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Where You Can Meet Navitas Life Sciences in 2025
Navitas Life Sciences provides a powerful combination of expertise and experience to advance global health. Headquartered in Gaithersburg, US, we offer a wide breadth of services, from clinical trials management, clinical trial data management services, to expert regulatory services, and pharmacovigilance (PV) consultancy. With more than 35 years of experience, we work closely with pharmaceutical, biotech, medical device companies, non-profits, and U.S. federal agencies to move therapies from concept to market faster.
As one of the leading clinical trial data management companies, we deliver high-quality, compliant, and timely data to support every phase of development. Our advanced platforms like OneClinical® and safetyREADY® are designed to streamline operations, offering near real-time analytics and enhancing trial outcomes. Whether you're looking for robust pharmaceutical regulatory consulting services, specialized medical device regulatory consulting services, or trusted FDA regulatory consulting services, we’ve got you covered. Our experienced teams also provide detailed regulatory writing services, ensuring submissions are clear, accurate, and ready for global approvals.
Safety is at the heart of what we do. Our comprehensive PV and safety offerings span from pre-approval to post-marketing, backed by cutting-edge PV solutions and global operational support. With recognized leadership from our 10 industry-leading networks including: pvnet®, pvconnect®, labelnet®, and medtechnet™, and recognition by industry analysts like IDC and Everest Group, Navitas Life Sciences continues to deliver what matters most, faster access to safe, effective therapies.
Comprehensive Clinical Trial Management Solutions
Advancing Research with Effective Clinical Trial Management
Navitas Life Sciences specializes in clinical trials management, providing strategic planning, oversight, and flawless execution of research studies that test the safety, efficacy, and real-world impact of new medical treatments. Our robust platform ensures end-to-end clinical trial delivery, from protocol design to final regulatory submissions.
With increasing complexity in trial designs and global operations, our integrated clinical trial project management plan ensures milestones are met with speed, precision, and compliance.
Why Effective Trial Management Matters
Efficient clinical trials management is critical to achieving trial success. Navitas delivers excellence across all key pillars:
- Regulatory Compliance: Adhering to global standards, safeguarding ethics and quality.
- Data Integrity: Maintaining high-quality, audit-ready trial data that informs critical decisions.
- Cost and Time Efficiency: Optimizing timelines and budget across geographies.
- Patient Safety: Implementing robust monitoring and ethical protocols to protect participants.
The 4 Phases of Clinical Trials
| Phase | Purpose | Participants |
|---|---|---|
| Phase I | Assess safety, dosage, and side effects | Small group (20–100) |
| Phase II | Evaluate efficacy, identify optimal dosage | 100–300 patients |
| Phase III | Confirm effectiveness, monitor rare events | Up to 3,000 patients |
| Phase IV | Post-marketing surveillance | General population |
Our End-to-End Clinical Trial Management Services
Navitas Life Sciences is a trusted partner for pharmaceutical, biotech, nutraceutical, and medical device companies worldwide. As one of the leading clinical trial data management companies, we ensure seamless coordination from start to finish.
Core Offerings:
- Study Design & Protocol Development
- Site Selection and Feasibility
- Project & Risk Management
- Clinical Monitoring and Oversight
- Centralized Statistical Monitoring
- Clinical trial data management services
- Statistical and Bioanalytical Support
- Regulatory Submissions
- Pharmacovigilance
We also provide dedicated clinical trial content management systems to support documentation, audit trails, and streamlined collaboration across global teams.
Modern Approaches to Clinical Trials
Decentralized Clinical Trials
Leverage digital tools and remote monitoring to improve patient access and retention across geographies.
Real-World Studies
Harness insights from patient registries and EHRs to evaluate treatment outcomes beyond the controlled trial environment.
With our scalable and adaptive solutions, we support a broad spectrum of modern trials while offering expert clinical trial project management plans tailored to your therapeutic area and development phase.
Meet us to learn more at
September 27 – 30 | SCDM 2025 Annual Conference
Biometrics Excellence at Navitas Life Sciences
Delivering Smarter Clinical Trials through Trusted Data Expertise
Navitas Life Sciences empowers pharmaceutical and biotech companies to advance clinical development with scientifically robust, data-driven insights. With over 35 years of proven expertise in clinical trial biometrics, including biostatistics, statistical programming, data management, and pharmacovigilance, we enable faster, compliant, and high-quality research execution across every phase of development.
Whether you need scalable Functional Service Provider (FSP) solutions or end-to-end support for a single trial, our flexible delivery models ensure rapid, cost-effective, and high-impact results.
Integrated Clinical Trial Services
From protocol design to final submission, our team ensures the seamless integration of clinical and statistical workflows. We deliver:
- Biostatistics and Statistical Programming – Leveraging both Frequentist and Bayesian frameworks to optimize study power, interim analyses, and adaptive design.
- Clinical Data Management – Ensuring quality-controlled data through centralized, remote, and risk-based models, with support for EDC, wearable, and ePRO devices.
- Medical Writing and Regulatory Submissions – Expertly crafted clinical documents including ISS/ISE, CSR, and integrated CTD modules to support timely approvals.
- Trial Rescue Services – Rapid assessment and stabilization of underperforming trials to ensure data integrity and regulatory alignment.
Flexible Resourcing to Fit Your Pipeline
Choose the model that best aligns with your development needs:
- Functional Service Provider (FSP) – Dedicated, scalable biometric teams integrated into your operations.
- End-to-End Support – Expert services delivered on a per-study basis for maximum flexibility and control.
Meet us to learn more at
- September 16 – 18 | POSIT:CONF(2025)
- September 20 | PHUSE India Single Day Event
- September 27 – 30 | SCDM 2025 Annual Conference
- October 13 – 14 | CDISC 2025 US Interchange
- November 22 | PHUSE India Single Day Event
Regulatory Affairs Services at Navitas Life Sciences
Accelerating Global Approvals with Regulatory Precision
Navitas Life Sciences provides comprehensive regulatory affairs services that support pharmaceutical, biotech, and medical device companies across the entire product life cycle. With a dedicated team of 250+ regulatory professionals, we provide strategic guidance and hands-on execution across a wide range of regulatory activities, helping pharmaceutical, biotech, and medical device companies navigate complex requirements with confidence. Our expertise spans biotech and pharmaceutical regulatory consulting services, medical device regulatory consulting services, and global submission management, ensuring timely and compliant filings across regions.
We also offer high-quality regulatory writing services, developing clear, accurate, and submission-ready documents that align with health authority expectations. Whether you're preparing for IND/CTA submissions, NDAs, BLAs, MAAs, or managing post-marketing variations, our integrated regulatory approach streamlines approvals, reduces risk, and accelerates time to market.
End-to-End Regulatory Support
Our services are built to meet the diverse needs of clients from pre-IND through post-marketing:
- Regulatory Strategy & Consulting – Scientific and regulatory guidance for clinical trial applications (CTA/IND), global development plans, and Health Authority interactions.
- Dossier Preparation & Submission – Authoring, compiling, and submitting high-quality regulatory documents including INDs, NDAs, MAAs, and ANDAs across multiple regions.
- Labeling & Life Cycle Management – Utilizing our labelREADY® platform, our cross-functional experts have a proven track record of managing end-to-end labeling services.
- Regulatory Information Management – We support data migration from your existing systems using our innovative rimREADY® tool, simplifying RIM operations and enabling accurate, fully-validated, and timely submissions.
- eCTD & Publishing Services – Fully compliant electronic submissions, including formatting, validation, and publishing.
Navitas Life Sciences hosts specialized regulatory networks like labelnet® and rimnet®, bringing together regulatory affairs professionals from leading life sciences organizations to collaborate on shared challenges. These peer-to-peer networks offer a trusted forum to exchange insights, benchmark performance, and stay abreast with current global regulations. Through focused discussions and well planned agendas, our networks empower members to drive efficiency and shape best practices in regulatory strategy and operations.
Meet us to learn more at
- October 27 – 28 | ExpertFORUM Labeling
- November 04 – 06 | Virtual Regulatory Network Forums
- November 11 | labelnet® Face-to-Face Forum
Pharmacovigilance (PV) Services
Global Drug Safety Oversight You Can Trust
Navitas Life Sciences delivers comprehensive pharmacovigilance solutions that span the full PV value chain, from case intake and processing to signal detection, risk management, and regulatory reporting. Leveraging over 30 years of experience in pharmacovigilance consultancy, we support pharmaceutical companies and biotechs in strengthening their safety systems, optimizing sourcing models, and upgrading IT infrastructure. Our global footprint across the US allows for flexible, scalable delivery models, combining efficiency with oversight. Backed by a skilled team of QPPVs, Safety Medical Experts, and PV Specialists, we offer tailored safety and pharmacovigilance services designed to meet compliance requirements and ensure patient safety across the entire product life cycle.
For over 20 years, Navitas Life Sciences has led the way in pharmacovigilance through our exclusive peer-to-peer networks. These independent communities, like pvnet® and pvconnect®, bring together safety leaders from top life sciences companies to share insights, benchmark performance, and co-create solutions. Designed to address real-world challenges, each network offers a trusted space for collaboration.
Meet us to learn more at
- November 04 – 06 | Virtual PV Network Forums
- November 05 – 06 | World Drug Safety Congress Americas 2025
- November 11 | pvnet® Face-to-Face Forum
- November 11 | pvconnect® Face-to-Face Forum
Partner With Navitas Life Sciences
Navitas Life Sciences is powering possibilities across the life sciences spectrum, offering integrated expertise in clinical trials management, cutting-edge clinical trial data management services, strategic regulatory consulting services, and end-to-end safety and pharmacovigilance solutions. From enabling smarter trials through AI-powered platforms to streamlining global submissions with expert regulatory writing services, and safeguarding patients with proven pharmacovigilance consultancy, our mission is clear: to help life-changing treatments reach patients faster and more effectively. Backed by decades of experience, global teams, and exclusive industry networks, we accelerate access to market.
To know more about our services and solutions, reach out to us at