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inClinico

Data-driven forecast of clinical trial probability of success for portfolio risk assessment and trial design optimization.

Solution by Insilico Medicine
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Overview

inClinico is a data-driven multimodal platform developed by Insilico Medicine for forecasting the probability of success (PoS) of individual clinical trials. By leveraging massive amounts of data spanning targets, diseases, clinical trial designs, and the scientists involved at both preclinical and clinical stages, inClinico enables rigorous clinical risk assessment and portfolio triage for life sciences stakeholders.

The platform is designed for buy-side analysts at pharma-focused investment funds, business development and licensing (BD&L) executives at pharmaceutical companies, and clinical researchers and developers seeking AI-augmented insights to improve trial outcomes and inform strategic decisions.

Core Features

  • Scoring of custom trials: Compare and optimize planned clinical trial designs to maximize their probability of success before execution.
  • Database of historical and ongoing clinical trials: Identify clinical catalysts that drive pharmaceutical growth, sort trials by PoS, and research the designs of successful studies.
  • Clinical Trial Outcome Scores: Analyze performance for individual trials using simple, data-driven PoS metrics.
  • Comprehensive Report Generation: Generate customized reports detailing PoS and the impact of individual features on predicted probabilities, drawing on inputs from OMICs data, drug structure, trial protocol, preclinical data, publications, grants, and patents.

Use Cases by Customer Profile

  • Buy-side analysts at pharma-focused funds: Search for investable assets, de-risk investment portfolios, and prioritize opportunities based on data-driven PoS scores.
  • BD&L executives at pharma companies: Conduct technical due diligence for mergers, acquisitions, licensing, and partnerships; perform competitive analysis; and de-risk pharmaceutical portfolios.
  • Clinical researchers and developers: Leverage AI-augmented trial design recommendations covering endpoints, sites, and eligibility criteria; conduct post-mortem analysis on failed projects for potential revival; and research general red flags in trial design.

Therapeutic Pipeline Due Diligence

  • Probabilities of success calculated across different data modalities with granular interpretation of predictions.
  • Industry-wide success rate analysis and individual clinical trial reports.
  • Summary reports with benchmarked pharmaceutical catalysts and clinical trials prioritized by PoS.
  • Reports include details on clinical trial sponsors and their financials.
  • Derived probabilities can be used to estimate net present value (NPV) more precisely, informing licensing and investment decisions.

Clinical Trial Design Enhancement

  • inClinico extracts meaningful representations from clinical trial protocols, including trial structure (blinding, randomization, cohorts), patient eligibility criteria, endpoints, and clinical site information.
  • Interactive reports detail the impact of individual protocol features on model predictions, including the exact quantified influence of each feature and feature groups.
  • Actionable insights guide changes to clinical protocols to improve PoS, with the ability to simulate alternative designs and generate detailed comparative reports.
  • Users can choose the best trial design aligned with both expert knowledge and data-driven recommendations.

Underlying AI and Data Infrastructure

  • Proprietary machine learning algorithms for information extraction and data harmonization.
  • Comprehensively harmonized and curated public data.
  • Advanced natural language processing (NLP) system with a feedback loop from industry experts.
  • Large preclinical data feed from contract research organizations (CROs).

Data Sources

  • 5 million OMICs data samples: Full spectrum of transcriptomics, genomics, epigenomics, proteomics, and single-cell data generated by the scientific community.
  • 30 million publications: Published biomedical research results.
  • 3 million grants: Life sciences research grant funding records.
  • 3.8 million patents: Patents covering the life sciences industry.
  • 342,000 clinical trials: Extensive knowledge base related to clinical trial design.
  • 13,000 drugs: Drug records spanning from Phase 1 clinical trials through to launched products.

inClinico has been prospectively validated through multiple case studies, including studies covering H2 2022–H2 2023 and earlier periods, and has been developed in collaboration with leading pharmaceutical partners including Pfizer, Boehringer Ingelheim, Astellas, Taisho, and Beijing Tide Pharmaceutical.

Meta

Domain
Computational Drug Safety & PKPD Modeling
Subdomain
Clinical Trial Simulation & Forecasting
Software type(s)
Analytical Platform
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
PharmaBiotechCRO
Development stage(s)
Preclinical / Pre-MarketClinical
Target user(s)
Research ScientistBioinformatician / Computational ScientistMedical Affairs ProfessionalCommercial / Market Access
Tag(s)
Uses AI