Newsletter | January 12, 2022

01.12.22 -- Trends To Watch In 2022: RWD, DCTs, And Cell & Gene Trials

 
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Keys To Successful Risk Management In Clinical Trials

Effective risk management recognizes variables unique to each clinical trial while embracing consistent documentation practices, stakeholder responsibility, and best practices informed by experience.

Impact Of A Pandemic Outbreak On Vaccine Development Approach

Several challenges with traditional vaccine development methods must be overcome in order to reduce the timeline for vaccine distribution.

Analysis: Pharma’s Path Ahead For COVID-19 R&D

Three pressing issues stand out and require the collaborative efforts of the biopharma industry to slow the pandemic, reduce deaths and hospitalizations, and return life to something that resembles normality: understanding long COVID-19, growing the arsenal of anti-infectives, and tackling virus variants.

What My Experience In A COVID-19 Vaccine Trial Taught Me About The Need For Greater Patient-Centricity

Kelly McKee, vice president of patient registries and recruitment at Medidata, recently participated in a COVID-19 vaccine trial. Despite over two decades of experience in clinical trial operations and patient recruitment, this was her first experience as a participant. In this first-person blog, Kelly reflects on the many opportunities clinical trials still have to become more patient-centric.

How One Clinical Data Manager Supercharged A Clinical Trial

Clinical data managers sit at the intersection of busy information highways in clinical trials. But they do more than just direct traffic. Learn how this information can be managed in the available Q&A with Justine Pierson, a battle-tested clinical data manager.

Back To Basics: 505(b)(2) FAQs Part 3 — Regulatory Strategies

As the 505(b)(2) expert, Camargo is frequently asked questions about how to get a product approved via the 505(b)(2) regulatory pathway and if this pathway is appropriate. Here is Part 3 in the series of frequently asked questions (FAQs).

Real-World Evidence Breakthrough In Russia: Regulatory Sandbox For The Compliant Use Of Big Data

As a result of an all-around digitalization of healthcare in Russia, real-world data is being accumulated in digital medical systems, allowing them to be used for real-world evidence research.

Quality Metrics: How To Add Value And Meet The FDA's Expectations

Quality metrics have been widely used in the pharma industry to monitor quality systems and operational processes, and to promote continuous improvement initiatives in drug manufacturing.

Overcoming Barriers To Embracing Data

Are we effectively using the abundance of data available in the industry today? Uncover the importance of building a data-driven organization and the steps to embedding data into your organization’s identity.

Decentralized Clinical Trials: How To Deliver The Complex Efficiently

COVID-19 has had a huge impact on the clinical trials environment, especially in highlighting the weaknesses of the traditional site-centric clinical trial designs. Read how decentralized clinical trials may be the solution.

Disrupting The Clinical Trial Enrollment Process

Clinical trial recruitment and enrollment is an area ripe for disruption. Despite the huge expenditure, the recruitment process has been and, in many cases, continues to be inefficient. Read how this can change in the available white paper.

Fireside Chat With Lisa Conte

Hear how founder, president, and chief executive officer of Jaguar Health, Lisa Conte, successfully did what one in 2,000 biotech companies are able to do: bring Mytesi® from discovery to commercialization.

Moving Beyond 10 Steps To Clinical Study Start-Up

Today, study start-up functions and job roles are more commonplace at sponsor and CRO organizations, but despite this, clinical operations teams are drowning in data while starving for information at a time of intense pressure to speed up clinical trials and restrain costs.

Rethinking Patient Engagement In Oncology Studies Webinar

This webinar describes a new framework for retaining and engaging participants in long-term oncology studies.

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