Parexel Blog
Parexel Blog
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Learn MoreLeveraging the draft FDA Guidance on PBPK for your drug development program
In October of 2020, the Food and Drug Administration (FDA) issued draft guidance for the pharmaceutical industry on The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics...
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Learn MoreWe need faster endpoints for targeted cancer drugs, and there is one
As a former regulator, Jorge shares his perspectives for the need of more faster endpoints to measure how targeted cancer drugs can benefit patients. He believes it can be created by combining two...
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Learn MoreThree ways to improve your chances that insurers will pay for a new CGT
When developing cell and gene therapies (CGTs), drug companies face significant hurdles. One of which is getting insurance companies to pay for these treatments that can potentially cure patients...
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Learn MoreThe Parexel Podcast | Episode 15: Pandemic preparedness: Investing in the future of infectious disease vaccine development
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Learn MoreHow market exclusivities can affect your development program
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Learn MoreRegulatory considerations from former FDA regulators
In this infographic, we’ve compiled some common questions our ex-FDA experts get asked, along with their perspectives.
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Learn MoreCreating an effective cell or gene therapy communications strategy
In this infographic, we have outlined some engagement activities that can enhance your cell or gene therapy development and inspire your stakeholders.
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Learn MoreGetting the small steps right for our biotech customers to make an exponential difference in patients’ lives
Biotech companies are the driving force behind the industry’s R&D pipeline as they develop and launch increasingly complex treatments. With more than 80% of the assets in development managed by...
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Learn MoreEpisode 14: Why Parents and Children Join Research Studies: CISCRP’s 2020 Pediatric Perceptions & Insights Survey Reveals Critical Insights
Pediatric participation in clinical trials is essential to understanding how drugs perform in children, whose side effects and responses to medications are often very different from adults. Yet...
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Learn MoreChallenges of 2020: Lessons for Clinical Trials in Diabetes
The extraordinary challenges of 2020—the global pandemic and the renewed campaign against racial injustice—have simultaneously presented opportunities for significant growth and change across the...
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Learn MoreFostering steady advances in data operations: FSP partnerships can spur and support change
When we discuss innovation in clinical trials, it’s easy to think first of technologies involving digital health or evolving tools such as augmented intelligence. And these are certainly...
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Learn MoreDrug Development for Rare Disease and Oncology During the COVID-19 Pandemic
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Learn MoreThe Evolving Cell and Gene Therapy (CGT) Sector in China
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Learn MoreVirtual meetings are easy, right?
Recommendations for navigating the "new normal" and how to prepare for the future.
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Learn MoreOptimizing SOPS in the Digital World
For any company on the receiving end of an FDA 483 or warning letter, standard operating procedures (SOPs) represent an opportunity to simultaneously achieve compliance and improve operational...
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Learn MoreFive points to remember if FDA issues a Form 483
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Learn MoreThe impact of COVID-19 on clinical trials in rare disease and oncology
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Learn MoreThe Move Toward Global Standards: Navigating New EAEU Guidelines
As the pandemic clearly revealed, there is an urgent need for a more cohesive, coordinated approach to streamline global regulatory guidelines to ensure patients have faster access to new and...
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Learn MoreThe Special Approval Pathway (SAP) for COVID-19 related products in China
The regulatory pathway for COVID-19 drugs in China is governed by the Special Approval Program (SAP) which was introduced by National Medical Product Administration (NMPA) in 2005. SAP is...
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Learn MoreNMPA Guidance on the Management of Clinical Trials during the COVID-19 from July 2020
Conducting clinical trials during the COVID-19 pandemic has produced many challenges globally. The initiation, conduct, implementation and completion of a trial during this time requires special...
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