The role of the CRO is in flux. As sponsors shift to full-service outsourced (FSO) models to functional service provider (FSP) models, CROs are finding themselves redefining their role in the outsourcing relationship. Jeremy Weitz explains in this two-part series. on the changing role of the CRO.
- Why Site-CRO Relationships Are So Strained — And How To Fix Them
- Overcoming Trial Barriers By Looking Through The Lens Of Product Adoption
- A New Barometer For Clinical Outsourcing Performance
- Understanding How Strategies For Product Adoption Can Inform Clinical Trial Delivery
- What Can Clinical Researchers Learn From Commercial Product Launches?
- AI's Potential Must Reconcile With R&D And Regulatory Bottlenecks
- The Regulatory Affairs Function Is Evolving. Are You Evolving With It?
GUEST COLUMNISTS
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AI's Potential Must Reconcile With R&D And Regulatory Bottlenecks
Evaluate's Daniel Chancellor explains that by working together to expand AI resources and adapt regulatory frameworks, the FDA and others can ensure the benefits of AI are fully realized while maintaining high standards of safety and efficacy.
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The Regulatory Affairs Function Is Evolving. Are You Evolving With It?
The regulatory affairs function is no longer a "one size fits all" function, the decision to outsource or insource the function is growing more complex, and specific AI tools can help regulatory processes.
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What's A Better Tactic For Patient Recruitment — "Unreasonable Hospitality" Or The Same Old?
When it comes to patient recruitment, which is a better strategy: sticking to the same old routine or becoming unreasonably hospitable? Consultant Ross Jackson explores both options.
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How One Biotech Is Using FDA 505(b)(2) To Get Drugs To Patients Quicker And Cheaper
Terran Biosciences CEO Sam Clark, MD, Ph.D. explains how his team is leveraging the 505(b)(2) regulatory pathway to get its new schizophrenia drug to patients quickly and affordably.
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An Expert Guide To Effective Sponsor Oversight In Clinical Trials
Consultant Jessica Cordes explains how combining thorough sponsor oversight with robust risk management practices, sponsors can significantly enhance the quality and reliability of clinical trials.
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The Crucial Role Of Sponsor Oversight In ICH E6 (R3)
ADRES Bio leaders Inbal Hacmon and Rivka Zaibel delve into the critical aspects of ICH E6 (R3), shedding light on its implications for clinical trial sponsor responsibilities.
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Massive Data, More Decentralization Drive Updates To ISPE GAMP Guide
ISPE GAMP Guide lead author Frank Henrichmann describes the changing clinical data environment and details updates that will support the work of various clinical trial stakeholders.
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Site Visits 101: Visits Before, Without, And After Trial Participants
Discover the primary visit types that occur at a clinical research site before, without, and after the presence of clinical trial participants.
CLINICAL TRIAL WHITE PAPERS
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Peanut Allergy: Asia Pacific Clinical Trial Landscape
Explore the differences between the common food allergies in Asia and the West, specifically the peanut allergy.
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Strategies For Post-Approval Lifecycle Management And Local PV7/12/2024
If you are unsure of how to navigate your post-approval regulatory journey, an experienced regulatory services partner can provide support to help you identify and achieve post-approval goals.
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Optimal COA Measurement Strategy In Modern Oncology Trials: Insights8/29/2023
Explore the challenges and opportunities in implementing patient-reported outcome measures (PROMs) in oncology trials. This article discusses the recent FDA draft guidance, emphasizing how more targeted PROM strategies could lead to better medication labeling and patient care in cancer treatment.
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Decentralized Manufacturing And The Accessibility Of CGTs7/24/2024
Discover how ProPharma’s decentralization solution can streamline the delivery of cell and gene therapies, ensuring cost-effective, compliant, and local patient care.
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4 Ways FSP Models Are Being Used To Drive Success9/11/2023
Dive into several case studies where clients have leveraged clinical research services to surmount critical challenges within the industry and accelerate their achievements.
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Navigating The Privacy Tightrope For CTIS9/19/2023
Examine the challenges, potential risks, recommended best practices, and future trends related to anonymizing personal data for Clinical Trials Information System submissions.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Unraveling Duchenne Muscular Dystrophy6/27/2023
Rare disease studies in remote locations often face logistical challenges to completion. Explore the effective impact personalized patient support services can have on clinical trial success.
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Biotech Files NDA Following Risk-Based Mock Inspection6/14/2023
See how the preventative approach an emerging biotech company took to mitigate risks and identify potential concerns before their FDA inspection and NDA submission ultimately led to success.
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eCOA: Unified Approach Streamlines Processes, Speeds Start Up And Improves Data Quality5/8/2024
Discover how a leading biopharmaceutical company revolutionized its clinical development with an eCOA solution that optimized its processes, cut build times, and enhanced data quality.
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Patient Caregiver Network Improves Post-Seizure Trial Data3/26/2024
Discover how a pharmaceutical CRO addressed concerns about seizure diary timing in a rare disease study, leveraging insights from Medable's Patient Community Network to optimize data collection.
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Research Site Network Enhances Study Startup With Reliable ICF Writing Services5/17/2023
With help from a new informed consent form (ICF) writing partner, discover how CenExel Clinical Research was able to streamline processes and launch new studies faster.
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Global Regulatory Excellence Throughout The Clinical Development Lifecycle5/8/2024
Navigating the intricate global regulatory path is crucial for clinical development success. See how expert-backed support has consistently propelled sponsors toward regulatory excellence.
NEWSLETTER ARCHIVE
- 10.21.24 -- The DEI Dilemma: Separate Teams Or Embedded Methods?
- 10.21.24 -- Boost Efficiency While Ensuring Data Integrity In Clinical Trials
- 10.18.24 -- What Can Advanced Analytics Do For ClinOps?
- 10.18.24 -- Partners Ready To Support Your Phase 1-3 Trials
- 10.17.24 -- Why Moving More Cancer Trials Into The Community Benefits Patients And Sponsors
CONTENT COLLECTIONS
FOCUS ON PATIENTS
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In the final article of this series, Liam and Kim Eves explore how various drug candidates come inherent with barriers to adoption that directly impact how participants and providers engage with clinical research.
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In part two of this series, Liam and Kim Eves discuss product archetypes and adoption drivers as they relate to commercial endeavors and looks closely at how they can be applied to clinical trial execution.
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Part one of this three-part series exploring modern drug development and its impact on clinical trials and new drug launches connects product adoption concepts with much earlier clinical trial activities.
RECRUITMENT AND DIVERSITY
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In the final article of this series, Liam and Kim Eves explore how various drug candidates come inherent with barriers to adoption that directly impact how participants and providers engage with clinical research.
-
In part two of this series, Liam and Kim Eves discuss product archetypes and adoption drivers as they relate to commercial endeavors and looks closely at how they can be applied to clinical trial execution.
-
Part one of this three-part series exploring modern drug development and its impact on clinical trials and new drug launches connects product adoption concepts with much earlier clinical trial activities.