Beyond the Ordinary Beyond the Obvious
Credit: Dr_Microbe | stock.adobe.com Updated data from the final analysis of the Phase III TALAPRO-2 trial (NCT03395197) show…
Image Credit: © WESTOCK – stock.adobe.com The clinical research industry finds itself at a crossroads, faced with difficult…
Credit: Juan Gärtner | stock.adobe.com Results of the multinational Phase II eNRGy trial (NCT02912949) show that zenocutuzumab (Bizengri)…
Mike Hennessy Jr, president and CEO, MJH Life Sciences® Whenever the calendar shifts to a new year, I…
Applied Clinical Trials February 2025 Issue (PDF) Central Monitoring is Uncovering Emerging Quality Risks in Clinical Trials Replacing…
Image Credit: © Murrstock – stock.adobe.com Central monitoring, a practice recommended by the FDA over 11 years ago,…
Credit: Matthieu | stock.adobe.com The latest findings released from the Phase III EV-302/KEYNOTE-A39 (NCT04223856) trial show that the…
Melissa Hutchens, Vice President, Research & Benchmarking, WCG As clinical trial complexity, duration, and cost continue to rise,…
Beth Harper, MBA,Project Manager, Senior Research Consultant Zachary Smith,Assistant Director, Data Sciences and Analytics Ruby Madison Ford, Research…
ACT: What are CluePoints’ key objectives for participating in SCOPE 2025, and how do you see the conference…
ACT: What advice do you have for small biopharma companies looking to scale their clinical programs without overextending…
In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops…
Reliable data is critical for making informed decisions about the efficacy and safety of new treatments in clinical…
Hugo Stephenson, MD, Co-Founder and Executive Chair, TrialScreen In clinical trials, every conversation with a patient carries weight,…
Brian S. McGowan, PhD, FACEHP, Chief Learning Officer and Co-Founder, ArcheMedX, Inc. I was recently invited to deliver…
ACT: Can you share a few examples of how artificial intelligence/machine learning (AI/ML) can mitigate risks that have…
ACT: What are the biggest risks small biopharma companies face when partnering on clinical trials, and how can…
ACT: What are some of your key takeaways from the panel you participated in on pragmatic trials? Garty:…
ACT: Could you share your thoughts on the recent findings from Tufts CSDD’s PACT Consortium linking the use…
ACT: Today, you were a part of the Choosing the Right Allies: Ensuring Clinical Trial Success for Small…
Image Credit: Andy Studna The opening keynote panel on day 1 of SCOPE (Summit for Clinical Operations Executives)…
This year’s SCOPE conference in Orlando kicked off with a keynote address from Janice Chang, CEO, TransCelerate Biopharma,…
Credit: Rasi | stock.adobe.com Updated topline data from the Phase III BREAKWATER trial (NCT0460742) show the combination of…
In a recent video interview with Applied Clinical Trials, Michael Andreini, president and CEO of the Multiple Myeloma…
In a recent video interview with Applied Clinical Trials, Michael Andreini, president and CEO of the Multiple Myeloma…
The promise of modern clinical trials is often hindered by a hidden burden: technology that fails to address…
In a recent video interview with Applied Clinical Trials, Michael Andreini, president and CEO of the Multiple Myeloma…
Image Credit: © Crystal light – stock.adobe.com Kazia Therapeutics has announced the regulatory approval and launch of its…
Credit: chalani | stock.adobe.com Findings from a 12-month open-label extension (OLE) of the Phase Ib/IIa PACIFIC trial demonstrated…
Image credit: © putilov_denis – stock.adobe.com Clinical research is critical to discovering life-changing therapies for patients, especially in…
Credit: samunella | stock.adobe.com Merck has announced an early end to the Phase III HYPERION trial (NCT04811092) evaluating…
Image credit: © FlowStudio – stock.adobe.com Medable has shared new data from the Tufts Center for the Study…
Credit: Sebastian Kaulitzki | stock.adobe.com Updated findings from the Phase III INAVO120 trial (NCT04191499) show that the combination…
Image credit: luchschenF | stock.adobe.com Roche has announced positive results from the Phase III EMBARK clinical trial of…
In a recent video interview with Applied Clinical Trials, Michael Andreini, president and CEO of the Multiple Myeloma…
Image Credit: © Sebastian Kaulitzki – stock.adobe.com Pfizer has announced positive results from the Phase III BREAKWATER clinical…
In a recent video interview with Applied Clinical Trials, Dipanwita Das, CEO & co-founder at Sorcero, discussed advancements…
Credit: photon_photo | stock.adobe.com A new analysis published by JAMA Network Open identified room for improvement in the…
Credit: JYPIX | stock.adobe.com Findings from a Phase I pharmacokinetic (PK) trial show the promise of a decentralized…
Credit: Andrii | stock.adobe.com Data from the Phase III Vivacity-MG3 trial (NCT04951622) show the investigational therapy nipocalimab improved…
Credit: David A Litman | stock.adobe.com New data released from the Phase III LEAP-015 trial (NCT04662710) show that…
Image Credit: © lidiia – stock.adobe.com Medidata announced it has extended its 13-year partnership with Tigermed, a provider…
In a recent video interview with Applied Clinical Trials, Dipanwita Das, CEO & co-founder at Sorcero, discussed advancements…
Image Credit: © iDoPixBox – stock.adobe.com Genprex announced that the first patient has been enrolled and dosed in…
In a recent video interview with Applied Clinical Trials, Dipanwita Das, CEO & co-founder at Sorcero, discussed advancements…
Image Credit: © ipopba – stock.adobe.com Advarra has unveiled its Study Collaboration solution, a new offering designed to…
In a recent video interview with Applied Clinical Trials, Dipanwita Das, CEO & co-founder at Sorcero, discussed advancements…
Image Credit: © Egor – stock.adobe.com Digital transformation was a common theme at conferences like World Drug Safety…
In a recent video interview with Applied Clinical Trials, Dipanwita Das, CEO & co-founder at Sorcero, discussed advancements…
Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical…
In a recent video interview with Applied Clinical Trials, Kimberly Tableman, founder & CEO, ESPERO, discussed the challenges…
Credit: SOMKID | stock.adobe.com The results of a pilot trial (UMIN000049251) published by JAMA Network Open showed the…
In a recent video interview with Applied Clinical Trials, Kimberly Tableman, founder & CEO, ESPERO, discussed the challenges…
Credit: LASZLO | stock.adobe.com An updated prespecified final analysis of the Phase III KATHERINE trial (NCT01772472) found that…
Credit: 9dreamstudio | stock.adobe.com Topline findings from the 72-week STEP UP trial (NCT05646706) show that semaglutide at a…
Image Credit: © Dr_Microbe – stock.adobe.com The FDA has approved AstraZeneca’s Calquence (acalabrutinib), in combination with bendamustine and…
In a recent video interview with Applied Clinical Trials, Kimberly Tableman, founder & CEO, ESPERO, discussed the challenges…
Image Credit: © Sebastian Kaulitzki – stock.adobe.com The FDA has approved Eli Lilly’s Omvoh (mirikizumab-mrkz) for the treatment…
In a recent video interview with Applied Clinical Trials, Kimberly Tableman, founder & CEO, ESPERO, discussed the challenges…
Image Credit: © photon_photo – stock.adobe.com With drug development processes increasing in complexity, companies are working to drive…
Image Credit: © lidiia – stock.adobe.com Suvoda and Greenphire have announced an agreement to merge. The merger will…
Credit: YURII MASLAK | stock.adobe.com Decentralized clinical trials (DCTs) involve some or all trial-related activities conducted at locations…
Image Credit: © Jakub Krechowicz – stock.adobe.com Depending on who you ask, opinions on the state of diversity,…
Credit: Dr_Microbe | stock.adobe.com Positive efficacy and safety findings from the TROPION-Lung05 (NCT04484142) and TROPION-Lung01 (NCT04656652) clinical trials…
Image Credit: Adobe Stock Images/Nvisions On June 26, 2024, the FDA released updated guidelines for diversity, equity, and…
In a recent video interview with Applied Clinical Trials, Sujay Jadhav, CEO of Verana Health, discussed potential advancements…
Credit: alexlmx | stock.adobe.com New research using the characteristics of clinical trials to project the cost of developing…
Credit: Saiful52 | stock.adobe.com The results of a Phase Ib/II dose escalation and expansion trial (NCT04586426) found that…
Credit: LASZLO | stock.adobe.com Results of the Phase III IRAKLIA trial (NCT05405166) found that a subcutaneous (SC) version…
Image Credit: © Kaikoro – stock.adobe.com A new study led by Winship Cancer Institute of Emory University and…
In a recent video interview with Applied Clinical Trials, Sujay Jadhav, CEO of Verana Health, discussed potential advancements…
Image Credit: Adobe Stock Images/Lila Patel The FDA has granted priority review to Johnson & Johnson’s nipocalimab for…
In a recent video interview with Applied Clinical Trials, Sujay Jadhav, CEO of Verana Health, discussed potential advancements…
Image Credit: © Dr_Microbe – stock.adobe.com The FDA has granted Fast Track designation to Marengo Therapeutics’ invikafusp alfa…
Credit: Crystal light | stock.adobe.com Topline results from the Phase III MARIPOSA trial (NCT04487080) show the combination of…
Image Credit: © Kaikoro – stock.adobe.com Over the past two years, generative artificial intelligence (AI) has emerged as…
In a recent video interview with Applied Clinical Trials, Sujay Jadhav, CEO of Verana Health, discussed potential advancements…
Image Credit: © JHVEPhoto – stock.adobe.com The FDA announced it has issued a new draft guidance on the…
Credit: Halfpoint | stock.adobe.com A new study published by JAMA Dermatology illustrates the significant impact of cutaneous chronic…
The annual SCOPE (Summit for Clinical Operations Executives) conference has revealed the six finalists for its 9th Annual…
Image Credit: © Rochu_2008 – stock.adobe.com Novartis has announced positive results from the Phase III STEER clinical trial…
Elizabeth Hickman, Chief Business Officer, AustinPx Throughout my career as a chief business officer and strategy executive, I…
Credit: Vitalii Vodolazskyi | stock.adobe.com Findings from a Phase III trial (NCT04124614) published by JAMA Psychiatry demonstrated that…
In a recent interview with Applied Clinical Trials, Rachael Fones, director, government & public affairs, IQVIA, discussed the…
Image Credit: © Andrii Yalanskyi – stock.adobe.com Translating medical documents between English and German requires more than just…
October 16th 2024 Podcast Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and…
Credit: Saiful52 | stock.adobe.com Detailed results from an interim analysis of the Phase III DREAMM-7 trial (NCT04246047) demonstrated…
The top five episodes of our podcast in the year 2024, highlighted.
Image Credit: © Radomir Jovanovic – stock.adobe.com In recent years, antibody-drug conjugates (ADCs) have dominated the oncology space,…
Beth Anderson, CEO, Arkitek Scientific Success! The drug you developed has made it to the marketplace, and is…
Image Credit: © Tierney – stock.adobe.com In the current clinical trial landscape, sponsors and contract research organizations (CROs)…
Image Credit: © NicoElNino – stock.adobe.com The pharmacovigilance (PV) regulatory landscape is continually evolving, driven by the effects…
Image Credit: © peshkova – stock.adobe.com Below is a list of the most viewed video interviews from Applied…
In a recent interview with Applied Clinical Trials, Rachael Fones, director, government & public affairs, IQVIA, discussed the…
In a recent interview with Applied Clinical Trials, Rachael Fones, director, government & public affairs, IQVIA, discussed the…
Credit: Mopic | stock.adobe.com The novel agent imlunestrant, administered both as a monotherapy and in combination with Verzenio…
In a recent video interview with Applied Clinical Trials, Jane Myles, program director, Decentralized Trials & Research Alliance…
Credit: Sebastian Kaulitzki | stock.adobe.com The results of the SWIFT-1 (NCT04719832) and SWIFT-2 (NCT04718103) trials demonstrated that depemokimab…
Credit: wladimir1804 | stock.adobe.com The investigational monoclonal antibody prasinezumab (Roche; Prothena) fell short of achieving statistical significance for…
In this upcoming roundtable discussion, panelists will discuss the role of eCOA and eConsent in clinical trials. These…
Image Credit: © FlowStudio – stock.adobe.com Statistical data monitoring (SDM) plays a critical role in ensuring the quality…
In a recent video interview with Applied Clinical Trials, Jane Myles, program director, Decentralized Trials & Research Alliance…
Image Credit: © Minerva Studio – stock.adobe.com Palatin has shared topline data from the Phase IIb BREAKOUT clinical…
In a recent video interview with Applied Clinical Trials, Jane Myles, program director, Decentralized Trials & Research Alliance…
Image Credit: © Sebastian Kaulitzki – stock.adobe.com Teva and Sanofi have announced positive results from the Phase IIb…
Credit: Axel Kock | stock.adobe.com Data from the OlympiA Phase III trial (NCT02032823) show that Lynparza (Olaparib; AstraZeneca,…
Image Credit: © Egor – stock.adobe.com It’s widely agreed that clinical trial participants should reflect the populations of…
In a recent video interview with Applied Clinical Trials, Jane Myles, program director, Decentralized Trials & Research Alliance…
Guillaume Gigon, VP of Technology and AI, Innovaderm Clinical trials are becoming increasingly data-driven, with sponsors often expecting…
In a recent video interview with Applied Clinical Trials, Jane Myles, program director, Decentralized Trials & Research Alliance…
Kirk Wroblewski, Chief Information Officer, ProPharma Pharmaceutical services companies and now contract research organizations (CROs) currently find themselves…
In a recent video interview with Applied Clinical Trials, Jane Myles, program director, Decentralized Trials & Research Alliance…
Mike Hennessy Jr, president and CEO, MJH Life Sciences® As we near the end of 2024 and reflect…
Applied Clinical Trials December 2024 Issue (PDF) Enhancing eCOA Through AI: A Look Ahead to 2025 Applied AI…
Image Credit: Adobe Stock Images/William As the use of artificial intelligence (AI) has greatly accelerated in recent years,…
In this roundtable discussion, industry experts gathered to address the state of achieving greater diversity in clinical research.…
Shawn Blackburn, President, YPrime Labs The integration of artificial intelligence (AI) and machine learning (ML) into electronic clinical…
Ken Getz, MBA, Executive Director and Research Professor, Tufts Center for the Study of Drug Development, Tufts University…
In a recent video interview with Applied Clinical Trials, Jane Myles, program director, Decentralized Trials & Research Alliance…
Mick Ryan, Vice President, IT, ICON plc Applied Clinical Trials recently spoke with Mick Ryan, vice president of…
Mandis Beigi, Senior Director Afrah Shafquat, Senior Staff Data Scientist Jia Chen, PhD, Senior Director, Medidata AI Jacob…
In a recent video interview with Applied Clinical Trials, Mark Melton, vice president of biospecimen data and operations,…
Image Credit: © iDoPixBox – stock.adobe.com Lantern Pharma has announced that the first patient in its Phase II…
In a recent video interview with Applied Clinical Trials, Mark Melton, vice president of biospecimen data and operations,…
Credit: Arif Biswas | stock.adobe.com Obecabtagene autoleucel (obe-cel; Autolus Therapeutics)—a CD19 chimeric antigen receptor (CAR) T-cell therapy—produced high…
This November, Applied Clinical Trials focused on the topic of empowering patients. While technology has streamlined many operational…
Credit: bluebay2014 | stock.adobe.com The Phase II Piranga trial (NCT04225715) found that the combination of the novel hepatitis…
Credit: oz | stock.adobe.com Merck and Ridgeback Biotherapeutics have announced the initiation of the Phase III MOVe-NOW trial…
Scott Palmese, Executive Director, Site Relationships and DCT Solutions, Worldwide Clinical Trials While decentralized clinical trials (DCTs) have…
In this roundtable discussion, industry experts gathered to address the state of achieving greater diversity in clinical research.…
Image Credit: © putilov_denis – stock.adobe.com The push for greater racial diversity in clinical trials is essential and…
In a recent video interview with Applied Clinical Trials, Mark Melton, vice president of biospecimen data and operations,…
Credit: Thurstan Hinrichsen/peopleimages.com | stock.adobe.com A review of 114 publicly funded non-inferiority (NI) trials in the UK show…
In a recent video interview with Applied Clinical Trials, Jeff Sidell, PhD, chief technology officer, Advarra, discussed current…
Image Credit: © Egor – stock.adobe.com Establishing a robust safety and tolerability profile is essential in clinical development.…
In a recent video interview with Applied Clinical Trials, Jeff Sidell, PhD, chief technology officer, Advarra, discussed current…
Image Credit: © Matthieu – stock.adobe.com Zai Lab and Novocure have announced positive results from the Phase III…
In a recent video interview with Applied Clinical Trials, Jeff Sidell, PhD, chief technology officer, Advarra, discussed current…
November 22nd 2024 Article Patient attrition can be a significant barrier to the success of a randomized controlled…
In a recent video interview with Applied Clinical Trials, Mark Melton, vice president of biospecimen data and operations,…
In a recent video interview with Applied Clinical Trials, Mark Melton, vice president of biospecimen data and operations,…
Applied Clinical Trials November 2024 Issue (PDF) Enhancing Empowerment in Patient-Focused Research Are Any Data in Clinical Trials…
Image Credit: © ipopba – stock.adobe.com Slope and LabConnect have unveiled their new bidirectional API integration. The solution…
In a recent video interview with Applied Clinical Trials, Mark Melton, vice president of biospecimen data and operations,…
Credit: JP STUDIO LAB | stock.adobe.com On the patient side, patient journey coordinators (PJCs) work closely with sites…
In a recent video interview with Applied Clinical Trials, Jeff Sidell, PhD, chief technology officer, Advarra, discussed current…
Image Credit: © photon_photo – stock.adobe.com Merck has announced positive results from its Phase III clinical trial evaluating…
In a recent video interview with Applied Clinical Trials, Jeff Sidell, PhD, chief technology officer, Advarra, discussed current…
Image Credit: © Dr_Microbe – stock.adobe.com AstraZeneca has shared positive, high-level results from the Phase III CAPItello-281 clinical…
Credit: photon_photo | stock.adobe.com Decentralized clinical trials (DCTs) are clinical trials in which some or all trial-related activities…
Image Credit: © Aerial Mike – stock.adobe.com The Global Coalition for Adaptive Research (GCAR) and AstraZeneca have reached…
Modern clinical trials can be an overwhelming experience for participants, compromising everything from medication adherence and data quality…
Modern clinical trials are more complex than ever, and one significant reason is the increased focus on patient…
November 20th 2024 Article AliveCor knows that cardiac safety is critical, with concerns often driving drug withdrawals from…
In this roundtable discussion, industry experts gathered to address the state of achieving greater diversity in clinical research.…
Credit: Dr_Microbe | stock.adobe.com A follow-up analysis of the COLOFOL trial (NCT00225641) showed that differences in the frequency…
Susan Campbell, Global Head of Patient Recruitment, ICON Tinaya Gray, Global Head, Diversity in Clinical Trials, ICON Patients…
Credit: freshidea | stock.adobe.com Results of the Phase II KRAKEN trial (NCT05563246) show that muvalaplin (Eli Lilly) produced…
Image Credit: © BillionPhotos.com – stock.adobe.com As part of its three-year, multi-million-dollar Diversity in Clinical Trials initiative, Abbott…
Credit: Lightgeo | stock.adobe.com Zerlasiran (Silence Therapeutics), a novel N-acetylgalactosamine–conjugated short interfering RNA (siRNA), was found to produce…
Image Credit: © cbies – stock.adobe.com Following a comprehensive internal and external selection process, Pfizer has announced the…
In a recent video interview with Applied Clinical Trials, Mark Melton, vice president of biospecimen data and operations,…
Mike Hennessy Jr, president and CEO, MJH Life Sciences® A popular topic of discussion in clinical research in…
Credit: blacksalmon | stock.adobe.com Findings from the Phase III SUMMIT trial (NCT04847557) show that over a median of…
Scottie Kern, Executive Director, eCOA Consortium at Critical Path Institute The expectation set on the clinical trial participant…
In a recent interview with Applied Clinical Trials, Kelli Aufderheide, director, laboratory decentralized trial solutions, IQVIA Laboratories, discussed…
Credit: luchschenF | stock.adobe.com Interim findings from the Phase III DREAMM-7 trial (NCT04246047) demonstrate that the combination of…
In the second part of this roundtable discussion, participants highlight best practices for reaching underrepresented populations and increasing…
Bimzelx. Image Credit: UCB Two-year data from a series of Phase III trials and their open label extensions…
Image Credit: © Supapeach – stock.adobe.com If clinical trial enrollment is improving, it’s a secret well hidden. PubMed…
Mats Sundgren, PhD, Senior, Industry Science Director, i-HD Gabriel Maeztu, Chief Technology Officer and Founder, IOMED Clinical research…
Brian S. McGowan, PhD, FACEHP, Chief Learning Officer and Co-Founder, ArcheMedX, Inc. So much has been written about…
Hugo Stephenson, MD, Co-Founder and Executive Chair, TrialScreen In the world of clinical trials, patient recruitment remains a…
Credit: Corona Borealis | stock.adobe.com Full results from the Phase III PURPOSE 2 trial (NCT04925752) further demonstrate the…
Image Credit: © Andrii Yalanskyi – stock.adobe.com Advarra has published results from its 2024 Site-Sponsor-CRO Collaboration Survey. Results…
In a recent interview with Applied Clinical Trials, Kelli Aufderheide, director, laboratory decentralized trial solutions, IQVIA Laboratories, discussed…
Drew Bustos, Chief Digital Officer, YPrime In today’s high-stakes clinical trial and drug development environment, technology has become…
Credit: David A Litman | stock.adobe.com A final analysis of the Phase III COMBI-AD trial (NCT01682083) show that…
Image Credit: © Egor – stock.adobe.com Bringing a new treatment to market is a complex process with many…
Case studies: How top biopharma companies are scaling protocol optimization and streamlining data acquisition
In a video interview with Applied Clinical Trials, Jay Park and Rebecca Metcalfe of Core Clinical Sciences discussed…
In a video interview with Applied Clinical Trials, Jay Park and Rebecca Metcalfe of Core Clinical Sciences discussed…
In this roundtable discussion, industry experts gathered to address the state of achieving greater diversity in clinical research.…
jest vape pen i jak działa Jeśli jesteś nowicjuszem w wapowaniu, prawdopodobnie masz kilka pytań. Zacznijmy od podstaw!…
Credit: hapsuwanArt | stock.adobe.com Topline results from the Phase III WAYPOINT trial (NCT04851964) show that Tezspire (tezepelumab-ekko; Amgen…
Image Credit: © JHVEPhoto – stock.adobe.com Johnson & Johnson MedTech has announced the FDA approval of its VARIPULSE…
Image Credit: © photon_photo – stock.adobe.com Zymeworks announced it has dosed the first patient in its first-in-human Phase…
Credit: SachinGusain | stock.adobe.com An interim analysis of the Phase III ALIGN trial (NCT04573478) demonstrated that 36 weeks…
Credit: TinyUU | stock.adobe.com Results from the STEP 9 trial (NCT05064735) show that patients with obesity administered once-weekly…
Image Credit: © Tamara – stock.adobe.com Shockwave Medical, part of Johnson & Johnson MedTech, has announced the first…
Norman M. Goldfarb, Executive Director of the Site Council and Executive Director of the Clinical Research Interoperability Standards…
Credit: Thurstan Hinrichsen/peopleimages.com | stock.adobe.com The clinical trial industry is undergoing significant transformation, particularly in the realm of…
In a video interview with Applied Clinical Trials, Jay Park and Rebecca Metcalfe of Core Clinical Sciences discussed…
Image Credit: © freshidea – stock.adobe.com Teva has shared results from the Phase III SOLARIS (NCT05693935) clinical trial…
Recruitment and retention may appear to be simplistic in their primary functions. However, for these two processes to…
In a recent video interview with Applied Clinical Trials, Jimmy Bechtel, vice president, site engagement, SCRS, discussed key…
Discover how early access to investigational therapies can transform cancer treatment, offering patients new hope and improving clinical…
In a recent video interview with Applied Clinical Trials, Jimmy Bechtel, vice president, site engagement, SCRS, discussed key…
Credit: Olivier Le Moal | stock.adobe.com Data from a pair of Phase III trials presented at the 2024…
Image Credit: © Blue Planet Studio – stock.adobe.com Medable has announced a collaboration with Google Cloud to bring…
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