Our Solution: TriClick

 
 

TriClick:

An Integrated All-in-one AI Platform to Accelerate Clinical Trials

TriClick is an extensible agentic AI platform built to solve complex clinical data and documentation challenges. Thanks to its modular structure, it can be offered as an all-in-one solution to pharmaceutical clients. Notable highlights of the platform include:

Optimized workflows

Automating compliance and data analysis, making those tasks up to 20x faster

Unmatched accuracy

Achieving 98%+ precision through fine-tuned AI models and continuous learning

Built with data security in mind

Whether it’s proprietary company data or protected health information, modules are built to avoid unwanted data releases

 

AI Agents in TriClick:

triClick Compliance

Automatic desensitization of medical information to ensure compliance with regulations using advanced Natural Language Processing techniques.

Our Data Compliance Agent automatically scans documents, detects sensitive data, obscures it, and returns anonymized data that follows the regulations supplied (e.g. HIPAA). It also securely stores relationships, allowing de-anonymization if needed.

TriClick Evidence

Extracting clinical information from various sources to support regulatory filings and scientific decisions.

There are massive amounts of information available to inform clinical trials or identify new targets, and it is difficult to query it at scale. Using our Natural Language Processing solutions, we can transform large amounts of text data into searchable databases, and extract information relevant to your needs.



triClick Stats

Automatically generates TLF by integrating SAP, SDTM-compliant datasets, etc. This modular, step-by-step system enables automated interpretation of SAP logic and

streamlined output generation — ensuring consistency, traceability, and compliance throughout the reporting process.

 

Biostatistics and Biostatistical Programming  

Hill Research delivers end-to-end biostatistics and programming services, ensuring FDA/EMA-compliant quality, rigorous validation, and impactful submissions—trusted by leading global pharma to accelerate trials and regulatory success.

    • Development of clinical trial protocols, including study design, power and sample size determination, and creation of randomization schedules 

    • Preparation of the Statistical Analysis Plan (SAP) and development of TFL shells in accordance with the clinical study protocol 

    • aCRF annotation 

    • SDTM and ADaM dataset specifications, SDTM, ADaM data set generation, independent validation of SDTM and ADaM datasets, including Pinnacle 21 validation and report 

    • Creation of Define.xml, SDTM and ADaM Reviewers Guides 

    • Development of analysis datasets and TFLs to support Clinical Study Reports (CSRs), ad-hoc analyses, publication, signal detection, planning and designing of new studies. These include analyses of data from combined studies and individual studies, post-hoc analyses 

    • Independent validation of datasets and TFLs to ensure accuracy and compliance with statistical standards 

    • Conduct database quality reviews, perform data reconciliation, and consistency checks across sources 

    • Execute dry runs and prepare final deliverables of datasets and TFLs in FDA-compliant formats for New Drug Application (NDA) submissions 

    • New Drug Applications (NDA), Biologics License Applications (BLA), and Integrated Summaries of Safety and Efficacy (ISS/ISE). 

    • Clinical Data Interchange Standards Consortium (CDISC) deliverables, including Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM). 

    • Electronic Case Report Tabulation (eCRT) submission packages. 

    • Define.xml / Data Definition Tables (DDT). 

    • Investigator’s Brochures (IB). 

    • Investigational New Drug (IND) applications. 

    • Statistical defense of data and analysis results 

    • Statistical evaluation of data and analysis results of drug candidates 

    • Statistical analysis and programming support for Data Monitoring Committee (DMC) and Data and Safety Monitoring Board (DSMB) activities 

    • Conduct of unblinded data analyses to support interim assessments of ongoing clinical studies 

    • Data integration activities, including preparation of Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE). 

    • Conversion of legacy datasets into CDISC-compliant formats (SDTM and ADaM). 

    • Assembly and quality control of analysis datasets, statistical tables, listings, and figures (TLFs). 

    • Preparation and QC of study reports and submission-ready deliverables to support regulatory filings. 

    • BIMO (Bioresearch Monitoring Program) readiness support, ensuring traceability, data integrity, and compliance of submitted datasets and documentation for FDA inspections. 

    • Cross-functional teams of Medical Writers, Biostatisticians, and Medical/Regulatory Reviewers work together to produce abstracts, manuscripts, peer-reviewed publications, conference presentations, and posters. 

    • Development of abstracts, manuscripts, publications, presentations, and posters through collaboration between Medical Writers, Biostatisticians, and Medical/Regulatory Reviewers. 

FSP (FUNCTIONAL SERVICE PROVIDER)

Hill Research FSP model offers biotech and pharmaceutical companies fiexible, scalable access to specialized expertise across biostaistics, statisticalprogramming,and advanced technology enablement. By combining highly skilled professionals with Al-driven innovation and modem infrastructure, wedeliver measurable efficiency, quality, and compliance for clinical development programs.

    • Development and validation of SDTM/ADaM datasets, tables, listings, and figures (TLFs). 

    • Support for clinical study reports (CSR), interim analyses, ad-hoc requests, and regulatory submissions. 

    • CDISC-compliant deliverables and FDA/EMA submission readiness. 

    • Study design, sample size estimation, and statistical methodology support. 

    • Development of Statistical Analysis Plans (SAP), Mock Shell and randomization schedules. 

    • Statistical oversight of Data Monitoring Committee (DMC/DSMB) activities, interim analyses, and integrated summaries (ISS/ISE). 

    • Adaptive trial designs applied to oncology studies to enable flexible modifications during conduct 

    • Innovative designs for rare disease studies, including crossover and randomized delayed-start approaches 

    • Simulation of operating characteristics to evaluate and optimize study design strategies 

    • Trial event projection to support accurate study planning and execution timelines 

    • Power and decision boundary analyses conducted using R to guide interim and final decision-making 

    • Comparisons with virtually matched historical data to strengthen study outcomes and interpretability 

    • Expectation–maximization (EM) algorithms and Bayesian classification methods applied to blinded data for early insights into treatment effect 

    • Data mining, predictive modeling, and meta-analyses performed to inform trial outcomes and strategies 

    • Signal detection and monitoring implemented for continuous safety and efficacy assessment 

    • Exploratory analyses conducted to guide planning and design of future clinical studies 

    • Expert statistical programming support provided to deliver robust implementation of advanced methodologies for FDA interactions  

    • Implementation of AI-powered automation for dataset conversion, TLF generation, and QC processes. 

    • Predictive modeling and machine learning integration to optimize trial design, recruitment, and analysis efficiency. 

    • Development of custom tools to reduce manual workload and accelerate timelines. 

    • Design, deployment, and maintenance of secure, compliant, cloud-enabled SAS environments. 

    • Support for hybrid infrastructures integrating on-premise and cloud solutions. 

    • Ensuring 21 CFR Part 11, GxP, and GDPR compliance for validated systems.