Biostatistics and programming
Comprehensive biostatistical solutions to accelerate drug development
Accurate data analysis and strategic trial design are critical for generating reliable results, meeting regulatory expectations, and bringing life-changing treatments to market efficiently.
ICON’s expert statisticians and programmers apply cutting-edge methodologies to enhance study design, data integrity, and regulatory compliance, while reducing risk and accelerating decision-making.
With a global team of 650+ specialists, we provide tailored support across all phases of clinical development. From early development through regulatory submission and post-market analysis, we deliver strategic insights that enhance trial efficiency and success.
By integrating AI and automation, we eliminate delays, streamline workflows, and free up valuable resources. We transform complex data into clear, actionable insights, empowering you to make informed decisions with confidence.
Our services
Strategic and regulatory statistical consulting
Get comprehensive, collaborative support on all aspects of your data strategy from trial design to post-submission safety reporting. Our statistical data strategies are designed to anticipate and address health authority requirements. With decades of experience, our team are adept at capturing and communicating product label and benefits claims.
Early development data and scientific services
Ensure your study gets off to the best start with the most relevant data to inform your decisions. We provide statistical services and programming for phase 1 studies, including the preparation of Statistical Analysis Plans (SAP), SDTM, and eSubmission documents, as well as the production of tables, figures, and listings. If your study is conducted at an ICON Phase 1 clinic, our dedicated statistics and programming team specialises exclusively in supporting studies within these clinics.
Operational delivery
As your study progresses and becomes more complex, you may require additional operational support. We offer biostatistics and statistical programming services for Phase 1–4 patient studies across multiple locations. Our services include SAP preparation, SDTM and eSubmission development, BLA submissions, identification of data sources, analysis requirements, and data mapping/standardisation evaluations.
Clinical pharmacology
Understanding and communicating your compound’s pharmacokinetics (PK) demands access to a range of metrics. Access expert support calculating PK parameters and planning, preparing and including PK inputs for SAPs, final study reports, clinical development plans, protocols and submissions.
Data monitoring committees
Regulators increasingly emphasise safety surveillance and proactive reviews of clinical trial data. Get support recruiting, vetting and managing your trial’s DMC and strategic sponsor advice on when to change, stop or adapt a trial due to safety concerns, efficacy or utility of the trial. Ensure scientific integrity with flexible options tailored to your trial scope.
Commercialisation and outcomes
Monitor and address your product’s long-term safety and effectiveness in a non-controlled environment. Help patients to understand their prescribed product including survival rate, factors contributing to positive outcomes and comparisons between different products.
Integrated Summaries of Safety (ISS) and Efficacy (ISE)
Our services include integrating clinical trial data into stand-alone SDTM or ISS/ISE ADaM, conducting integrated safety and efficacy analyses, preparing regulatory-compliant submissions, and supporting pre- and post-submission interactions with regulatory agencies to facilitate drug approval. Additionally, we can assist with individual studies within a submission, including legacy data conversion to CDISC standards and ensuring compliance with regulatory guidelines.
Scalable and fully customisable models
ICON is a trusted, market-leading partner to pharmaceutical, biotech and medical device organisations of all sizes. We are dedicated to helping sponsors implement, manage, and optimise high-performing functional teams.
Our leadership approach provides bespoke oversight of Biostatistics & Programming activities, ensuring our clients’ projects run seamlessly. By driving team performance and guaranteeing consistent, successful delivery, we empower sponsors to achieve their trial goals with confidence and precision.
We offer a wide range of customisable operating models to meet your needs, whether using ICON systems, sponsor systems, or a hybrid approach. Services can be delivered as consulting, standalone, FSP, blended or full service and across all therapeutic areas.
Our experience
We have more than 650 statisticians and programmers spanning the US, Latin America, EU, South Africa and Asia Pacific. No matter where your trials are located you can tap into expert support in the same timezone. The majority (60%+) of our people have advanced degrees (Masters, PhD) and an average of 19 years industry experience. All our programmers are trained to deliver CDISC SDTM and ADaM compliant data structures.
ICON is a proud corporate sponsor of CDISC, advancing global data standardization since 2000. Angela McPartlane, Vice President of Biostatistics & Programming, serves on the Board of Directors for Statisticians in the Pharmaceutical Industry (PSI), driving collaboration and promoting best practices in biostatistics.
Partner with ICON for biostatistics and programming expertise for innovative clinical trial designs. Contact us for more detail on how we can support your trial.
Exploring FDA guidance for modern Data Monitoring Committees
In this whitepaper, we explore the new FDA draft guidance on Data Monitoring Committees, highlighting key updates and their impact on DMC operations and clinical trials.