RBQM is our future: Using holistic risk-based oversight, we can focus on a trial’s most critical factors

Recently, RBQM experts offered ideas of what’s ahead. RBQMLive, hosted by CluePoints, featured 18 industry leaders and welcomed more than 700 attendees from 27 countries. We discussed the current...

Putting AI to work in your safety program

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Decentralized Trials: Considerations for Building a New Patient-Centric Model

During the past year, patients around the world waiting for new treatments have taken heart that clinical trials have been ongoing, despite the enormous logistical challenges posed by the...

Tips for building your oncology reimbursement strategy

In this infographic, we share five tips for building an effective reimbursement strategy for your oncology product.

101 guide for real-world evidence

We have created this guide to simplify the terminology of real-world evidence (RWE) and outline some of the strategic options available.

PBPK modeling solutions as a potential risk mitigation strategy for pH dependent DDIs

Drug- Drug Interaction (DDI) is a crucial aspect in new drug development due potential impact on patients’ safety. Pharmacokinetic interactions at the level of absorption, distribution, metabolism...

On the precipice of an impending avalanche of regulatory compliance activity: Are you prepared?

The COVID-19 pandemic brought into sharp focus the vulnerabilities in supply chains for medical products and the importance of ensuring their integrity to provide patient access to critical...

Leveraging 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In October of 2020, the Food and Drug Administration (FDA) issued draft guidance for the pharmaceutical industry on The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics...

We 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...

Three 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...

The Parexel Podcast | Episode 15: Pandemic preparedness: Investing in the future of infectious disease vaccine development

How market exclusivities can affect your development program

Regulatory considerations from former FDA regulators

In this infographic, we’ve compiled some common questions our ex-FDA experts get asked when helping customers build their cell and gene therapy strategy.

Creating 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.

Getting 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...

Episode 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...

Challenges 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...

Fostering 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...

Drug Development for Rare Disease and Oncology During the COVID-19 Pandemic

Virtual meetings are easy, right?

Recommendations for navigating the "new normal" and how to prepare for the future.