The clinical trials industry is compelled to embrace digital transformation in its approach to patient recruitment and engagement, study design protocols, and overall trial management. But what's the crucial component to ensure its success? Global standards that help cultivate trust.
- How To Make Trials More Successful With Medical Monitors
- LATAM’s Regulatory Framework For Medtech Early Feasibility Studies
- Needed: An AI Revolution In The Rare Disease Space
- How — And Why — To Embrace Intersectionality In Clinical Trials
- Tips To Overcome The 4 Major Barriers To Patient Diversity
- Survey Reveals High Levels Of CTIS Adoption In Europe
- India’s New Drugs, Medical Devices, And Cosmetics Draft Bill 2022
GUEST COLUMNISTS
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![Female-doctor-at-office-GettyImages-1367408214]( "Key Learnings To Optimize Clinical Trials During COVID-19")
Key Learnings To Optimize Clinical Trials During COVID-19Designing and conducting trials during the COVID-19 global pandemic forced clinical teams to be creative, to explore the use of technology, and to design a trial that meets the participants where they are — without compromising outcomes.
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![Idea-GettyImages-1364280438]( "Key Insights From The 2022 PDA/FDA Joint Regulatory Conference")
Key Insights From The 2022 PDA/FDA Joint Regulatory ConferenceKey focus of this article is spent on thoughts shared by the FDA speakers, including the importance of a quality infrastructure, sustainable compliance, data integrity, and more.
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![GettyImages-1321906152]( "How To Implement Patient-Focused COAs")
How To Implement Patient-Focused COAsDrug developers often talk about “patient centricity,” but most find it challenging to prioritize a patient-centric research approach in the earlier phases of drug development. A good place to start is by collectively measuring what matters most to patients — and COAs help get us there.
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![Speech-Bubbles-GettyImages-1370624040]( "How To Optimize Returns On Plain Language Summaries")
How To Optimize Returns On Plain Language SummariesThe EMA now requires Plain Language Summaries (PLS) for clinical trials with sites in the EU. The FDA has no current regulations for PLS, but they fit into recent guidance documents. PLS meet the needs of trial participants, their families, and patient advocacy groups, among others. Optimize your PLS with these tips.
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![GettyImages-1199119631]( "RWE & Advanced Diagnostics Propel Better Patient Outcomes")
RWE & Advanced Diagnostics Propel Better Patient OutcomesNotable diagnostic advancements in data science and the scientific community’s ability to use analytic tools are playing an essential role in improving patient outcomes.
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![FDA headquarter iStock-1213293784]( "FDA Releases Final Guidance On RWD/RWE Submissions For Drugs & Biologics")
FDA Releases Final Guidance On RWD/RWE Submissions For Drugs & BiologicsThe guidance describes the approach sponsors should use to identify if and how real-world data (RWD) and real-world evidence (RWE) are incorporated into their regulatory submissions. The FDA notes that this guidance specifically applies to INDs, NDAs, and BLAs that contain RWD and RWE.
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![Substance-abuse-GettyImages-856185810]( "Search For Similarity: Regulatory Considerations Of Drug Abuse Potential Investigations")
Search For Similarity: Regulatory Considerations Of Drug Abuse Potential InvestigationsThis article focuses on FDA and EMA regulatory guidelines surrounding drug abuse/dependence and abuse potential investigations, particularly in animal studies. Discussion includes penetration of the blood-brain barrier, structural similarity screening, and investigation of pharmacological similarity.
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![Doctor-patient-GettyImages-1345513639]( "5 Ways To Expand Racial & Ethnic Diversity In Clinical Trials")
5 Ways To Expand Racial & Ethnic Diversity In Clinical TrialsBetween 2000 and 2020, nearly 80% of clinical trial participants were white. The underrepresentation of diverse racial and ethnic groups is not new, but we must do more to address disparities. Here are five strategies for action.
CLINICAL TRIAL WHITE PAPERS
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![gettyimages-1330728769-170667a]( "Advancing Drug Development Using In Silico Modeling")
Advancing Drug Development Using In Silico ModelingLearn how in silico modeling can improve the likelihood of clinical success and return on investment for investigational new drug development.
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The Importance Of Decentralized Clinical Trials7/27/2021
While the standards and value of clinical trials remain high, new implementation techniques have allowed for the adoption of decentralized clinical trials. Download the available white paper to find out more.
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Patient Centricity And Virtualizing Technologies In A COVID-19 World1/29/2021
As the COVID-19 pandemic rages on, clinical trial conduct is being reimagined in ways few thought possible not so long ago. Patient centricity is a growing and important movement within clinical trials. New information is constantly filtering in as to how sites are adapting to the COVID-19 era, and how patient-centric solutions are playing a growing role. The Society for Clinical Research Sites (SCRS) recently collaborated with Medidata (a Dassault Systemes Company) to conduct an online survey to measure current and anticipated levels of adoption of patient-centric tools, and the sites’ perspective on how patients have reacted to them.
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Guide To Digital Endpoints In Rheumatology Research11/14/2022
In rheumatology, learn why both the FDA and EMA have highlighted the need to assess physical function and walking as key efficacy endpoints.
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Phlexglobal Innovation Tour 2020: Industry Survey Results & Expert Analysis1/25/2021
On July 15, 2020, we launched the Phlexglobal Innovation Tour to bring together experts from across our industry to discuss clinical and regulatory related topics and explore innovative approaches to making compliance faster, easier, and better. What follows are the results of focused audience polls done during each session and afterwards together with the thoughts of our Innovation Tour experts
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The Future Of Health Data: A 2022 Life Sciences Industry Insights Report11/14/2022
A survey of life sciences leaders reveals some of the key challenges that come with using real-world data (RWD) for innovation, along with their vision and predictions for how RWD can accelerate drug development and improve patient outcomes.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Ora Streamlines Clinical Trials With Veeva Vault CTMS And BA Insight AppBus Platform2/16/2021
Ora, a full-service contract research organization specializing in ophthalmology, aims to accelerate development timelines for its sponsor clients, so productivity and efficiency are critical to delivering high-quality engagements. To achieve its goal of providing best-in-class clinical services, Ora easily integrates Vault CTMS with other applications using the BA Insight AppBus low-code platform.
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How Workflow Software Can Shift Space And Time6/29/2021
Workflow software has the power to literally shift space and time. In this article we share some examples of how software can expand access for any process and describe specific applications and benefits for clinical research.
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Study Start-Up And Enrollment7/27/2021
IQVIA Biotech was approached by a clinical-stage biopharmaceutical company to run its Phase II prostate cancer drug trial in the U.S. For more information, download the available case study.
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Preparing For The Next Pandemic: Lessons Learned8/18/2021
COVID-19 impacted how clinical trials are conducted and emphasized the need to stay ahead of emerging viruses and diseases. Explore insights on which measures and approaches will most likely continue to be implemented in the future.
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Decentralized Trials For Duchenne Muscular Dystrophy9/21/2021
Working closely with a global biotechnology company on a mission to engineer precision genetic medicine for rare diseases, MRN has delivered more than 180 home visits per month to keep trials running across a vulnerable, pediatric population during the COVID-19 pandemic.
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Simulation-Based Training For Better Decisions10/5/2021
Learning through simulation has historically been reserved for industries where even the smallest errors have major consequences. Clinical research is late to the party, only now realizing that the consequences of poorly trained staff, ranging from protocol deviations to site failures, can be avoided.
NEWSLETTER ARCHIVE
- 11.23.22 -- Help Your Sites Manage Training & Education On DCTs
- 11.23.22 -- From eTMF To Decentralized Trial Solutions - Clinical Trial Software And Services
- 11.22.22 -- How To Implement An EMDS For Virtual & Early Stage Pharma
- 11.22.22 -- Clinical Supply Planning For Studies With Unconventional Timelines
- 11.21.22 -- Sanofi Reshapes Patient Experience With Digital Technologies
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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![GettyImages-1321906152]( "How To Implement Patient-Focused COAs")
Drug developers often talk about “patient centricity,” but most find it challenging to prioritize a patient-centric research approach in the earlier phases of drug development. A good place to start is by collectively measuring what matters most to patients — and COAs help get us there.
-
![Speech-Bubbles-GettyImages-1370624040]( "How To Optimize Returns On Plain Language Summaries")
The EMA now requires Plain Language Summaries (PLS) for clinical trials with sites in the EU. The FDA has no current regulations for PLS, but they fit into recent guidance documents. PLS meet the needs of trial participants, their families, and patient advocacy groups, among others. Optimize your PLS with these tips.
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![Doctor-patient-GettyImages-1345513639]( "5 Ways To Expand Racial & Ethnic Diversity In Clinical Trials")
Between 2000 and 2020, nearly 80% of clinical trial participants were white. The underrepresentation of diverse racial and ethnic groups is not new, but we must do more to address disparities. Here are five strategies for action.
EMBRACING DIVERSITY & INCLUSION
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![GettyImages-511457590]( "LATAM’s Regulatory Framework For Medtech Early Feasibility Studies")
Latin America is a compelling region to conduct medtech early feasibility studies due to its ethnically diverse population, its high rate of urbanization, and more. Here, the author spotlights Colombia, Brazil, and Mexico as the hotspots for medtech feasibility studies in Latin America.
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![Senoir-Couple-Homecare-Visit-GettyImages-1375404465]( "How — And Why — To Embrace Intersectionality In Clinical Trials")
Intersectionality is the framework for how a person’s relationships, identities, interactions, and interdependencies can create different advantages and disadvantages. In order to fully embrace intersectionality and make meaningful impacts in clinical trial recruitment of diverse populations, the entire journey of the patient must be realized — every step of the way.
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![Doctor-patient-GettyImages-1345513639]( "5 Ways To Expand Racial & Ethnic Diversity In Clinical Trials")
Between 2000 and 2020, nearly 80% of clinical trial participants were white. The underrepresentation of diverse racial and ethnic groups is not new, but we must do more to address disparities. Here are five strategies for action.
