Innovative Global CRO

Delivering Excellence Across the Clinical Landscape

Technology

Cutting-edge AI-based solutions optimize workflows, resource allocation and add another quality layer

Transformation

Automation and AI deliver faster, high-quality outcomes while enabling innovative breakthroughs

Trust

Transparent processes, strict compliance with industry standards and double programming ensure data integrity

Who are we

Efficiency Beyond Expectations
The Art of Quality: Where Innovation Meets Excellence

Transforming clinical research through innovation and precision

Proven expertise in biometrics and high-complexity data engineering projects

Distributed teams across
US, Austria, Croatia, Montenegro, Poland, India, Israel and Ukraine

We don’t just execute projects: we redefine the boundaries of what’s possible in clinical research. Our unique approach harmonizes the power of AI with a human touch, ensuring compliance, transparency, and excellence while maintaining cost efficiency

Trusted by Industry leaders

Jason Martin

Vice President Digital Technologies, NAMSA

I’ve had the privilege of working with the team that now forms the core of Trialt for over 10 years across various companies. They have been instrumental in supporting critical projects, including developing state-of-the-art tools like metadata repositories, advanced visualization platforms, and IT infrastructure solutions. Their technical expertise and innovative mindset have consistently impressed me.

I wish the team at Trialt every success in this new venture and am confident they will continue to deliver outstanding results in the industry!

Case Studies

Scaling Statistical Programming team for large CRO

Objective and Challenge
A large CRO required rapid scaling of its biometrics services, requiring fully operating support of 12 senior statistical programmers within three months. The key challenges included meeting a tight timeline, ensuring seamless integration, and maintaining compliance with industry standards, all without disrupting ongoing operations.

Approach
We leveraged our experience training over 100 programmers in four years to design a tailored, fast-track onboarding plan. This included a detailed skills gap analysis, phased onboarding, and custom training focused on the CRO’s specific workflows and compliance needs. Recruitment leveraged our extensive networking, emphasized experienced candidates, while a buddy system, standardized templates, and intensive orientation accelerated integration. Regular progress reviews and feedback loops ensured continuous improvement.

Results

The team was fully operational within three months, achieving productivity in 6–8 weeks—well ahead of industry benchmarks. CRO was more than satisfied with the team's quality of deliverables and professionalism, reflecting a seamless scaling effort.

Rescue study

Objective and Challenge
A small-sized CRO was left in a critical situation when their initial vendor failed to deliver the required 72 TLFs (Tables, Listings, and Figures) and compliant datasets (SDTM and ADaM) on schedule, leaving only three weeks for us to complete the project. The study involved a complex efficacy component that required precision and flawless quality, with strict adherence to regulatory standards. Additionally, frequent data discrepancies demanded near real-time resolution, adding significant complexity and urgency to an already challenging timeline..

Approach
To meet the tight deadline, we assembled a team of highly experienced statistical programmers and biostatisticians, supported by a robust automation framework. Automated workflows and pre-validated templates allowed us to streamline dataset generation, programming, and quality assurance processes. The team worked in parallel across tasks, ensuring maximum efficiency while maintaining 24/7 availability to address unexpected challenges. A near real-time issue resolution system and daily progress updates ensured full transparency with the CRO, enabling quick alignment and minimizing delays.

Results

All deliverables were completed within the three-week timeline, with the first submission passing quality control checks flawlessly. The team’s efficient use of automation reduced manual effort by 40%, allowing focus on the complex efficacy components and ensuring impeccable results. The CRO praised the team’s professionalism and ability to rescue the project, securing their sponsor’s confidence and restoring the study's trajectory. This effort demonstrated how expertise and automation can deliver success in the most demanding scenarios.

Generative AI product for market access support

Objective and Challenge
Market access professionals face the daunting task of navigating vast amounts of payer documentation and policy updates to ensure compliance and alignment with regulatory changes. Traditional methods are time-intensive, prone to errors, and lack efficiency, especially when handling large datasets. The need for a solution to automate document processing, trace policy evolution, and provide actionable insights was clear, particularly for organizations managing high volumes of medical policies and classifications.

Approach

We developed Market4Health.com, a cutting-edge generative AI-powered platform tailored for market access support. The product integrates multiple features to address key pain points:

Up-to-date Policy Inventory: Automated cataloging ensures integrity, completeness, and real-time updates across payer documentation.
Historical Prospect of Regulations: The platform preserves and tracks policy changes, allowing users to trace the evolution of regulations and pinpoint critical updates.
AI-Powered Engine: Advanced search capabilities operate with numerous document attributes, enabling professionals to efficiently locate relevant information.
Shareable and Reliable Outputs: Tools for query history, favorites, and report generation in standard formats streamline collaboration and decision-making.
The platform also features generative AI tools for automatic ICD and classification code annotation across 50,000+ documents, automatic summarization, and RAG (Retrieval-Augmented Generation) for seamless human-language interaction with the corpus.

Results

Market4Health.com revolutionized how market access teams handle policy documentation, reducing manual effort by over 60% and accelerating data retrieval by nearly 70%. The AI-powered annotation and summarization tools streamlined complex document analysis, significantly enhancing productivity and decision-making speed. Organizations using the platform reported improved compliance, better policy insights, and more effective collaboration through high-quality, shareable outputs. This product highlights the transformative potential of generative AI in market access, delivering unparalleled efficiency and accuracy in document management.

Custom data analysis platforms development for large CRO

Objective and Challenge
A large CRO engaged us to take over the development of two highly complex systems: a Metadata Repository for data management automation and a Statistical Computing Environment for statistical programming. The project was fraught with challenges, including a rare and outdated technology stack, an absence of proper documentation, and legacy issues that had severely impacted performance. The existing team’s inefficiencies and unresolved issues had created significant delays in study builds and operational workflows, demanding immediate intervention and a long-term solution.

Approach

We inherited the project and rapidly scaled the team to 15 skilled professionals with expertise in data management systems and statistical computing. The team focused on:

Resolving Legacy Issues: Conducted a deep audit of the systems to identify and fix critical performance bottlenecks and legacy bugs.
Enhancing Performance: Optimized the architecture and workflows, substantially improving system speed and reliability.
Implementing New Features: Delivered a suite of new functionalities to align with evolving client needs, including advanced automation for data management and robust enhancements for statistical programming.
Mitigating Risks: Established thorough documentation and knowledge-sharing practices to ensure long-term system maintainability.
Our team's ability to navigate the rare and complex technology stack enabled us to stabilize the systems while simultaneously driving innovation and performance improvements.

Results

Over four years, we provided flawless support and continuous improvements, significantly reducing the lead time for study builds. The client reported measurable performance enhancements and operational efficiencies, leading to faster project delivery and improved satisfaction for their sponsors. By resolving longstanding issues and implementing modern features, we transformed the platforms into reliable and high-performing assets. This success underscores our capability to manage and modernize even the most complex systems, ensuring sustainable value for our clients.

Developing a Custom ePRO Solution for an Oncology Study

Objective and Challenge

An oncology study required a custom electronic Patient-Reported Outcomes (ePRO) solution to collect data on patients' quality of life. The project had to address several critical challenges, including:

Developing secure and compliant on-device software that would operate seamlessly on Windows tablets, selected for their reliability and cost-effectiveness.
Managing the selection, setup, and logistics of distributing Windows tablets across study sites.
Ensuring integration with the Electronic Data Capture (EDC) system for real-time and error-free data synchronization.
Providing ongoing data management support, including quality control and troubleshooting, to ensure the integrity of collected data.

Approach

Our team implemented a structured approach to deliver a comprehensive solution:

Software Development: Created an intuitive and compliant application for Windows tablets, designed specifically for oncology patients. The software focused on ease of use, robust security measures, and adherence to regulatory requirements, ensuring a patient-friendly experience and high data accuracy.
Device Selection and Logistics: Windows tablets were chosen for their secure ecosystem and compatibility with the custom software. The team managed the procurement, configuration, and distribution of tablets to study sites, ensuring seamless deployment and readiness.
Integration with EDC: Worked closely with the EDC vendor to build and test APIs for real-time data transfer, enabling seamless synchronization between the tablets and the central database.
Support Framework: Established comprehensive data management processes, including routine quality checks and rapid response protocols to address any technical issues during the study.

Results

The custom ePRO solution was successfully implemented, with Windows tablets proving to be a reliable platform for data collection. Patients found the application easy to use, leading to high compliance and complete data capture. Integration with the EDC system enabled real-time data monitoring and reduced manual data handling errors. The project’s success highlighted our ability to deliver innovative, secure, and compliant solutions tailored to the unique needs of oncology research, ensuring robust and high-quality patient-reported data.

Development and Performance Optimization of an ML Package for Optimal Subgroup Search

Objective and Challenge

A large CRO required the development and optimization of a machine learning (ML) package for optimal subgroup search, a critical tool for identifying patient subgroups with enhanced treatment responses. The project aimed to:

Extend the team’s capacity by adding expertise in R test code development for functionality implementation and testing.
Transition the package to a production-ready state by rewriting core components in C++ for improved performance.
Address significant performance bottlenecks, as the initial implementation struggled with speed and scalability, hindering practical applications.

Approach

We deployed a team of skilled developers with expertise in R, C++, and ML optimization:

Team Augmentation: Expanded the client’s team by onboarding experts to implement, test, and validate new functionalities in R, ensuring the robustness and reliability of the package.
Rewriting in C++: Transitioned the computationally intensive components of the package from R to C++, leveraging C++'s efficiency to drastically enhance performance. The integration maintained compatibility with the R interface to ensure seamless usability for the end users.
Optimization: Applied advanced performance tuning techniques, including algorithmic refinements and memory management improvements, to maximize efficiency.
Rigorous Testing: Developed comprehensive test cases and validation frameworks to ensure functionality, accuracy, and compliance with statistical and regulatory standards.

Results

The ML package was successfully transformed into a production-ready tool, with performance improved by 15 times, enabling the analysis of large datasets in a fraction of the original time. The seamless integration of the optimized C++ components with the R interface ensured user familiarity while delivering significant speed and scalability benefits. The CRO commended the team for their technical expertise and ability to deliver a high-performance, reliable solution that supported advanced subgroup analyses, enhancing their operational efficiency and decision-making capabilities.

Modes of Collaboration

Functional Service Provider

Scalable resources for data management, statistical programming, biostatistics, and medical writing, ensuring cost-efficiency and quality

Full-Service Model

End-to-end trial management for seamless execution, streamlined communication, and high-quality outcomes

Consulting services

Expert guidance on CDISC, data quality, trial design, regulatory strategy, and project management to optimize success

Regulatory Submission Support

Compliance-focused documentation and submission services for timely approvals

Core Services for Clinical Trials

Biostatistics

Our Biostatistics services include Trial Design & Analysis, Regulatory Compliance, Interim Analysis & Safety Monitoring, and Data Visualization

Randomization scheme creation
Sample size estimation
Statistical section of protocol development
Development of the statistical analysis plans (SAPs)
TLF Mock Shells creation
Interim Analysis
Blinded Biostatistical Services
Analysis review and statistical input

Statistical Programming

Our Statistical Programming services leverage in-house AI-driven tools and support various data analysis and reporting needs

Development and Validation of CDISC-compliant datasets
Generation and Validation of tables, listings, and figures (TLFs)
aCRF, Define.xml, SDRG and ADRG
ISS\ISE integration and analysis
Preparation of submission-ready package
Ad-hoc data analysis and reporting
Publications preparation & Support

Data

Management

Our Data Management services will help your business to collect, analyze and handle your research data efficiently and securely

eCRF Design and Database programming
Data validation and Edit Checks
Data entry personnel training
Data collection and capture
Data Cleaning & Reporting
External data reconciliation
Medical Coding

Medical

Writing

Developing Clinical Trial documentation that effectively and clearly describes research, product use, and medical information

Informed Consent Forms creation
Clinical Study Protocol development
Clinical Study reports
Regulatory Submission documents
Manuscript Writing and Publication support
Patient and Investigator Brochures

Comprehensive biostatistics and statistical programming support
Expertise in large-scale pharma and CRO projects
Industry leaders driving accuracy and innovation

Clinical Trials

Innovation and Engineering: Beyond the Basics

Data Integration & Analytics

Complex data integration, adjacent data analytics (financial, actuarial, and unstructured data), and advanced visualization platforms

Compliant real-time EDC/EHR Integrations
Complex data integration of EDC and other sources.
Adjacent data analytics and resporing for actionable insights.
Advanced reporting and visualizations solutions for clinical monitoring

Development

Solutions for biomarker discovery, subgroup efficacy analysis, and predictive modeling

Solutions for biomarker discovery and subgroup efficacy analysis.
Predictive modeling tailored to clinical and operational needs.
Advanced algorithms for precision medicine applications.

Software Engineering

Metadata repositories, automated computing environments, and generative AI for document automation and analysis

Development of metadata repositories and automated computing environments.
Scalable and compliant engineering solutions for streamlined workflows.
Compliant and validated mobile and web development for clinical solutions
Custom integrations for EDC, ePRO, and other clinical data systems.

GenAI

Adoption

AI-powered interaction with US payer policy databases for seamless policy navigation and decision-making

Automated annotation and classification of medical data.
Summarization of clinical and policy documents.
Real-time RAG for healthcare knowledge bases.
Context-aware translations for regulatory compliance.
AI-driven insights for personalized medicine.
Patient engagement via conversational AI.

Our advanced services integrate state-of-the-art technology and deep domain expertise to tackle the most complex challenges in clinical research. From AI-driven insights to seamless data engineering, we empower clients to make smarter, faster decisions with confidence

Beyond the basics

Workforce

Behind the Numbers
More Than Metrics:
A Testament to Our Impact

Skilled workforce

A diverse team with expertise spanning biostatistics, statistical programming, and data engineers, capable of handling projects of any complexity

Own training center

Ensures our teams remain at the cutting edge of industry advancements and best practices through continuous learning

Direct access to talent pools

Leveraging a vast network to attract and retain top-tier professionals across the globe

Passion for Development

A culture that thrives on innovation and professional growth, fostering excellence in every project

We're hiring!

1/18/25

Remote

Senior SAS Programmer

Details

1/18/25

Europe

Principal Biostatistician

Details

Request demo

Innovative Global CRO

Delivering Excellence Across the Clinical Landscape

Technology

Transformation

Trust

Efficiency Beyond Expectations The Art of Quality: Where Innovation Meets Excellence

Transforming clinical research through innovation and precision

Proven expertise in biometrics and high-complexity data engineering projects

Distributed teams across US, Austria, Croatia, Montenegro, Poland, India, Israel and Ukraine

We don’t just execute projects: we redefine the boundaries of what’s possible in clinical research. Our unique approach harmonizes the power of AI with a human touch, ensuring compliance, transparency, and excellence while maintaining cost efficiency

Trusted by Industry leaders

Case Studies

Scaling Statistical Programming team for large CRO

Modes of Collaboration

Core Services for Clinical Trials

Innovation and Engineering: Beyond the Basics

Behind the Numbers More Than Metrics: A Testament to Our Impact

We're hiring!

1/18/25

Remote

Senior SAS Programmer

1/18/25

Europe

Principal Biostatistician

Contact us

Efficiency Beyond Expectations
The Art of Quality: Where Innovation Meets Excellence

Distributed teams across
US, Austria, Croatia, Montenegro, Poland, India, Israel and Ukraine

Behind the Numbers
More Than Metrics:
A Testament to Our Impact