Excellence in Clinical Trial Biostatistics

Clinical Success with Expert Biostatistics

Navitas Life Sciences excels in delivering high-quality Biostatistics services, ensuring robust data analysis and seamless execution of clinical trials. Our skilled team, proficient in Clinical Statistics and SAS Programming, is committed to supporting pharmaceutical and biotech clients in achieving their clinical submission milestones. With expertise in Data Standardization and CDISC compliance, we provide precise, reproducible data essential for global regulatory submissions, including those to the USFDA and EMA.

Statistical Rigor Meets Clinical Precision

As a leading Biostatistics CRO, we offer comprehensive support throughout the drug development process. Our biostatisticians bring deep scientific knowledge and experience to trial design and statistical methodologies, ensuring accurate, timely, and regulatory-compliant data submissions. By leveraging advanced technologies and meticulous attention to detail, Navitas Life Sciences empowers clients to navigate the complexities of Biostatistics in clinical trials, driving successful outcomes.

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Our High-quality Biostatistics and Statistical Programming Services Include:

  • Protocol for hybrid design, Bayesian and Adaptive methodologies
  • Sample size estimation and justification
  • Randomization and blinding
  • Creation of safety and efficacy related TLGs and CDISC datasets
  • Multiple submissions: IA, CSR, DMC, IB, PSUR, DSUR, RMP, ISS/ISE, Pooling

Biostatistics Support Across the Drug Development Spectrum

With an average of 15 years of experience, our biostatistics team provides efficient and cost-effective outsourcing solutions for Biostatistics, Programming, and CDISC compliance.

Early Phase Clinical Studies

Early-phase clinical studies statistical activities include Study Design and Planning, power analysis and precision-based methods to determine sample, Randomization Techniques, Pharmacokinetics (PK) and Pharmacodynamics (PD) Analysis, Early Efficacy Assessment, Safety and Tolerability Analysis, Simulation Studies and Regulatory Reporting and Compliance.

Late Phase Clinical Trails

We provide advanced study design and planning , comprehensive data analysis including missing data handling, sensitivity and exploratory analysis, DSMB/DMC support for statistical monitoring, regulatory compliance and reporting, including data standardization and Integrated Summary of Safety and Efficacy (ISS/ISE) submission and Meta-Analysis and Evidence Synthesis

Post-Marketing Surveillance, RWE & HEOR studies

These studies provide ongoing assessment of safety, effectiveness, and economic value in real-world settings. Our statistical services ensure that these studies are designed, executed, and analysed with the highest level of scientific rigor.

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Biostatistics & Statistical Programming

Navitas Life Sciences provides a wide range of services to create derived-analysis datasets and Tables,Listings & Figures (TLF) as specified in your protocol or Statistical Analysis Plan.

CASE STUDY

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Partnering to accelerate success in Clinical Submissions

Find out how we supported a Top 5 Pharmaceutical company specializing in Oncology, enhance client productivity and accelerate deliverables by developing advanced macros and optimizing in-house tools, leading to multiple contract extensions.

ARTICLE

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4 Strategies for Data Managers to Modernize and Transform Clinical Data Science

Published in: Applied Clinical Trials
Explore why it is important to track the changing requirements of data managers, anticipating future trends, to understand the factors that could spearhead innovation and efficiency.
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Highlights of Biostatistics Support

Shaping Study Decisions & Uncovering Insights with the innovative design and Bayesian statistical approach

  • Comprehensive Strategy for faster drug development strategy and decision-making
  • Proficiency Across Various data collection methods for various Therapeutic Fields
  • Up to date with latest statistical methodology and Bayesian statistics
  • Adaptability and efficiency to comply with CDISC format and define packages
  • Worldwide Presence with various Regulatory Exposure

Gain the Navitas Life Sciences Edge

Holistic Approach

Holistic Approach

Balancing scientific rigor with cost-effectiveness.
8 Offices World Wide

8 Offices World Wide

Including 4 delivery centers across the globe.

Specialized Focus

Specialized Focus

Expertise in vulnerable populations and niche areas.
Strategic Support

Strategic Support

From TPP to regulatory compliance, we cover all bases.
Expert Team

Expert Team

Medical monitors with rich academic and industry experience.

BLOGS

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Navitas Life Sciences' Cutting-Edge Clinical Data Science for Efficient Clinical Trials

Navitas Life Sciences utilizes expert-driven Statistical Programming, Biostatistics, and Data Management services support for pharma clinical data sciences leading to successful clinical trial outcomes.
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R Programming and the Future of Clinical Data Services with Navitas Life Sciences

At Navitas Life Sciences, we are committed to leveraging cutting-edge technologies and methodologies to drive innovation in clinical trials.
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Navitas Life Sciences’ Clinical Data Services

Navitas Life Sciences boasts extensive experience in Clinical Data Services, including Data Management, Biostatistics & Programming, Data Standardization, Medical Writing, and Submissions.

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