Biosimilars Studies

Delivering Results for Biologics & Biosimilars Manufacturers

With patents expiring on all of the top 30 biological drugs before 2025, this is an exciting time for Biosimilar launches. To be first to file, Sponsors require a partner with advanced technical and regulatory expertise. The main considerations for a sponsor while selecting a partner to enable successful biosimilar study are:

  • Extensive clinical experience to monitor and treat potential severe adverse responses to biosimilar drug
  • Ability to design lean protocols to gain market approval as efficiently as possible
  • Focus on cost efficiency to capture market share
  • Track record of meeting regulatory requirements for study quality remain as high as innovator research

Navitas has Proven Expertise with Biologics and Biosimilars

With a global presence, our experience across innovator pharma and biologic Phase III studies, and pharmacokinetic studies enables us to partner with you to meet accelerated submission timelines while optimizing trial costs and regulatory risk of non-compliance.

  • Accelerated onboarding of healthy volunteers from our 20,000+ database, including geriatric age range
  • Access to specialty hospitals with patients in oncology, psychiatry, dermatology, diabetes and renal impaired patients
  • Rapid set-up possible with tailored multi-analyte methods ready in 4-5 weeks. Library of pre-validated assays in 10+ matrices including skin and bone
  • 100% adherence to regulatory guidelines with an independent QA department, SOP’s, training and audits
  • ISO 9001 certified Quality Management System
  • FDA 21 CFR Part 11 compliant computer systems for sample and data analyses
  • Bioanalytical labs at the forefront of technology and analytical capability, CAP and ISO-15189 accredited
  • Computer system validation for data management processes
  • Fingerprint-based cross-volunteer participation software to detect overlaps with parallel studies
  • Cost-effective location with no competing facilities in the region, leading to exclusive subject access in catchment area
  • Optimized and efficient trial conduct and analysis platform, OneClinical

Our Clinical Trials Services are Powered by OneClinical

Our OneClinical technology platform drives successful outcomes for global trials by ensuring better trial oversight at subject/site/country/study levels, delivering high-quality data in near real-time, enabling faster decision making and minimizing risks to trial success.

  • global-trials-management

    Global Trials Management

  • better-oversight

    Better Oversight

  • near-real-time-data

    Near Real-time Data

  • informed-decisions

    Informed Decisions

  • minimized-risk

    Minimized Risk

  • successful-outcomes

    Successful Outcomes

Designed for and delivered via cloud and in compliance with regulatory and data privacy requirements, OneClinical provides end to end clinical trial data management, data visualization, analytics, monitoring and submission services. Proven across a variety of global trials, the cloud platform offers short setup time with low fixed costs, and provides global accessibility with near real-time-time data analytics and visualizations. Beyond monitoring, OneClinical also provides Site Payments, Study Budget Scenario Planning, Interactive Contracts and Payments dashboards.

Powered by modern technology architectures, OneClinical provides quality by design, effective oversight of trials and actionable insights through comprehensive data visualization. OneClinical reduces source data verification through industry standards driven central, remote and risk based monitoring, and enables Data Review, Query Reconciliation and Management through a configurable workflow based solution.

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