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Building a comprehensive understanding of a medicine goes beyond clinical trials.

Collecting Real World Data (RWD) within a Managed Access Program is a critical opportunity, especially when dealing with unlicensed medicines.

Here’s why:

  1. First Real-World Observations: Unlicensed medicines often lack extensive real-world data. Managed Access Programs often provide the first opportunity to observe how these medicines perform outside of controlled clinical trials. This early exposure helps uncover valuable insights.
  2. Safety and Efficacy: RWD collected during early access allows us to monitor safety and efficacy in diverse patient populations. It helps identify any unexpected adverse effects or benefits.
  3. Optimizing Usage: Understanding how healthcare professionals and patients use the medicine informs optimal dosing, administration, and patient management.
  4. Demonstrating Value: RWD helps identify what data best demonstrates a medicine’s value. It provides insights into patient outcomes, safety, and effectiveness beyond the controlled setting of clinical trials.
  5. Reimbursement and Market Strategy: Companies need evidence to drive reimbursement decisions and market launch strategies. RWD informs pricing, access, and market positioning.

Here’s how Clinigen supports RWD collection:

  • Light-Touch Data Collection: Clinigen’s online platform simplifies data contribution for physicians and patients. It supplements Health Economics and Outcomes Research, market access strategies, and reimbursement efforts.
  • Data Analytics: Clinigen’s skilled data analytics team provides meaningful analysis and custom reports at key program stages. This ensures informed decision-making.

The result? Medicines are used optimally, regulatory approvals are timely, and pricing aligns with value. 

Global experts

Dr Yazi Al’Joboori, Real World Data Business Lead

Dr. Yazi Al’joboori joined Clinigen Group in 2021. Her role is designed to bridge the gap between the business development and the Real World Data operational delivery teams. After studying pharmaceutical science and pharmacology at an undergraduate/postgraduate level, she proceeded to pursue a PhD in neuroscience with her doctorate centred on the pre-clinical research into the combined use of implantable spinal stimulators and plasticity enhancing gene therapy to facilitate recovery of stepping in severe spinal cord injury. She then progressed into a career in clinical research with assistive devices at University College London (UCL) where she gained hands-on experience in clinical trial design/organisation, management and regulatory procedures with non-CE marked medical devices. Yazi has a passion for analytical problem-solving and enjoys working as part of a multi-functional team to support program delivery.