Newsletter | March 10, 2023

03.10.23 -- FDA Guidance Addresses Data Considerations For Externally Controlled Trials

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Clinical Data Management And Analysis
New FDA Draft Guidance Addresses Data Considerations For Externally Controlled Trials

The FDA recently released for public comment Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products. This guidance provides recommendations to sponsors and investigators, addresses considerations for the design and analysis of externally controlled trials, describes considerations related to communicating with the FDA, and ensures access by the FDA to data from an externally controlled trial.

Reduce Time, Cost, And Risk With Clinical Study Data Review Software

A Top 10 global biopharmaceutical company needed to implement a single clinical study data review system to reduce the time, cost, and risk of running their clinical trials while accelerating the time-to-market. The company deployed PerkinElmer's interactive data visualization and analysis solution, which is quickly becoming the tool of choice for clinicians and safety reviewers.

The AI Revolution In Multivigilance

Explore how the life sciences industry is undergoing dynamic change thanks to advances in science and engineering.

How An AI/ML Data Strategy For Life Sciences Can Deliver Better Business Outcomes

Explore how data science and artificial intelligence/machine learning (AI/ML) driven predictive and prescriptive insights can help research teams cut time and cost.

Data Pitfalls In Oncology Clinical Trials And How To Avoid Them

Researchers are often faced with the challenge of preventing data management drawbacks in oncology clinical trials. Explore new recommendations to ensure successful final delivery of quality study data.

Creating A Successful ML Data Governance Strategy

Thanks to clinical discoveries and technological advancements, the industry has witnessed an unprecedented surge in data. Consider these key principles when developing and implementing machine learning governance policies.

A Comprehensive Solution For Clinical Research

As the industry's leading provider of eSource to EDC integration, explore how CRIO gives you complete control over your clinical data.

Patient Over Process: The inSeption Group Difference

Everything we do is driven to challenge the status quo in the current outsourcing paradigm. inSeption is a home for clients and professionals who have been stifled by mainstream, high-volume, commoditized outsourcing models.

2023 PDA Advanced Therapy Medicinal Products Conference

The 2023 PDA Advanced Therapy Medicinal Products Conference, June 7-8, in Baltimore, MD, will focus on the theme, "Navigating through CMC Challenges." This popular conference will offer a forum for sharing best practices and learning from the experts how the industry is applying novel approaches to a wide variety of topics relating to cell and gene therapies. Register now!

Trial Monitoring
The Long-Term Impact Of COVID-19 On Monitoring And Other Trial Processes

Pandemics provide a massive pressure-test of healthcare systems, allowing us to isolate what works well and what merits improvement. The COVID-19 pandemic is going to create a “new normal” regarding resetting the equilibrium in a variety of policies, procedures, and processes. In Part 1, we examine five factors that more directly impact the clinical trial process and patients.

Expecting The Unexpected: Strategies For Efficient Clinical Supply Management And Forecasting

Explore how to utilize forecasting to better plan clinical supply budgets and project timelines and to identify potential supply-related issues before they negatively impact your study.

First Pivotal Trial With Data From Wearables As FDA-Endorsed Primary Endpoint

Bellerophon Therapeutics, a clinical stage biotherapeutics company focused on developing treatments for cardiopulmonary diseases, was able to save their clinical development program through the use of objective, continuous digital outcome measures.

What Happens When Your CRO Is Acquired? A Vendor Oversight Approach And Response

This paper looks at the growing merger and acquisition (M&A) trend and discusses how investing in vendor oversight services can ensure quality, timeliness, and peace of mind.

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