Sponsors need to proactively identify and manage the risks involved with working with a CRO. This kind of oversight can help reduce the likelihood of negative consequences that could impact the quality of a trial.
- Diversity In Clinical Research Execution And Participation
- RWD/RWE: To Replicate Or Continue To Learn In The Real World?
- Why Russia's Invasion Of Ukraine Threatens Our Life Science Ecosystem
- Decentralized Clinical Trials: Key Considerations For Sites & PIs
- Takeda Takes A Strategic Approach To TMF
- How To Navigate Drug Repurposing And Bridging Studies
- How To Build A Strong CRO Partnership And Find Drug Development Success
GUEST COLUMNISTS
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How To Navigate Drug Repurposing And Bridging Studies
Rarely is a new drug the optimal version of that product, and drug companies often search for new uses, new users, or new dosage forms of an approved product after it hits the market in what is commonly known as “drug repurposing.” To receive FDA approval for a repurposed drug, companies must submit bridging studies that often include clinical trials.
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How To Build A Strong CRO Partnership And Find Drug Development Success
Building a collaborative and highly engaged partnership with a CRO to optimize study enrollment is critical for a company’s success, particularly with so much reliance on virtual interactions. Here are some tips on how to do just that.
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Clinical Trial Duration Trends & The Study Closeout Gap
Clinical study durations are increasing. Contributing significantly is what we will refer to as a study closeout gap. Is your company positioned to reverse this trend and reduce time to market for your new drugs and therapies? This article explores study duration data as well as related labor challenges and macroeconomic trends.
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How To Leverage RWE To Facilitate Access To Cell & Gene Therapies
As more and more cell and gene therapies hit the market, the already intense pressure to figure out how to pay for them will only increase. This article shares how real-world evidence (RWE) can be leveraged to help offset economic uncertainties, facilitate access, and create a sustainable foundation for long-term data generation.
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Improving Diversity In Clinical Trials With A Community-Based Approach
Executives of clinical trial sponsors and CROs must acknowledge that the current system fosters inequities such as decreased access and poorer healthcare outcomes for historically underserved patient populations. By committing to a community-based approach to enhance clinical trial diversity, we can further enable improved healthcare outcomes for all.
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Latin America: A Compelling Region To Conduct Your Clinical Trials
This article examines the need to conduct clinical trials outside the U.S., addresses the recruitment crisis in the U.S., reviews the incentives for clinical trials overseas, and explores the growth of clinical trials in Latin America. Colombia is highlighted as a country that stands out as ripe with opportunity.
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IVDR Compliance: You May Need To Rethink Your Clinical Evidence Strategy
European notified body feedback reveals that the biggest gaps in In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) submissions are being found in clinical evidence, particularly around clinical performance data. Also covered in this article is discussion of overlap between EU and FDA requirements.
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How Can We Investigate Biomarkers For Lung Cancer Patients More Effectively?
With a 5-year mortality rate of nearly 90%, lung cancer is in dire need of targeted control interventions. There is a serious lack of sufficient predictive biomarkers, turning the lung cancer journey into one in which the patient and physician alike may as well be wearing blindfolds. This article discusses how we can start to swing the needle in the patient's favor.
CLINICAL TRIAL WHITE PAPERS
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Continuous Manufacturing And Late-Phase Strategy: The Time Is Now
Explore recent progress in continuous manufacturing and guidance for answering key questions related to implementation of continuous processing for late-phase development.
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Tips For Tailoring eConsent For Optimal Patient Centricity3/29/2022
While informed consent is a critical process for ensuring participant autonomy, consent forms are too long, unclear, difficult to read, and frequently exceed 9th grade reading levels. Explore why eConsent is a potential solution to this problem.
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Breaking The Mold In Clinical Systems Integrations1/18/2022
There is a plethora of data points needed to run a successful trial through to approval. Departments (drug supply, clinical, finance) may have different uses for the same data, and therefore the way they track and communicate the data varies. Learn how this all varies in this white paper.
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Expanded Access And Commercial Packaging Strategies For Orphan, Niche, And Low-Volume Drugs7/20/2020
Most commercial contract drug packagers do not provide consistent scheduling for low-volume drugs, which could lead to delays that create a market shortage that triggers serious health consequences for patients. A clinical supply partner can provide packaging as needed and handle distribution for expanded access and general commercial needs.
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Report: Impacts Of Decentralized Clinical Trials 20218/10/2021
Decentralized clinical trials have had the potential to revolutionize studies for a number of years, though in the last two years, accelerated by COVID-19, they have finally started to realize some of that potential. This final report based on 125 responses reveals unique insights into the adoption of decentralized trials today.
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FDA Designations for Rare Disease Products: A Complete Guide8/27/2021
This paper highlights the designation programs available specifically for products with rare disease indications: Orphan Drug Designation (ODD), Rare Pediatric Disease Designation (RPDD), and Humanitarian Use Device (HUD) designation. Explore the criteria, timeline and maintenance, and benefits of each designation.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Diversity In Clinical Research: Improving Clinical Trial Representation With High-Quality Training10/27/2021
Over the last several years, the pharma industry has become increasingly focused on issues of diversity. This has been reflected in regulatory guidelines and in the clinical trial recruitment phase of new drug research and development. However, relatively little attention has gone to diversity within the clinical research workforce, which many industry insiders have suggested can significantly enhance study population diversity.
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eTMF Implementation Quick Guide1/21/2021
Implementing an eTMF for the first time can feel like a daunting process. This checklist will help you focus on some primary considerations to reduce risks, maintain compliance, and establish effective processes in your eTMF so that your team embodies a culture of inspection readiness from the start.
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Elevating Effective Outcomes With Companion Diagnostics3/22/2021
Companion diagnostics (CDx) is a keystone for pharma to create more precise drug therapies as personalized medicine accelerates. Here’s why a CDxcentral laboratory partner is necessary.
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Large Research Healthcare System Maintains Compliance Through Internal Program Assessment6/28/2022
Explore how a clinical research operations assessment was conducted to ensure compliance and maintain critical funding sources.
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High-Quality, Audit-Ready Clinical Research Driven By Digital Data Management8/3/2020
A contract research organization (CRO) focused on quality needed to more thoroughly document clinical studies for sponsors, regulatory authorities and other auditors. With a cloud-based, unified IBM® Clinical Development platform, the CRO can now quickly create accurate digital records of every action taken, including granting users access and updating study protocols.
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Real-World Evidence In Clinical Trials8/11/2021
Recent technological innovations have expanded the potential for the collection of real-world evidence (RWE) in clinical trials. Read how t hrough patients’ personal devices, fixed in-home sensors, or third-party wearable devices (e.g., Fitbit) and biological sensors, researchers can now collect ecologically valid data representing a wide array of constructs.
NEWSLETTER ARCHIVE
- 06.29.22 -- What Should You Look For In A CRO Partner?
- 06.29.22 -- Clinical Supply Optimization And Comparator Local Sourcing Strategies
- 06.28.22 -- Overcoming Patient Recruitment And Retention Challenges In Rare Disease Studies
- 06.28.22 -- The Steps To Executing Gene Therapy Trials
- 06.27.22 -- SCRS Puts A Spotlight On Diversity
COVID-19 AND YOUR CLINICAL TRIALS
- UCB Uses Decentralized Trials To Manage Studies
- #NoGoingBack Supports Keeping Patients First
- X4 Pharma Adjusts Clinical Trials For A COVID World
- Lilly, Care Access Take COVID Trial Directly To Patients
- From Idea To Patient In 10 Weeks: NeuroRx’s Fast Track Approach
- 3 Steps To Get A Virtual Clinical Trial Up And Running
- Can Virtual Trials Maintain Their Momentum After COVID?
CLINICAL LEADER CONTENT COLLECTIONS

The articles in this e-book all relate to the challenge of CRO selection. We hope you enjoy them and learn from the insights contained in them.
More Content CollectionsFOCUS ON PATIENTS
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In this article we compare the 2020 and 2021 result of the WCG Avoca Industry Survey, which explores industry respondents’ views on patient diversity in clinical research participation.
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Executives of clinical trial sponsors and CROs must acknowledge that the current system fosters inequities such as decreased access and poorer healthcare outcomes for historically underserved patient populations. By committing to a community-based approach to enhance clinical trial diversity, we can further enable improved healthcare outcomes for all.
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For rare disease clinical trials, communications are enabled by working closely and effectively with patient advocacy organizations. In this article, a director of scientific and patient affairs shares 4 tips on what has helped their company overcome some of the barriers.
EMBRACING DIVERSITY & INCLUSION
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We are at the beginning of important conversations. Conversations that need to happen so we can definitively address the health disparities that continue to impact outcomes among ethnic and racial groups in the United States.
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Advancements of the protocols, tools, and technologies that were highly leveraged during the COVID-19 pandemic are the key to breaking down the barriers that perpetuate clinical trial disparities.
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To achieve better outcomes and health equity for historically underserved populations, we must address the not widely acknowledged, hidden, real-world reasons for such poor diversity in clinical trials. Here, we will pull back the covers on the issues we must tackle to improve diversity in trials.