Cancer thriver and rare disease care partner Stacy Hurt is Parexel’s first Patient Ambassador and “secret weapon” to develop patient-centric clinical trials.
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Clinical research lacks workers — but in FSP, we’re training the professionals we need
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As decentralized trials gain prevalence, clinical supply chains can flex to meet new needs.
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Just because the COVID pandemic disrupted business operations, the importance of data integrity in manufacturing has not diminished. Accurate data is the foundation of product quality. How can...
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Over the past decade, there has been a proliferation of real-world data (RWD) sources that sponsors can use to generate real-world evidence (RWE) for a wide range of purposes across the product...
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Julie has spent more than 25 years advocating for patients with chronic diseases, both professionally and personally. She has extensive experience in recruiting, engaging, and retaining patients...
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Empowered patients are the touchstone of modern healthcare. Yet, in a highly regulated industry, with scores of stakeholders, novel scientific questions and methodologies, emerging technologies...
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Across the clinical research community, we’re working toward creating more inclusive studies. By recruiting and supporting patients from underrepresented communities, we help ensure equitable...
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In every clinical trial, risk management is a must. However, it can start to feel routine: add some lines to a spreadsheet, move on to the next risk, and check the box that risk management is...
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Chris Learn, Ph.D., PMP, recently joined Parexel as Vice President, Head of the Cell and Gene Center of Excellence. During Chris’ first week, we asked him to share his professional experiences,...
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Drug development is a complex business. Historically, less than 8% of product candidates are reported to have made it from Phase I to market. One effective way to mitigate risk is to weed out weak...
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Our world is multiracial, multicultural, and multi-ethnic. Delivering meaningful communications that resonate with as many people as possible is important to embrace diverse thinking. Using...
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For payment systems to evolve to deal with reimbursement and market access challenges, payers are taking a new look at evidence generation and data usage. Medicines are so specialized today that...
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During decades in this industry, I've seen biotech funding fluctuate. Right now, financings, deals, and M&As are blazing hot. In my experience, companies that raise money when they can but...
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Choosing a partner to successfully navigate the next five years
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The shortcomings of traditional study designs have come into sharp relief during the COVID-19 pandemic. Regulatory agencies and the research community alike have responded, acknowledging the need...
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Innovation is the lifeblood of research and development in any industry. Scores of industry efforts spanning digital therapeutics, data sciences and decentralized clinical trials represent the...
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The FDA released a draft guidance that outlines regulatory considerations for INDs that study multiple versions of a cellular or gene therapy (CGT) product in a single trial. There are some...
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In this article, Regulatory expert, Cecil Nick, looks at the latest MHRA guidance and what the future holds for biosimilar development.
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A major challenge in drug development is the translation of candidate molecules from the preclinical phase to the clinical setting. The key elements to be considered are the pharmacology,...
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