Authors

Drew Garty

Chief Technology Officer, Veeva Clinical Data

Latest Article

A Look Back: AI and Pragmatic Trials Took Center Stage at SCOPE Summit 2025

Revisit top insights from SCOPE Summit 2025, where industry leaders explored how artificial intelligence is reshaping trial risk management and how pragmatic study designs are bridging the gap between clinical research and real-world care.

Nicholas Jacbous
Latest Article

FDA Announces Ramifications of Government Shutdown Due to 2026 Lapse in Funding

FDA outlines its limited operations during the funding lapse, focusing on essential public health activities while halting new drug applications.

Rohit Mistry

CEO, IOMED

Latest Article

Harnessing Unstructured Data and Hospital Interoperability

The potential of next-generation platforms in transforming patient recruitment.

Rhiannon Hyde

Director, Governance and Transformation, uMotif

Latest Article

Partners for Success: Governance Best Practices to Streamline eCOA Trial Launch

Strong relational governance between technology vendors and sponsor–CRO teams is becoming a critical foundation for eCOA trial success, enabling faster study launches, clearer communication, proactive issue management, and sustained quality across entire trial portfolios.

Aleksa Jovanovic MD, PhD

Scientific Engagement and Innovation Specialist, Wemedoo AG

Latest Article

Clinical Trial Failure: A Data-Driven Perspective on Risk Mitigation

An increase in protocol complexity is paving the way for machine learning models to optimize trial design.

CenExel
Latest Article

Advancing Clinical Research in GLP-1 Therapies: Insights From a Principal Investigator

Webinar Date/Time: Thu, Jan 22, 2026 11:00 AM EST

Altair
Latest Article

Powering Clinical Operations With Knowledge Graphs and LLMs With Merck KGaA, Darmstadt, Germany

Webinar Date/Time: Thu, Mar 13, 2025 11:00 AM EDT

Sharad Adekar, MD, PhD, CIP

Senior Medical Chair at WCG’s IRB in Puyallup, Washington

Latest Article

Engineered Bispecific Antibodies: Regulatory, Ethical, and Best Practice Guidelines

Ethical and regulatory considerations for safeguarding participants in bispecific antibody clinical trials, and best practices designed to optimize their success.

Scott Foster

Managing Director at NFP

Latest Article

Clinical Trial Failure Isn’t an Inevitable Risk—It’s Insurable and Opening the Door to New Investors

Clinical trial failure insurance is turning biotech’s most costly risk into a manageable asset, opening new pathways for funding and innovation.

Martha Azer, PharmD

Associate Director, Regulatory Policy North America, Johnson & Johnson

Latest Article

Digital Measures of Health: What’s in it for Patients?

Exploring the different stages in the development of a digital measure, and the activities and steps key to achieving meaningful impact for patients.

Justine Koor

Justine Koor, Director, Quality Assurance at IQVIA

Latest Article

Preparation Tips to Minimize Impact of Regulatory Inspections for IRT Systems

Regulatory inspections of interactive response technology systems have surged 140% since 2022, signaling intensified global scrutiny of data integrity, randomization, and system validation in clinical trials.

Kara Bastarache, CAE; Ruma Bhagat, MD, MPH; Beth Bieze, MA, CCRA, ACRP-PM, FACRP; Kimberly Demirhan, MBA, BSN, RN; Mona Gilliam, MSN, APRN-BC, CNS; Susan P. Landis, BA; Katie Marceau, RN, MS-NL, OCN, CCRP; Nicole Richie, PhD; Latha Shivakumar, PhD; and Marian Valia
Latest Article

Upskilling Community Cancer Centers: A Training Pilot Hints at Promising Ways to Boost Oncology Clinical Research

This pilot project evaluated whether targeted training could strengthen clinical research capacity at community cancer centers, improve readiness to conduct oncology trials, and support more inclusive patient enrollment by addressing barriers, building foundational skills, and increasing staff confidence in trial implementation.

Syed Fazle Rob, RPh

Head of Global Business development, AF Pharma Distribuce léčiv s.r.o.

Latest Article

Securing Comparator Drugs in Competitive EU Markets: Challenges and Practical Solutions

Comparator drug sourcing in the EU is shaped by a defined set of availability, regulatory, competitive, and logistical pressures, alongside practical strategies to reduce risk and protect trial timelines.

Ashley Daigneau

Head of Clinical Trials at Verana Health

Latest Article

Proactive Planning is Key to Mitigating Study Rescue

Leveraging real-world data and AI-driven insights in clinical trial planning can reduce enrollment failures, improve retention, and prevent costly rescue studies by providing a more accurate view of patient populations and site feasibility.

Sowmyanarayan Srinivasan, Tanvi Vedhera, Garima Prashad, and Vishakha Sharma
Latest Article

Leveraging Technology for Efficient Trial Design

Teams must work together with technology solutions and optimize integration to unlock their full potential.

Kenton Zavitz, PhD

Director, Clinical Affairs, Cambridge Cognition

Latest Article

The Importance of Using Cognition as an Endpoint in Clinical Trials

How cognitive evaluations can aid in meeting the growing demand for more comprehensive safety profiles.

Shadi Cinpinski, MHA

Director, Therapeutic Strategy, Oncology, IQVIA

Latest Article

Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025

At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.

Mats Sundgren, Sarah Burge, Lars Fransson, Adriano Garcez, Joeri Holtzem, Gabi Maetzu, Thomas Metcalfe, Steve Tolle, Felix Nensa, and Joe Lengfellner
Latest Article

Unlocking Unstructured Health Data: Scaling eSource-Enabled Clinical Trials

New research finds that while eSource adoption is advancing through EHR-to-EDC workflows, scaling its impact will depend on integrating unstructured clinical data using AI, shared standards, and collaborative validation models across sites, sponsors, and vendors.

Nicholas Jacobus
Latest Article

Novo Nordisk Submits Higher-Dose Wegovy Injectable for FDA Approval with Priority Voucher

The company submitted the new dosage for approval based on its Phase III trial results.

Devin Ridgley, PhD

Director, Project Management, Medical Device and Diagnostics Research, ICON

Latest Article

Clinical Strategies to Optimize Software as a Medical Device to Treat Mental Health

With close collaboration between sponsors, CROs, and regulators, this emerging technology has the potential to greatly improve the lives of patients.

Inger Ødum Nielsen, Vanessa de Langsdorff, and John April
Latest Article

How Medical Writing and Regulatory Affairs Professionals Can Embrace and Deploy Generative AI at Scale

Unlocking the full potential of artificial intelligence requires these stakeholders to ensure their data are accessible and secure.

Christine Senn, PhD, FACRP

Senior Vice President of Site-Sponsor Innovation, Advarra

Latest Article

2025 SCRS Global Site Solutions Summit Recap: Moving to True Partnerships

In this special recap of the most recent SCRS Global Site Solutions Summit, we highlight insights gained from KOLs on-site that emphasize the importance of communication and collaboration between sites and sponsors/CROs.

Afrah Shafquat

Senior Staff Data Scientist, Medidata Solutions

Latest Article

Accelerating Breakthroughs with Synthetic Clinical Trial Data

The emergence of AI-powered simulants in improving study efficiency.

F Sandesh Vijohar, MD; Nailesh Patel, PhD; Chirag Shah, PhD; Devanshee Patel, Pharm D; Mustafa Pardiwala, PG; and Raj Kumar, MBA
Latest Article

Overcoming Operational Challenges in Oncology Clinical Trials: Lessons from a Multicentric Study in India

Case study highlights how clinical operations teams can overcome complex regulatory and operational hurdles to finish a trial on time and on budget.

Brad Cunningham

Head of Strategic Partnerships at Verana Health

Latest Article

Tokenization: The Unsexy Plumbing of Clinical Research

As clinical research increasingly relies on RWD to enhance trial design and patient insights, tokenization has emerged as a critical solution for securely linking disparate datasets while protecting patient privacy.

Ken McFarlane

Vice President, Strategic Consulting, CluePoints

Latest Article

Detecting Fraud in Clinical Trials Using Statistical Data Monitoring

Exploring stat-based testing for variables that identify deliberate data manipulation in clinical trials.

Natalie Marquess, ARM, CIC, CRM

Director - Business Development, Life Sciences at Aon

Latest Article

Clinical Trial Failure Isn’t an Inevitable Risk—It’s Insurable and Opening the Door to New Investors

Clinical trial failure insurance is turning biotech’s most costly risk into a manageable asset, opening new pathways for funding and innovation.

Farrell Healion

Founder and Principal Consultant, OptiTrial


Latest Article

Answering the Sustainability Call: Digital Health Technologies and eCOA

Sustainability should be central to clinical trial design and considerate of how digital tools such as electronic clinical outcomes assessments can help achieve this.

Kristin Tolbert

Associate VP of Health Equity Strategy at Jumo Health

Latest Article

Pregnant Women: An Underrepresented Group in Clinical Trials

Recent research is showing medical treatment for pregnant women often relies on clinical data from non-pregnant female patient populations.

Cindy Henderson

Chief Strategy Officer, Veristat

Latest Article

Navigating Complexity: Strategies to Accelerate Modern Clinical Trials

As clinical trials become more complex, success depends on early collaboration, thoughtful protocol design, and practical strategies to manage risk, reduce delays, and support patients.