce PHI de-identification and lineage automatically.
Configuration-Driven Integration
Automated schema discovery and tagging replace manual field-mapping, transforming a typical 2-4+ week custom build into a rapid configuration sprint.
Research LLM Studio
Aggregates versioned data and secure snapshots into a managed vector stores and queryable DBs that fine-tuned LLMs can directly reference.
How InSplice compares…
Key Competitors in Clinical Data Platforms
Saama
Strengths: Decade of life science AI experience with 90+ pre-trained models spanning 300M+ data points, providing deep domain expertise.
Weaknesses: Monolithic platform architecture requires extensive customization and integration efforts, limiting flexibility for evolving data and research needs.
InSplice Advantage: More AI-native and flexible architecture as a lightweight "data patch" that seamlessly integrates with existing systems, rather than a monolithic platform requiring extensive customization.
ConcertAI
Strengths: Specialized focus on oncology with a multi-agent AI framework and NVIDIA partnership for GPU-accelerated processing.
Weaknesses: Narrow therapeutic focus and reliance on external data sources may limit applicability across diverse research areas.
InSplice Advantage: Horizontally flexible across all therapeutic areas, with a custom AI pipeline that can be easily configured to your specific data and research needs.
TetraScience
Strengths: GxP-compliant platform for managing lab data with deep domain knowledge in that space.
Weaknesses: Specialized focus on lab data only, lacking the ability to integrate broader clinical trial data streams.
InSplice Advantage: Extends beyond just lab data to include a wide range of clinical trial data streams, with AI-assisted schema inference to seamlessly integrate diverse data sources.
Ganymede Bio
Strengths: "GxP-native" lab data platform with a "Lab-as-Code" approach for increased flexibility.
Weaknesses: Requires significant manual coding and configuration, limiting the ability to scale and adapt to changing data and research needs.
InSplice Advantage: AI automation reduces the need for manual coding, and our synthetic data generation capabilities can help fill data gaps.
While competitors excel in specialized areas, InSplice uniquely combines AI-driven data orchestration with advanced LLM capabilities in a lightweight, system-agnostic platform that continuously enriches your data to accelerate research insights and decision-making.
Help us launch the future of clinical research.
You can help us co-design and accelerate by investing now as an early adopter. In return, receive your first year free and 25% off year two once we launch.
Sign up to be notified when InSplice is ready and secure a discounted first year.
InSplice AI transforms siloed trial data into an AI-powered research engine, guaranteeing continuous compliance, and delivering targeted LLMs that surface life-saving insights in real time. Every moment counts—let's turn your trial data into cures, together.
If early adopters do not receive access to the MVP within 24 months of pre-paying, they will receive a full refund.
Early adopters can request a full refund at any time up until access.
InSplice AI is a United Effects Ventures portfolio company
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