Non-Interventional
Studies

Ensuring you gain the best from your clinical data

Rely on our Proven Expertise for Successful Outcomes for your Non-Interventional Studies

Non-Interventional Studies (NIS) are helpful to examine the safety, tolerability and effectiveness of your medical product in market. Important findings like drug interactions, side effects, patience compliance, quality of life improvements and much more may be discovered through NIS. Such findings enable you to leverage your product to the maximum and improve the lives of patients.

Most NIS do not follow a unified protocol, requiring specialized skills to run a NIS trial. Running such trials requires expertise in handling real-world situations, and dealing with tricky situations like patient non-compliance, inaccurate dosing or application. Source data collection across multiple health centers is also tricky and many a time, data from NIS trials are inconsistent, non-homogeneous, and even missing!

Navitas Life Sciences is Your Partner in Non-Interventional Studies

Experience

Experience

400+ NIS Studies
Expertise

Expertise

Dedicated & Experienced NIS CRAs
Technology

Technology

Proprietary NIS EDC (OneClinical Lite)
Approach

Approach

Exclusive NIS SPOC
Processes

Processes

SOPs specifically for non-GCP NIS
Quality

Quality

BVMA & CDISC Member

Comprehensive NIS Capabilities to Meet Your Specific Needs

End-to-end Services from Study Setup to Closure

Wide Range of Therapeutic Expertise including Oncology & Neurology

Ability to handle both small studies and large studies ranging from 50 to 26,000+ patients

Extensive Geographical Coverage of Europe, CIS and Turkey with localized expertise

We Support Your End-to-End NIS Requirements

Study Design


Design & plan your prospective or retrospective study with our experts to ensure successful outcomes

Study Conduct


Your non-interventional studies are conducted in real life situations, requiring the right experience and expertise for successful completion

Data Standardization & Analysis


Expert biostatisticians are available to standardize and analyze your study data

Regulatory Submissions


Our regulatory submissions services are backed by a cutting-edge technology platform that enables first-time-right submissions and follow ups.

Pharmacovigilance


Bring patient safety to the forefront with our expert pharmacovigilance services and systems

Study Closure


Well-handled study closures with focus on data cleaning; country, and site closure procedures, Final QC of files, and publications

Drive Successful Outcomes for Your NIS Studies with our Expertise Across Multiple Study Types

We have conducted various types of studies, from market surveys, pre-launch screenings, classical Non-Interventional Studies, post-authorization safety studies, and post authorization effectiveness studies. We have helped our clients collect prospective and retrospective data for marketed products, evaluate product effectiveness, patient compliance, patient/physician satisfaction; identify, characterize and quantify safety hazards; confirm safety profile of medicinal products; and even measure the effectiveness of risk-management measures. We cover all aspects of post-marketing safety services, including generation of ICSRs, query management, ICSR to CA and Eudravigilance, and periodic safety reports. Our insight and understanding about each aspect of non-interventional studies, helps us deliver high quality outcomes to meet your specific needs.

  • Market Surveys
  • Pre-Launch Screening
  • Post Authorization Safety Studies (PASS)
  • Post authorization Efficacy Studies (PAES)
  • Traditional Non-Interventional Studies (NIS)
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Learn more about how we can help your
Non-Interventional Studies