Site management and site oversight are often used interchangeably in clinical research, but they mean different things. Explore their roles and importance in ensuring successful sites and trials.
- From Lab To Launch: Navigating The Transition To Commercial Readiness
- Working (Well) With Patient Advocates: The Sponsor POV
- Virtual Reality Endpoints Improve Measurement Of Patients' Real-World Benefit
- Working (Successfully) With Pharma: A PAG's Perspective
- The Case For Research-Naive PIs
- Making Medical Innovation Matter To Patients With Simplified Trial Design
- How Should Scientific Focus Change In 2026? Researchers Weigh In
GUEST COLUMNISTS
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![shorten process, simplify, easy communication-GettyImages-2167550769]( "Making Medical Innovation Matter To Patients With Simplified Trial Design")
Making Medical Innovation Matter To Patients With Simplified Trial DesignTo be a leader in today’s environment, Lexicon Pharmaceuticals CMO Craig Granowitz, MD, Ph.D., says companies must embrace simplified clinical trial designs, which can reduce regulatory risks, lower R&D costs, and shorten clinical timelines.
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![old way new way street]( "How Should Scientific Focus Change In 2026? Researchers Weigh In")
How Should Scientific Focus Change In 2026? Researchers Weigh InTo kick off 2026, clinical researchers share how they think research should change in the new year.
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![Make Change happen street sign-GettyImages-470010453]( "Researchers Want A Design Shake-Up In 2026")
Researchers Want A Design Shake-Up In 2026When asked what clinical research professionals should leave behind in 2025, quite a few lamented the stale, even problematic, approach to clinical trial design. Here's what they want done differently in 2026.
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![Health in 2026-GettyImages-2249848425]( "2026: From Experimentation To Operational Reality In Clinical Research")
2026: From Experimentation To Operational Reality In Clinical ResearchVelocity Clinical Research COO Nick Spittal shares several trends he sees shaping up for 2026.
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![Managers inspecting inventory in warehouse, medical supplies-GettyImages-2210267081]( "Sales & Operations Planning for Small Teams: Aligning Clinical Supply")
Sales & Operations Planning for Small Teams: Aligning Clinical SupplySmall clinical teams don’t fail at S&OP from missing systems—they fail from unclear demand and decisions. Alignment comes from discipline, shared visibility, and acting on reality before timelines slip.
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![Medical inquiry-GettyImages-1442715294]( "How To Meet FDA Expectations For Hybrid And Decentralized Trial Oversight")
How To Meet FDA Expectations For Hybrid And Decentralized Trial OversightFormer FDA attorney Claire Davies shares strategies for meeting regulators' expectations for hybrid and decentralized clinical trial oversight.
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![contract, deal, successful agreement-GettyImages-2243745868]( "No Surprise Here: Experts Value Clinical Relevance Over Statistical Relevance")
No Surprise Here: Experts Value Clinical Relevance Over Statistical RelevanceExperts weighed in: “Agree or disagree? Statistical significance is preferable to clinical relevance.”
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![2025-GettyImages-2175709992]( "Trial Matching, Source Data, And More: How Clinical Researchers Used AI In 2025")
Trial Matching, Source Data, And More: How Clinical Researchers Used AI In 2025Researchers reflect on the past year and share how they used AI for clinical research in 2025.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-2154674637-AI-hand-software-ripple]( "Agentic AI And How It's Impacting Clinical Trial Research")
Agentic AI And How It's Impacting Clinical Trial ResearchSince ChatGPT’s launch in 2022, artificial intelligence has transformed industries worldwide—but the next evolution, Agentic AI, promises to be even more profound.
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A Guide to Digital Endpoints in Respiratory Diseases4/15/2025
Learn how wearables and DHTs are alleviating the trial participation burden, increasing the likelihood of trial success, and enhancing the overall management of these conditions.
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Antibody-Drug Conjugates: 'Magic Bullets' Become Reality2/19/2025
Cancer therapy has evolved from potent chemotherapy to targeted biological therapy, including antibody-drug conjugates (ADCs). Learn more about ADCs’ makeup, mechanisms, and the development landscape.
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Patient-Focused Data Capture For Cancer Research8/21/2025
In a field where innovation is constant and patient experience is pivotal, oncology demands eCOA solutions designed to balance scientific rigor with human realities.
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2025 Safety And Regulatory Compliance Trends And Predictions12/16/2024
Explore the rapidly evolving regulatory landscape that pharmaceutical and biotech industries face as they integrate AI and advanced technologies into safety, compliance, and lifecycle management.
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ICH GCP E6(R3) Implementation: Practical Approaches And Real-World Considerations11/21/2025
Access the full brief to learn how a phased, 12–18-month approach can help you meet ICH GCP E6(R3) requirements with confidence and avoid the costly pitfalls many organizations overlook.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Advancing Rare Disease Clinical Trials With Point-Of-Need Eye Assessments1/29/2025
During the COVID-19 pandemic, Applied Genetic Technologies Corporation (AGTC) faced significant hurdles in enrolling participants due to travel restrictions and site limitations.
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Cancer Research UK's Path To Rave EDC And The Medidata Platform6/17/2024
Discover how Cancer Research UK, the world's largest cancer charity, upgraded to Medidata's Rave EDC platform, streamlining clinical trials and enhancing productivity while ensuring minimal disruption.
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Expand Bandwidth With A Trusted Regulatory Writing Partner9/18/2025
Find out how a mid-size biotech lacking the bandwidth, expertise, and resources to independently handle its regulatory writing requirements overcame this challenge.
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Optimizing EDC Strategy And Data Collection for a Rare Disease Trial6/11/2025
Explore how Veristat created a forward-looking roadmap for EDC and CRFs integration for a small biotech sponsor, ensuring a future-ready data ecosystem without overcomplicating current operations.
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Post-Market Safety And Risk Management in DMD4/11/2025
The pharmaceutical company specializing in rare neurological diseases sought solutions after encountering significant hurdles in post-market safety surveillance.
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Optimizing Chronic Cough Phase 3 Trials With Point-Of-Need Eye Assessments1/15/2025
Collaboration was key for Company W to overcome challenges with an FDA-mandated ocular substudy, including limited resources for ocular assessments and logistical difficulties
NEWSLETTER ARCHIVE
- 01.15.26 -- 2 Expectations And 2 Warnings For The Year Ahead
- 01.14.26 -- The Rise Of Antimicrobial Resistance And Strategic Research Imperatives
- 01.14.26 -- STREAM Edition: Smarter CRO Selection And Digital Trends For 2026
- 01.13.26 -- From Experimentation To Operational Reality In Clinical Research
- 01.12.26 -- The Hidden Work That Keeps AMC Trials Moving
RECRUITMENT AND DIVERSITY
This section includes some helpful resources regarding patient recruitment and diversity in clinical trials, including this link to the FDA's guidance on diversity action plans.
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![Time management, deadline-GettyImages-2184911553]( "Confronting \"Time Toxicity\" In Global Oncology And Rare Disease Trials For Operational Excellence And Patient Retention")
Time is the only truly finite resource in a clinical trial. Consultant Leila Cupersmith discusses how sponsors can better design trials with a lower time burden to boost enrollment, retention, and overall operational excellence.
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![Make Change happen street sign-GettyImages-470010453]( "Researchers Want A Design Shake-Up In 2026")
When asked what clinical research professionals should leave behind in 2025, quite a few lamented the stale, even problematic, approach to clinical trial design. Here's what they want done differently in 2026.
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![Medical research, technology, innovation, AI-GettyImages-2226144959]( "The Site Perspective: Why Ambient AI Is The Missing Link In Clinical Trial Data Integrity")
Discover how AI ambient listening has changed the way Mikel Daniels, DPM, MBA, and his team conduct clinical research at WeTreatFeet Podiatry.
FOCUS ON PATIENTS
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![Time management, deadline-GettyImages-2184911553]( "Confronting \"Time Toxicity\" In Global Oncology And Rare Disease Trials For Operational Excellence And Patient Retention")
Time is the only truly finite resource in a clinical trial. Consultant Leila Cupersmith discusses how sponsors can better design trials with a lower time burden to boost enrollment, retention, and overall operational excellence.
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![Make a deal, Successful agreement-GettyImages-2188524624]( "Working (Well) With Patient Advocates: The Sponsor POV")
Aeovian CEO Allison Hulme reflects on Aeovian Pharmaceuticals' partnership with the TSC Alliance and how it’s informed research and development of their first-in-class selective mTORC1 inhibitor.
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![Handshake-GettyImages-2171101482]( "Working (Successfully) With Pharma: A PAG's Perspective")
TSC Alliance President and CEO Kari Rosbeck details the patient advocacy group's unique and fruitful relationship with Aeovian Pharmaceuticals in developing the company's first-in-class selective mTORC1 inhibitor for TSC-related refractory epilepsy.
