Can external/synthetic control arms address regulator and HTA evidence requirements?

Live Panel Discussion

Parexel and MorphoSys experts join forces to share their perspectives on how regulators and payers view external control arms. They will discuss key takeaways from their pioneering efforts to incorporate these data models in submissions and learnings from the complete patient experience to overcome approval and access barriers.

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Navigating Long COVID Syndrome

During this time, we continue to be committed to our customers’ business while putting the safety of patients, partners and our employees at the heart of everything we do.

Long COVID Syndrome

COVID-19 Response

COVID-19 Data Clearinghouse

Risk-based Quality Management (RBQM) Services

The new world order of clinical research demands a fresh look at end-to-end clinical practices. Parexel’s approach to risk-based quality management (RBQM) is a holistic risk strategy rooted in Quality by Design principles, that relies on critical data to inform decision-making throughout clinical programs and trials.

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The future of real-world evidence with Dr. Scott Gottlieb

Dr. Scott Gottlieb, Former Commissioner of the Food and Drug Administration, and industry leaders met recently for a roundtable discussion with Parexel and Pharmaceutical Executive to discuss the current and evolving role of real-world evidence for regulatory approvals and drug development.

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Regulatory & Access Consulting

Connect with an expert from our 1000+ strong Regulatory & Access consulting team to see how our integrated expertise can strengthen your development strategy. Our consulting group includes ~100 former regulators/HTA assessors alongside industry luminaries - experts that apply first-hand knowledge of how regulators and payers think to help you foresee and address regulatory and market access hurdles. Our team never stops, relentlessly searching for solutions, because patients can’t wait.

See our insights in action

Regulatory & Access Consulting

Connect with an expert from our 1000+ strong Regulatory & Access consulting team to see how our integrated expertise can strengthen your development strategy. Our consulting group includes ~100 former regulators/HTA assessors alongside industry luminaries - experts that apply first-hand knowledge of how regulators and payers think to help you foresee and address regulatory and market access hurdles. Our team never stops, relentlessly searching for solutions, because patients can’t wait.

See our insights in action