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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 Analytics Director

With a solid educational foundation in pharmaceutical science and pharmacology at both the undergraduate and postgraduate levels, Yazi went on to earn a PhD in neuroscience. She then transitioned into a career in clinical research focused on medical devices, where she gained valuable hands-on experience in clinical trial design, organization, management, and regulatory processes. As a key leader in the Managed Access Real World Data (RWD) function, the Director of RWD Analytics will play a pivotal role in fostering insight-driven decision-making throughout the organisation. This will be achieved through the development of formal reporting systems, strategic analytics, and a commitment to delivering high-quality client services.

Natalie David, Natalie David, Real World Data Manager

With over 10 years of experience in data analysis, interpretation and presentation, Natalie has worked in the capacity of Statistician, Epidemiologist and Data Manager for institutions such as the NHS, Royal College of Surgeons of England and pharmaceutical companies including Amgen and BMS prior to moving to Clinigen in 2023. Natalie possess strong communication skills, both written and verbal and has a keen eye for detail.

Dr Hasan Kobat, Real World Data Business Lead

Hasan is a pharmacist with a profound expertise in clinical oncology. Armed with a PhD in this specialized field, he has devoted years to conducting real-world data studies that delve into the effectiveness and safety of cancer drugs in practical, everyday healthcare scenarios. He has experience in generating effective management and marketing strategies informed by RWD and clinical trial insights, ultimately driving evidence-based innovations in patient care and pharmaceutical solutions. He has deep-rooted commitment to a patient-centric approach, which can be leveraged to transition seamlessly into a client-centric mindset.