Newsletter | November 30, 2022

11.30.22 -- Unexpected Results: What I Learned During 12 Site Audits In Africa


Welcome to the Wednesday edition of the Clinical Leader newsletter, focusing on Decentralized Trials and Trial ManagementUpdate your topic preferences to receive additional Clinical Leader newsletters on:

  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)
Webinar: Optimizing Clinical Supply Chain Management

The complexity of today’s clinical trials creates logistical challenges for clinical operations teams that result in a variety of problems. In this webinar, clinical operations teams, project managers, and clinical research coordinators will learn best practices to optimize clinical supply chain management. Click here to learn more.

Trial Management
A Firsthand Experience In Africa: Better Than Expected

Except for South Africa, sub-Saharan African countries are still largely underrepresented in the global clinical study map. Hesitation to conduct clinical studies in Africa may be partly a result of assumed poor infrastructure, missing regulations, and inexperienced researchers. But is it truly so? Or is our thinking stuck somewhere in the past?

The Asia-Pacific Region’s Growing Role In Oncology Trials

This webinar examines the advantages of conducting trials in this fast-growing region and delves into other issues sponsors should consider when choosing sites for upcoming trials.

Six Trends Shaping Tomorrow's Clinical Trials

Due to the continuous growth in drug development costs, there has never been a greater need for new and innovative ways to support the clinical trial supply chain. Explore key trends that are pushing the innovation envelope.

Innovative, Patient-Centered Approaches For Gene Therapies

Find out how long-term follow-up (LTFU) studies for gene therapies present unique challenges and highlight important considerations for different kinds of sponsors, including biotech and emerging biopharma.

Clinical Trials From Home: The Role Of Research Nurses

Learn about the advantages of home visits for clinical trials and what research nurses do to make this possible.

Reimagining The Critical Path Through Supply Chain Innovation

In today’s unpredictable clinical landscape, read about complex challenges and innovative strategies to safely deliver lifesaving advanced treatments to patients.

Hitting The Target With Good Study Design

This Q&A discusses the benefits of good study design for sponsors and sites, the downstream effects of standardized study designs, and the tips for designing it on your own.

The Surprising Path To The Future Of Diagnostic Clinical Trials

Discover how the increase in demand for early detection and diagnostic modalities promotes a proactive versus reactive approach to medicine — something that can drive improved patient outcomes.

The Ultimate Guide: Scenario Planning Clinical Supply Decisions

Explore how scenario planning enables you to find the best strategy while balancing risks and costs and gives you the ability to arm your internal stakeholders with impact assessment data based on plausible scenarios.

Imaging In Clinical Trials: Pitfalls And Promises

In this webinar, attendees will learn how experts apply imaging science and operational expertise to identify and manage the inherent risks when capturing complete and high-quality central review data of study endpoints.

Optimizing IRT For Clinical Supply Management

Experts speak on supply capabilities within interactive response technology (IRT) and how flexibility is important to functionality, who to involve, and which questions to ask in optimizing IRT for clinical supply.

Solara™ Software For Optimizing Clinical Trial Design

Solara enables exponentially larger exploration of the study design space. This patent-pending, collaborative, decision-support platform reveals innovative opportunities to shorten trial duration, increase power, and reduce cost.

Helping Move Rare Disease Research Forward

Our work spans all aspects of clinical trials and drug development, encompassing more than 190 rare disease studies across multiple indications in the past five years with seven successful drug approvals and three Breakthrough designations.

Webinar: The Future Of Clinical Data Management Part 3 — The Evolution Of Data Capture And Its Impact On Clinical Data Management

Join Part 3 of our webinar series to learn how the evolution of data collection innovation is impacting clinical data management. You’ll discover new skills, techniques, and technologies that are required to review, clean, lock, and transform data for analysis and submission. Click here to learn more.

Decentralized Trials
Trends To Watch: RWD, DCTs, And Cell And Gene Trials

At this time of year, I receive numerous emails from companies outlining predictions for the coming year from some of their executives. Here are a few I'd like to share, based on emails I received from Mobiquity, Veeva, 4G Clinical, Cognizant, and others who were kind enough to share their insights.

Clinical Trial Modernization: Optimizing The Supply Of DCTs

Clinical sites and sponsors have had to quickly implement solutions, and biopharma companies are heeding the call to innovate, be agile, reduce waste, and, most of all, achieve patient centricity.

How Targeted Data Verification Reduces Risk In DCTs

Gain insight into how a combination of consulting and technology enabled a CRO to reduce the time and cost of a clinical study so that the team could take quick action to reduce risk and improve patient safety.

Collect Better Oncology Trial Data, Easier

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

Improving Patient And Sponsor Confidence In Decentralized Clinical Trials

During this webinar, speakers will debunk common myths associated with novel approaches to data collection using technology and highlight strategies to improve the patient experience, without compromising quality, speed, or cost.

Key Considerations For Drug Sponsors Conducting DCTs And Hybrid Trials

Read this webinar presentation as panelists share lessons learned and recommendations for designing protocols that enable flexibility in your virtual trials’ conduct.

The Future Of Digital Trials: On The Floor At DIA

Watch this video to learn what steps the industry can take to remove the technology burden on clinical research sites.

What Universal Alignment Of Industry Terminology Means For DCTs
Many DCT stakeholders have attempted to release terminology guides as relates to their own dealings; however, there had never been a wide range of universalized DCT terms until now.