PharmaLex’s Global Statistics and Data Science team brings together a wide range of clinical biostatistics experts – from study design and planning to statistical analysis, reporting and data management. Our experts help companies with complex innovative trial design, translational and precision medicine, pharmacometrics, and data science across the clinical journey.
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Clinical Biostatistics - an integral part of successful clinical development
The drug development process involves a complex range of activities from clinical design to market access, all of which require in-depth knowledge and experience. Many companies struggle with the depth and level of expertise needed to manage complex trial designs and protocols, bring together and interpret different datasets and address regulatory expectations – particularly in more challenging fields such as rare diseases and pediatric studies.
PharmaLex’s Global Statistics and Data Science team is comprised of leaders in complex innovative trial design, translational and precision medicine, pharmacometrics, and data science supporting clients throughout the clinical journey. The team has experience in all aspects of study design and planning, as well as end-to-end biometrics services and clinical trial reporting.
We offer global solutions covering the entire product lifecycle
Our solutions, consisting of core services, which are tailored to address each of your unique requirements. Extensive program management expertise is a key success factor within our service solutions.
Innovative Clinical Trial Design
Over the past five years, the use of Bayesian and other nontraditional approaches to complex innovative design (CID) has become quite common in the design and analysis of clinical trials. In the United States, this growth has been fostered by the 21st Century Cures Act and PDUFA VI, which encourage the use of novel statistical methods for combining disparate data sources. This increased interest has been especially acute in medical devices and in rare and pediatric drug approvals but is now also spreading to all areas of regulatory science. Incorporating information from both randomized (e.g., historical trial data) and nonrandomized (e.g., disease registry and other real-world evidence) sources offers the potential to dramatically reduce the cost, timeliness, and ethical hazard of clinical trials.
Expertise for complex challenges
- Bayesian adaptive design
- Early phase dose-finding design
- Seamless clinical trials
- Biomarker-driven enrichment trials
- Master protocols with basket, umbrella, or platform design
- Use of real-world data in study design
- Synthetic control arms
- Interactions with different regulatory bodies
- Rare disease and pediatric studies
Clinical Biostatistics and Bayesian Statistics
Biostatistics is the application of statistical thinking and techniques to problems in biology and health. In biopharmaceutical work, tools like survival analysis, longitudinal data analysis, and generalized linear and nonlinear modeling have long been considered core tools. Such investigations can be for the purposes of discovery (as when we are looking for potential associations that merit further investigation), or confirmation (as when we evaluate the results of a clinical trial in a regulated setting). Besides traditional biostatistics methods, our team is well known in the industry for its Bayesian expertise in a broad variety of areas.
Bayesian expertise from discovery to post market
- Discovery, preclinical and developmental statistics
- Chemistry, Manufacturing and Control (CMC)
- Pharmacokinetic/Pharmacodynamic analysis
- Adaptive Clinical Trial Design (basket trials, umbrella trials, etc)
- Adaptive incorporation of auxiliary information (historical data, registry data, published information, real world data, expert opinion)
- Biomarker statistics
- Meta-analysis and network meta-analysis
- Post-market studies
Advanced Clinical Biometric Solutions
The GSDS team at PharmaLex delivers end-to-end biometric services to support the clinical development of medical products.
With experience across study design, data collection, analysis, interpretation and reporting, our global team can adapt to your project needs. While our experts can support projects globally, a local project lead ensures full and ongoing oversight, as well as quick and relevant responses to the local health authorities. By working in close partnership with our clients, our team ensures accurate and timely execution within budget.
Our biometric team is supported by a network of experts across the organization in regulatory affairs, pharmacovigilance, market access, Advanced Therapy Medicinal Products (ATMP) and more.
Study design and planning
- Data and statistical strategies in clinical programs
- Statistical input for protocol development
- Complex innovative trial design including Bayesian statistics
- Statistical analysis plans
- Sample size determination
- Randomization plans
- Modeling and simulation
- Biomarker-driven clinical trial design and experimental design within trials
- Regulatory advice
Analysis and reporting of clinical trials
- SDTM mappings and ADaM derivations
- Tables, figures, and listings programming
- Interim and final statistical analysis
- Statistical analysis reports and inputs to CSR
- Data monitoring committee (DMC) and data safety monitoring Board (DSMB)
- xml and analysis data reviewer’s guide
Data mapping / Data migration services
- Conversion of legacy data to CDISC compliant datasets
- CDISC compliant datasets for ISE/ISS
- CRF development
- CDASH standard datasets
- EDC Database build and validation
- Data capture and processing including cleaning, validation, coding
- Data import and data export specification preparation
- Third party data integration
- Supporting interim analysis and data safety meetings
- Risk-based monitoring
Modeling the effect of the drug product on the body, including the inherent uncertainty, and predicting the effects of changes in dosages, administration, or frequency can have a profound effect on both the cost and duration of a development program. Our team supports:
- Non-compartmental pharmacokinetic (PK) analysis
- Population Pharmacokinetic/pharmacodynamic (PK/PD) modeling
- Joint model- and mechanism-based models: biomarker, pharmacology, disease progression
- Support of translational activities: interspecies, preclinical-clinical, pediatric extrapolation
- Bayesian pharmacometrics
- Design definition and optimization through extensive model-based clinical trial simulations
Translational and Precision Medicine
Biomarkers play a crucial role in the era of precision medicine. From mechanism-based early development (e.g., susceptibility or response biomarkers) to patient-centric late development (predictive and prognostic biomarkers), PharmaLex has over 20 years of experience in translational sciences. We work with every data type, including multi-omics profiling and digital biomarkers, support companion diagnostics development as well as exploratory biomarker analysis.
Clinical Data Science
We make the most out of your data! Experienced across all phases and a broad range of therapeutic areas, we utilize our expertise in applied machine learning and artificial intelligence to provide insights in your data to help you make the right business decisions. Data visualization tools let you take a closer look and help guide you through your clinical study.
In CMC statistics, GSDS has been leading the field and acted as opinion leader for the last 15 years, proposing robust and innovative statistical solutions for the development, validation, and control of processes to manufacture all types of drugs. We help our customers applying the latest guidance on processes, formulation, and assay lifecycle (e.g. FDA process validation, ICH Q1-Q14), from early development and characterization, process performance qualification (PPQ), and assay lifecycle (validation, transfer and routine manufacturing use). We have state-of-the-art expertise in Quality by Design and Analytical Quality by Design. In manufacturing sciences, we also support annual review, acceptance criteria definition, release limits and specification computations, and stability studies.More Info
The discovery and pre-clinical development of new drug products is a growing challenge for biopharmaceutical industry. Rapid advances in technologies help to better understand the biology of a new drug product. The vast increase in data, however, increases the risk of false discoveries leading to costly mistakes. In PharmaLex our statistical experts use appropriate statistical methods to improve reproducibility and increase the efficiency of discovery and pre-clinical studies.More Info
Omics Data Science
Advances in omics technologies bring both opportunities and challenges in understanding disease and development of novel therapeutics. In PharmaLex, our experts have over twenty years of experience in understanding omics data – genomics, transcriptomics, proteomics, and metabolomics, among others – and uncovering insights to inform discovery and development of medicines.More Info
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