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THERAPEUTIC EXPERTISE

Late Phase Studies

At Linical we understand the challenges surrounding late phase clinical research and provide expert guidance for successful Non-Interventional Studies (NIS).

We support sponsors in providing optimal study designs following NIS-specific SOPs and processes, and provide real-world evidence (RWE) specific training program for team members.
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PHASES

Real-World Evidence and Non-Interventional Studies

Real-world evidence (RWE) is playing an increasing role in health care decisions and there is major potential to increase the use of RWE to support lifecycle product development and to assist decision-making for regulators, payers, healthcare professionals (HCP) and patients.

In contrast to clinical trials, Non-Interventional Studies (NIS) reflect how a product is used in daily medical practice. By following patients in the real world, observational studies gather additional data that was not available at the time of the drug being marketed.

Late Phase CRO Services

Linical has decades of experience conducting Phase IV clinical trials including observational studies. Our specific late phase study plans incorporate NIS-based site selection and strategic regulatory approaches. We also provide an operational and monitoring model that is tailor-made for observational studies to ensure project success.

Our highly specialized team has specific expertise and provides guidance and key strategies to design and conduct successful Non-Interventional Studies.

Our late phase clinical development services include:

  • Cohort Studies
    • Prospective: Registries (Disease or Product)
    • Retrospective: Chart Review Studies
  • Case-controlled Studies
  • Post-authorization Safety Studies (PASS)
  • Drug Utilization Studies (DUS)
  • Risk Minimisation Measures Surveys
  • Health Economics and Time & Motion Studies
  • Secondary Database Studies

Explore Linical’s Late Phase CRO Services

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Drug Development Strategy

Drug Development Strategy

Linical provides comprehensive solutions for drug development strategy, including regulatory affairs, protocol development and study design, medical writing, and quality assurance.Through assessing scientific, regulatory, and commercial considerations, Linical works in collaboration with clients to optimize your trial’s drug development strategy.
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Clinical Trial Management

Clinical Trial Management

Linical’s comprehensive clinical trial management services are designed to help your program achieve high-quality data, on time and on budget. From study start up and feasibility, to project management, biometrics, and drug safety, Linical has the flexibility and experience you need.
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