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Conference: 2025 ISPE Annual Meeting

Date: August 22 - 26, 2025

Location: Washington, DC

Booth: 303

Learn more about Certara’s innovative approach to studying rare diseases

Addressing complex challenges associted with rare disease drug development and evidence generation requires an innovative approach. Visit Certara at booth #303 at the 2025 ISPE Annual Meeting to connect with our real-world evidence and pharmacoepidemiology experts to hear more about we’re linking rare disease registries with national health claims databases to overcome issues related to limited and incomplete data and help our customers assess the burden of illness.

Case Study: Assessing the burden of illness in Hemmorrhagic Stroke

Challenge(s):

  • Limited data availability due to rarity of condition
  • Locating small and dispersed patient populations
  • Incomplete data sources that lack all necessary variables to study, e.g., outcomes and resource utlization but not quality of life or clinical measures.

Solution: Certara’s Real-World Evidence team use an innovative approach to link retrospective chart review studies as well a rare disease registry to the SNDS French National Health Claims Database to obtain a better understanding of rare genetic disorder progression and identy unmet needs.

Where to hear Certara insights and expertise

Date: Sunday, August 24
Time: 12 – 1:30 p.m. ET

Presenting author: Artak Khachatryan

Co-author(s): Malgorzata Ciepielewska, Aastha Chandak, Alekhya Lavu, Polina DaSilva

Date: Tuesday, August 26
Time: 12 – 1:30 p.m. ET

Presenting author: Alekhya Lavu

Co-author(s): Malgorzata Ciepielewska, Aastha Chandak, Polina DaSilva, Gaelle Gusto, Vishnu Sarda, Kalyani Kankanampati, Artak Khachatryan

Explore Certara's RWE Services

  • Outcomes Research and Surveys: Analyzing treatment patterns, patient outcomes, and unmet needs in niche populations to inform development and market access strategies
  • Data Source Selection: Identifying and selecting the most appropriate real-world data sources (e.g., patient registries, medical records, claims data) to address specific research questions
  • Advanced Analytics and Modeling: Applying sophisticated analytical techniques to RWE to extract meaningful insights, including comparative effectiveness studies, cost-effectiveness analyses, and safety evaluations.
  • Regulatory Support: Providing regulatory writing, strategy, and submission expertise to support rare disease drug approvals.
  • Market Access Strategies: Developing strategies to optimize pricing, reimbursement, and market access for rare disease therapies.