Canal Row Advisors announced today that it has launched a new industry-leading Clinical Evidence Modernization Practice, aimed at guiding current and future clients on clinical development strategies that use real-world data (RWD), real world evidence (RWE), and artificial intelligence (AI) to accelerate patient-centric medical product development.
CANAL ROW ADVISORS LAUNCHES FIRST-OF-ITS-KIND CLINICAL EVIDENCE MODERNIZATION PRACTICE TO HELP CLIENTS USE REAL-WORLD DATA, REAL-WORLD EVIDENCE & ARTIFICIAL INTELLIGENCE TO ACCELERATE THE DEVELOPMENT OF SAFE, EFFECTIVE THERAPIES FOR PATIENTS
-- Industry-Leading Practice to Harness Recent Efforts by FDA to Advance the Use of Real-World Data, Real-World Evidence and Artificial Intelligence to Speed Drug Development for Patients --
BETHESDA, Md., Jan. 9, 2026 /PRNewswire-PRWeb/ -- Canal Row Advisors, a multidisciplinary team of former FDA and industry leaders with deep regulatory, clinical, compliance, and policy expertise, announced today that it has launched a new industry-leading Clinical Evidence Modernization Practice, aimed at guiding current and future clients on clinical development strategies that use real-world data (RWD), real world evidence (RWE), and artificial intelligence (AI) to accelerate patient-centric medical product development.
The new Clinical Evidence Modernization Practice is led by recognized expert Donna Rivera, PharmD., MSc., FISPE, who most recently served as the Director of the Oncology RWE Program and Oncology AI Program Lead at the U.S. Food & Drug Administration (FDA). She is joined by Elizabeth Duke, MD, a pediatric neuro-oncologist with extensive FDA review experience in pediatric oncology and rare diseases, including the use of RWE and external controls. Together, Donna and Elizabeth bring direct experience reviewing hundreds of applications incorporating these innovative designs.
Application of RWD, RWE, and AI have become increasingly valuable components of drug development in the United States over the last several years. While the longstanding use of observational studies to evaluate the safety of medical products is widely accepted, the enactment of the 21st Century Cures Act encouraged increased use of RWE for the evaluation of effectiveness to accelerate medical product innovation and resulted in the issuance of a suite of FDA RWE Guidances as well as establishment of the Advancing RWE Program.[i]
Moreover, the Agency is anticipating increased reliance on applications of AI in multiple aspects of drug development across the clinical trial continuum. Although reliance on these methods may be increasing, effective implementation of these strategies for regulatory acceptability can be challenging.
"RWD, RWE and AI offer tremendous opportunities to accelerate clinical development, but they are fraught with pitfalls that can complicate regulatory review. It is critical to design these programs correctly from the start. Drawing on their experience, our experts can help guide effective strategies to help speed patient-centric medical product development," said Hilary Marston, MD, MPH, Principal, Drug & Biological Therapies, Canal Row Advisors.
"As clinical development evolves, organizations are tasked with balancing scientific requirements and logistical feasibilities. Integrating data, technology, and methods, innovative evidence generation affords an opportunity for more efficient, streamlined approaches for patients, clinicians, and sponsors. We are building a practice to provide customized guidance across the continuum – pre-market to post-market -- from internal data strategy to portfolio and pipeline review to preparing regulatory submissions and designing pragmatic clinical evidence approaches. Our focus is on navigating modern evidentiary requirements and translating regulatory expectations into implementable strategies that accelerate the development of safe and effective therapeutics for patients," said Donna Rivera, PharmD., MSc., FISPE, Executive Vice President, Clinical Evidence Modernization, Canal Row Advisors.
Additional Details About Canal Row Advisors' Clinical Evidence Modernization Practice
The new Clinical Evidence Modernization Practice will provide current and future clients with end-to-end counsel and guidance on conceptualization, design, development and evaluation of real-world evidence for drug development, including:
Fit for Use Data
RWD Fit-for-Purpose Evaluation
- Data Source Selection
- Data Feasibility Analyses
AI and Data Science
- Product Development (e.g., eligibility, enrollment, matching)
Regulatory Acceptability
- Data Limitations and Missingness
- Bias Evaluation
- Model Risk and Performance
Fit for Purpose Design
Pre-Market Study Design
- Natural History Studies
- Observational Studies
- Early Clinical Trials (ECTs)
- Pragmatic Clinical Trials (PCTs)
- Decentralized Clinical Trials (DCTs)
Post-Market Evidence Design
- Registries
- PCTs
- Real World Evidence
Submission Guidance
- Protocol Review
- SAP Review
Fit for Review Evidence
Preparation for Successful Regulatory Engagements
- Alignment with FDA Requirements
- Appropriate Pathway (Accelerated, Traditional)
- Expedited Program Designation Requests (Fast Track, Breakthrough)
- Drugs and Biologics Submissions
- Device Submissions (including Software as a Medical Device)
Interpretation and Evaluation of Results
Regulatory Applicability and Flexibility (Oncology, Rare Diseases)
To learn more about Canal Row's new Clinical Evidence Modernization Practice, visit https://canalrow.com/clinical-evidence and follow Canal Row on LinkedIn for news and insights at Canal Row Advisors: Overview | LinkedIn.
About Canal Row Advisors
Canal Row Advisors supports life science leaders through pivotal FDA decisions with regulatory fluency, experienced foresight, and pressure-tested precision. Our cross-functional team of former FDA and industry leaders delivers full lifecycle guidance to navigate uncertainty, accelerate innovation, and uphold safety and public health at every stage.
To learn more, visit www.canalrow.com or and follow Canal Row on LinkedIn for news and insights at Canal Row Advisors: Overview | LinkedIn.
CONTACT:
Mark Marmur
Consultant – Dept. 11
(973) 906-1526
[i] FDA.gov. FDA Eliminates Major Barrier to Using Real-World Evidence in Drug and Device Application Reviews. FDA https://www.fda.gov/news-events/press-announcements/fda-eliminates-major-barrier-using-real-world-evidence-drug-and-device-application-reviews.
Media Contact
Mark Marmur, Canal Row Advisors, 1 (973) 906-1526, [email protected]
SOURCE Canal Row Advisors
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