Newsletter | November 16, 2020

11.16.20 -- Getting A Handle On Clinical Trial Costs

 
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Handling The Specialized Data Requirements In Oncology Clinical Trials

The right design and the right data ultimately lead to the right decisions, so obtaining fit-for-purpose data, collected based on what your protocol is looking for, is vital. However, there are several data pressure points facing oncology drug developers that need specialized expertise and processes to handle. In this blog, we run through some key aspects to consider to smooth your data collection and analysis.

Developing A Clinical Trial Budget Following Medicare’s Clinical Trial Policy And Device Regulations

There are many challenges involved in developing and negotiating a clinical trial budget that applies Medicare’s rules and regulations for device and drug clinical trials. In Advarra’s blog, we’ll discuss these challenges and suggest strategies to assist with this process.

Actigraphy For Breast Cancer

Actigraphy is the measurement of motion used to monitor 24-hour activity patterns. Read how actigraphy was used in breast cancer studies to track sleep patterns and circadian endpoints, as well as using datasets provided to investigate mathematical patterns that may be responsive to pharmacological therapy.

Using Remote Clinical Research Site Monitoring During COVID-19

Here are some of the challenges that research sites and monitors are facing right now — and how they can overcome them with remote monitoring.

Making Data Central To Your CNS And Pain Trials

Central nervous system (CNS) and pain trials are demanding from a data capture standpoint: Complicated eligibility criteria, extensive monitoring requirements, comprehensive data collection, and substantial demands on patients all must be overcome. After consulting with key opinion leaders from CROs and pharma we learned the solution was a product with a well thought out functionality specific to the therapeutic area, coupled with highly consultative, experience-based guidance that ensures clients receive a complete data collection solution that fulfills their exact needs.

Cold Chain Industry Trends: Planning Tips To Create A Robust Supply Chain

The maintenance of cold chain product integrity across the entire supply chain demands rigorous processes and cold chain expertise of the highest caliber — from packaging, handling, storage, and distribution of temperature-sensitive investigational medicinal products (IMPs) all the way to the investigator site. This ebook provides an industry overview and a framework for discussion. The importance of a robust supply chain is addressed. It includes planning recommendations for biopharmaceutical companies preparing to scale up to global vaccine trials.

AI Research Can Optimize Clinical/Operational Effectiveness

“One critical area when you look at healthcare systems is the issue of optimizing clinical and operational effectiveness,” suggests Professor John Lim, founding executive director of the Duke-National University of Singapore Centre of Regulatory Excellence (CoRE). “This is an area where research in AI is developing to really inform and aid decision-making not only by physicians but also operational decisions by healthcare providers.” Professor Lim is also chairman of the Singapore Clinical Research Institute and National Health Innovation Center.

Empowering The Clinical Trial Sponsor With Analytics

Clinical development teams often rely on outside contracted organizations to provide data or analyses. These sponsors are under enormous regulatory scrutiny. Join Houston Gilbert from Arcus Biosciences, along with experts from PerkinElmer, to learn how Arcus Biosciences, an oncology-focused biopharmaceutical company, tackled the data quality and oversight challenges they faced with their CROs and how they enabled their clinical teams with self-service analytics.

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