Clinical Operations & Strategy

How a strategic approach to the pre-investigational and investigational new drug application process can be used as a business and clinical catalyst.

Capturing insights from clinical research professionals on the key trends and challenges shaping drug development today, from those in clinical trial operations and site relationships, to technology and AI, and the evolving regulatory and policy terrain.

Ways to identify false certainty, or "errogance," during the clinical site start-up-to-launch process—and better ensure site readiness and prevention of costly errors.

In this episode of the ACT Podcast, we highlight a recent Q&A featuring Ibrahim Kamstrup-Akkaoui, vice president of data systems innovation at Novo Nordisk; and a feature article by Chris Driver, senior director of product management, Patient Suite at IQVIA, in which they both highlight how sponsors are adopting automation to streamline operations.

Tom Cowen, head, healthcare, life sciences, Conga, explains why investigator onboarding creates significant delays in clinical trials and how smarter contract management can help sponsors accelerate study start-up.

In this video interview, Ananth Kadambi, VP of real-world evidence and modeling solutions at Certara, outlines how FDA’s emphasis on overall survival in oncology trials requires stronger safety monitoring, subgroup planning, and patient tracking.

In this video interview, Umesh Chaudhari, executive medical director and global program head of the C5 programs at Regeneron, describes how double-blind double-dummy dosing, standardized assessments, and site training ensured protocol adherence and data integrity in the NIMBLE trial.

In this video interview, Adrianne Rivard, senior community development manager at myTomorrows, explains why compliance with privacy standards and physician training are critical for safe and effective use of GenAI in clinical trial discovery.

A new systems-based framework helps sponsors and CROs move beyond prediction to understand why site selection succeeds or fails, enabling targeted interventions that boost recruitment, data quality, and trial efficiency.

Craig Lipset, co-chair, Decentralized Trials & Research Alliance (DTRA), and Kyle McAllister, co-founder, CEO, Trially, discuss how research sites are navigating political funding pressures, adapting to NIH budget constraints, and leveraging new cost-containment strategies to sustain clinical research.

In this video interview, Caroline Potts, general manager of sites and patient services at Medical Research Network (MRN), highlights how listening to site insights and adopting flexible models such as temporary community-based clinics, can reduce patient travel burdens, improve enrollment efficiency, and stretch trial budgets further.

An overview of how recent funding reductions are reshaping clinical trial operations, from site sustainability and patient recruitment to trial design and long-term strategy.

In this video interview, Caroline Potts, general manager of sites and patient services at Medical Research Network (MRN), outlines how rigid budgeting and limited sponsor-site dialog often block innovative patient-centric solutions, stressing the need for more collaborative approaches to enable community engagement and flexible trial delivery.

In this video interview, Caroline Potts, general manager of sites and patient services at Medical Research Network (MRN), explains why site-enabled approaches such as in-home visits and community-based outreach should be offered from the start of a trial to reduce recruitment delays, support patient needs, and improve trial diversity.

In this video interview, Caroline Potts, general manager of sites and patient services at Medical Research Network (MRN), discusses the challenges of achieving true operational flexibility in clinical trials—highlighting how SOPs, staffing, and budget constraints often limit site adaptability and contribute to staff burnout.

A 2025 survey highlights growing momentum for multi-indication drug development, with opportunities in innovative trial design, targeted patient selection, and real-world evidence to speed label expansion.

In this video interview, Meri Beckwith, Co-CEO of Lindus Health, shares practical ways clinical teams can strengthen trial protocols for expedited programs—such as incorporating control groups where possible, leveraging synthetic and real-world data, and adopting adaptive trial designs to reduce regulatory risk.

Ron Lanton, partner, Lanton Law, explains why evolving federal guidance and new technologies are pushing clinical operations teams to strengthen oversight and safeguard the credibility of clinical research.

In this Q&A, Rohit Nambisan, CEO of Lokavant, and Jonathan Crowther, head of predictive analytics, Pfizer, explore how AI is transforming study feasibility, regulatory review, and trial execution.

In this video interview, Meri Beckwith, Co-CEO of Lindus Health, discusses whether recent trial design rejections signal a broader shift in FDA expectations or simply reflect changes in individual reviewers, emphasizing that current unpredictability may be more situational than systemic.

In this video interview, Meri Beckwith, Co-CEO of Lindus Health, explains why sponsors pursuing breakthrough or priority review designations must maintain rigorous trial design while building organizational agility.

In this video interview, Meri Beckwith, Co-CEO of Lindus Health, discusses recent Complete Response Letters issued to Replimune and Capricor, explaining how shifts in FDA reviewers can affect single-arm trial acceptance, especially in oncology settings where control groups may be deemed unethical.

A unified technology approach improves study efficiency and data collection.

In this video interview, Luke Wilson, senior director, biotech, pharma services at Thermo Fisher Scientific, shares key strategies for maintaining operational alignment and compliance in decentralized trials including unified data platforms, aligned SOPs, and clear governance and escalation pathways between sponsors and supply chain partners.

In this video interview, Luke Wilson, senior director, biotech, pharma services at Thermo Fisher Scientific, outlines the key barriers to real-time oversight in clinical trials and explains how integrated systems, built-in analytics, and live dashboards can empower clinops leaders to make faster, better-informed decisions.