Newsletter | June 20, 2022

06.20.22 -- AstraZeneca's Oncology Goal: Separate Efficacy And Toxicity

Featured Editorial
Industry Insights
eCOA/ePRO: Why Patients Deserve Even More Progress

The shift from reporting on paper to reporting electronically has been happening for years; however, the transition hasn’t always been elegant. Explore how the pandemic has played a role in accelerating the shift to eCOA/ePRO.

Exploring Integrations In Decentralized Clinical Trials

In the available blog, see how each decentralized clinical trial is unique and has its own set of requirements and may require integrations between systems.

Intelligent Automation For The Trial Master File With AI-Driven Applications

Explore an example of an in-production capability enhanced by artificial intelligence and used by over 6,000 employees across the globe in multiple languages today.

Reimagine Clinical Trials With Open Approaches And Interoperability

Discover the reason why old data collection systems can inhibit fully leveraging the insights derived from that data that has been collected.

Beyond First Impressions: CTIS Lessons Learned In First Three Months

Now that the EU’s Clinical Trials Information System (CTIS) is up and running, disclosure and transparency experts from Sarepta, Boehringer Ingelheim, Bayer, and Merck KgaA discuss the ins and outs of registering clinical trials and submitting study information to the portal.

Building Empathetic Clinical Trial Recruitment Programs

Effective and efficient clinical trial recruitment remains a fundamental challenge for ultimate study success. Possible solutions with the most potential to finally crack the code on improving study recruitment lie in the simple need to consider and care about the experiences of those involved.

Featured Editorial
Industry Insights
Enriching Oncology Studies With RWD Before, During, And After The Trial

In this webinar, experts discuss how enriching oncology clinical trials with RWD generates deeper insights and improves operational efficiency to achieve better patient outcomes.

Setting A Strong Foundation For Late-Stage Development

After Phase 1 and into Phase 2 trials, it's time to identify the quickest scale-up path for supplying efficacy trials and commercial demands while keeping the formulation as simple as possible.

The Decentralized Clinical Trials Continuum

The clinical trial landscape is continually adapting its focus on patient-centric practices to improve clinical trial participation by reducing patients’ burden. By leveraging virtual trial tools and strategies, you can support a patient-centric approach and continue to deliver efficient and superior quality clinical trials.

Integrating Early-Phase Development Clinical Supply Manufacturing And Distribution

A tablet formulation was a solution when developing a new class of anti-infective medicine, allowing the integration of formulation development, clinical trial material (CTM) manufacturing, and supply and distribution to patients.

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.

A Technology Foundation For Decentralized Clinical Trials And CRO Operations

As the majority of patients and care providers appear to be satisfied with the quality of telemedicine and digitally facilitated appointments, learn why it’s likely that decentralized trials will be part of the operating standard for CROs.

Clinical Leader Live
Industry Insights
How To Optimize Adherence Of Wearables In Your Clinical Research

Learn about the top three factors to consider when working to maximize protocol adherence and minimize missing data in a technology-enabled clinical trial.

Regulatory, Cost Implications Of Switching Injectable Delivery Formats

Launching a large molecule in one format and then switching the delivery format often transpires as a lifecycle management strategy for cost efficiency, supply chain continuity, and patient benefit. 

Taking The Complexity Out Of Rare Disease Trials For Small To Midsize Biotech Sponsors

Clinical trials in rare diseases can be difficult to run due to a lack of patients, complicated study designs, and challenging logistics; all of the above imply involvement of numerous countries, many sites, and lengthy timelines to completion. However, when you have the required expertise, studies in rare diseases are collaborative, innovative, and rewarding. 

Gap Analysis: How Objective Review Benefits Biopharma Clinical Quality Systems

A comprehensive gap analysis examines documented procedures, SOPs, and QMS processes, but also includes discussions with key personnel and scrutinizes outputs derived from those SOPs and processes. Learn about the “report card” — an independent key deliverable that helps the organization identify, prioritize, and remediate potentially problematic areas.

Bringing Patient Centricity And Scale To Decentralized Trials

In the available webinar, explore how DCTs have forced the industry to rethink their approach to study start-up and associated regulations.

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