The question is not whether trust matters but how industry, sponsors, and investigators can bridge the trust gap to drive patient participation.
- Why Dr. Robert Califf Isn't Pulling His Punches Anymore
- The U.S. Trial Advantage Is Eroding
- Making AI Safety Routine: How Sites And Sponsors Can Continuously Monitor Clinical AI
- Want To Optimize Clinical Project Team Performance? Try This Formal 'Lessons Learned' Process
- 4 Factors Changing The Way CRAs Monitor Trials
- Choosing Clinical Research … On Purpose
- How Can AI Change Computerized System Validation?
GUEST COLUMNISTS
-
![Business Quality Assurance and Compliance-GettyImages-2225358412]( "How Can AI Change Computerized System Validation?")
How Can AI Change Computerized System Validation?Learn how AI technologies are changing the computer system validation (CSV) landscape and what you need to understand about this transformation.
-
![bechtel getz series article 2]( "Too Little Info, Too Much Time Wasted: Feasibility Challenges For Sites")
Too Little Info, Too Much Time Wasted: Feasibility Challenges For SitesIncomplete protocols, lengthy sponsor decision timelines, and uncompensated work plague clinical research sites. Learn why these issues exist and how to address them alongside experts from SCRS and Tufts CSDD.
-
![digital platform, artificial intelligence, machine learning, processing for mental health-GettyImages-2234202465]( "Will New AI Health Assistants Suggest Clinical Trials To Inquiring Patients?")
Will New AI Health Assistants Suggest Clinical Trials To Inquiring Patients?New AI health assistants are now doing even more to help patients make sense of symptoms, diagnoses, and treatment options. What does that mean for the discoverability of clinical trials?
-
![Diverse business team-GettyImages-2198573359]( "What CROs Do Right Isn't Always Obvious To Research Sites")
What CROs Do Right Isn't Always Obvious To Research SitesCROs are doing many things right. But it's when that right thing is understood — not just executed — that the impact becomes far greater than compliance alone.
-
![friends laughing-GettyImages-1488926575]( "How Gilead Includes Patients Most Affected By HIV In Its PrEP Trials")
How Gilead Includes Patients Most Affected By HIV In Its PrEP TrialsVP of Clinical Development, HIV, Moupali Das shares how the sponsor approaches diverse participant recruitment and enrollment, highlighting the importance of early demographic research and careful, intentional PI selection.
-
![tablet with number 2026-GettyImages-2245485086]( "3 Clinical Research Attorneys Talk 2026 Trends")
3 Clinical Research Attorneys Talk 2026 TrendsThree life sciences legal experts share what they see happening in the year ahead — and what should remain firmly in the past.
-
![Business Risk Management-GettyImages-2151106988]( "The \"One-Trial\" Trap: Why 2026's FDA Efficiency Push Actually Doubles Your Operational Risk")
The "One-Trial" Trap: Why 2026's FDA Efficiency Push Actually Doubles Your Operational RiskWhen it comes to the FDA's new "one-trial" shift, researcher Johnathon Anderson, Ph.D., warns: Do not confuse efficiency with leniency. Here, Anderson offers three factors to consider when adapting to new FDA trial expectations.
-
![Business performance evaluate checklist review-GettyImages-2150709873]( "Common Issues And Trends In Clinical Research Vendor Qualification")
Common Issues And Trends In Clinical Research Vendor QualificationDiscover the biggest challenges in vendor qualification, including this one misalignment that affected more than half of surveyed respondents.
CLINICAL TRIAL WHITE PAPERS
-
![2025 business outlook-GettyImages-2179048246]( "What Clinical Trial Decision Makers Are Prioritizing In 2025")
What Clinical Trial Decision Makers Are Prioritizing In 2025In 2025, clinical trial operations are undergoing a transformative shift driven by the need for speed, cost-efficiency, and patient-centered approaches.
-
What the FDA Looks For In Global Development Programs Today1/16/2026
Mastering the complexities of multi-regional clinical trials requires aligning global data with evolving regulatory expectations to ensure treatment consistency and successful drug approval.
-
PV Solutions Optimizing End-To-End Safety In Clinical Development3/6/2024
Explore what the future of PV services and technology in the life sciences industry could look like if innovation, regulatory vigilance, and collaboration with regulatory bodies were prioritized.
-
Accelerate Drug Development With Master Protocols5/15/2025
Through careful planning, aligned incentives, and an open, adaptive mindset, master protocols become powerful engines for accelerating therapies to market—particularly in high-need therapeutic areas.
-
Master Protocols: Implementing Effective Treatment Adaptations8/25/2025
From balancing treatment ratios and managing eligibility to accommodating site-specific readiness and protocol amendments, a well-designed IRT system enables seamless transitions.
-
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.
CLINICAL TRIAL APP NOTES & CASE STUDIES
-
Pioneering The End-To-End Decentralized Trial Experience4/16/2025
This collaboration highlights the potential of decentralized clinical trials (DCTs) to transform trial execution, as well as offering a replicable model for future research.
-
Streamlining Study Start-Up For Accelerated Drug Development2/20/2024
What is the secret to safely expediting study start-ups? Explore our case study to find out how open dialogue, aligned expectations, and direct communication between Altasciences’ team leads and sponsor contributed to a clinical trial start-up of only 3.5 weeks.
-
Muscular Dystrophy: Multi-National And Multi-Site Trials10/15/2024
Learn about the success ReveraGen found when expanding their partnership with Novotech to a larger phase 2b trial (VBP15-004) in Duchenne Muscular Dystrophy (DMD).
-
Digitizing And Standardizing Participant Pain Body Maps6/13/2024
Explore how digitizing clinical trial processes, such as paperless "body map" assessments, can enhance efficiency and standardization in pharmaceutical trials.
-
A Community-Focused Approach To Metabolic Disease Trials8/28/2024
Learn how innovative strategies like free health exams, community engagement, and a comprehensive patient database helped this project achieve rapid enrollment with a high level of patient diversity.
-
Cutting Red Tape: Direct Data Capture In Clinical Trials4/12/2024
Say goodbye to duplicate work in clinical trials. Discover how Direct Data Capture revolutionizes research, benefiting patients, sponsors, and sites while streamlining processes.
NEWSLETTER ARCHIVE
- 02.04.26 -- Is Your Team Burnt Out? Discover The ROI Of Healthy Employees Running Trials
- 02.04.26 -- STREAM Edition: Data Cleaning And Site Performance
- 02.03.26 -- Common Issues And Trends In Clinical Research Vendor Qualification
- 02.02.26 -- Preeclampsia Research's Urgently Needed For Funding And Patient-Informed Trial Design
- 01.30.26 -- How Can Sites And Sponsors Continuously Monitor Clinical AI
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.
-
![Medical examination of woman using ultrasound equipment of liver kidneys-GettyImages-1482783655]( "Building Patient Trust In Research Through Connection Driven-Transparency")
The question is not whether trust matters but how industry, sponsors, and investigators can bridge the trust gap to drive patient participation.
-
![Healthcare Questions-GettyImages-2193936936]( "Patient Trust In Pharma Is Low; Here's How To Rebuild It")
CISCRP's Annick de Bruin and Shalome Sine provide strategies for building patient trust based on the findings from their Perceptions & Insights Study.
-
![American Flag-GettyImages-2256012795]( "The U.S. Trial Advantage Is Eroding")
Once the go-to location for trials, the U.S. is now seeing competition from APAC, driven by political, economic, and workforce pressures domestically and rapid growth abroad.
FOCUS ON PATIENTS
-
![Medical examination of woman using ultrasound equipment of liver kidneys-GettyImages-1482783655]( "Building Patient Trust In Research Through Connection Driven-Transparency")
The question is not whether trust matters but how industry, sponsors, and investigators can bridge the trust gap to drive patient participation.
-
![Healthcare Questions-GettyImages-2193936936]( "Patient Trust In Pharma Is Low; Here's How To Rebuild It")
CISCRP's Annick de Bruin and Shalome Sine provide strategies for building patient trust based on the findings from their Perceptions & Insights Study.
-
![friends laughing-GettyImages-1488926575]( "How Gilead Includes Patients Most Affected By HIV In Its PrEP Trials")
VP of Clinical Development, HIV, Moupali Das shares how the sponsor approaches diverse participant recruitment and enrollment, highlighting the importance of early demographic research and careful, intentional PI selection.
