Newsletter | September 8, 2021

09.08.21 -- Could An Incentive-Based Pricing Model Improve CRO Performance?

Featured Editorial
Industry Insights
Better Experience, Better Results: 5 Must-Haves For Any Decentralized Trial

In this blog, the must-haves for decentralized trials are discussed through the lens of a breast cancer survivor.

Delivering The Full Value Chain For Oncology Clinical Trials

Oncology clinical trials are always challenging, and clinical approaches and the needs for supportive services continue to evolve. Partnering with the right contract services organization that is committed to putting patients first is critical.

Overcoming Trial Master File (TMF) Artificial Intelligence Challenges

Document management related to the TMF is time-consuming and prone to error, requiring highly experienced professionals to perform mundane and repetitive tasks, such as filing and indexing documents. This blog reviews our journey to create a machine learning framework built specifically for the pharmaceutical industry on the TMF to assess what improvements in speed and accuracy we could obtain through AI-powered automation.

Considerations When Outsourcing Your Packaging Operations

In this Q&A we dig into some of the essential elements our experts identify as key to maintaining and enhancing both existing and new partnerships. Learn how outsourcing this key aspect of bringing your product to market can benefit your organization and overall supply chain optimization.

Sponsor Reimbursement Tips

Read the available download for recommendations to include in a grant/sponsor contract to recover the cost of an eRegulatory clinical trial solution.

Hybrid Trials Are Here To Stay

Hybrid trials. Decentralized trials. Remote trials. Virtual trials. No matter what you (or anyone else) calls them, the rapid uptake of trials in which patients participate from home for some visits/activities, rather than exclusively in a clinical setting, has been a game-changer for continuing clinical research in the face of the COVID-19 pandemic. Though the industry has yet to settle on a uniform terminology for this type of trial, it does seem as though the industry is aligned on its expectations for the future of these trials.

It Takes Two: The Importance Of Study Partners In Alzheimer’s Disease Clinical Trials

Alzheimer’s disease currently afflicts close to 50 million people worldwide, highlighting the importance of clinical trials for this condition. Alzheimer’s studies are unique in that they require an additional participant to assess the patient’s mental and physical health during the trial. But what are the characteristics of a viable study partner?

RBQM Is Our Future

Let’s talk about the future of clinical trials. There’s no crystal ball, but we have plenty of data — and they show the growing need for risk-based quality management (RBQM) in clinical research. In this blog we discuss the current clinical trials landscape, the factors driving change, and why the industry is embracing the RBQM model.

Rethinking Your Imaging Strategy
The current state of the clinical trial imaging industry can best be described as murky and unsettling, and it could put your timelines at risk. This guide is designed to help you avoid the pitfalls in this disrupted landscape. Across eight parameters, learn how you can regain control of your imaging strategy and leap ahead in the transformation of imaging for your trials.
FDA Expedited Pathways

The FDA has issued regulations and guidance documents to establish development programs designed to speed the availability of new therapies to patients with serious conditions, especially when there are no satisfactory alternative therapies. This infographic highlights the benefits, qualifying criteria, and timing and procedures for six different expedited programs and designations. 

Human Radiolabeled Mass Balance (hAME) Studies For Regulatory Submission Part 1

In this webinar, we provide a comprehensive overview and practical guide to get the most out of your hAME study, covering the many nuanced steps and considerations.

Orphan Drugs: Balancing Financial Incentives And Complex Challenges

Whether your orphan drug is a small or large molecule, there are key strategies that you can adopt to enable a seamless transition from early development into commercial manufacturing, while also balancing your investment.


Virtual Event | October 5, 2021, 10:00 a.m. – October 6, 2021, 5:00 p.m.

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