Newsletter | November 5, 2026

11.05.26 -- When To Build Out Your ClinOps Team — And Other Advice For First-Time Biotechs

SPONSOR

Turning R&D pressure into strategic opportunity

Insights from the 2026 Pulse Survey of global drug development leaders. Sponsors that approach today’s common biopharmaceutical industry hurdles as opportunities to strengthen clinical development strategy, execution and patient focus may be better positioned for long-term success. Explore this article for deeper insights into the challenges and opportunities shaping modern R&D.

OUTSOURCING MODELS

When To Build Out Your ClinOps Team — And Other Advice For First-Time Biotechs

Small biotechs shouldn't model their ClinOps headcount after Big Pharma. Instead, they need the right capabilities, oversight, and risk controls. Consultant Jessica Cordes explains.

From Friction To Partnership: Becoming The Sponsor Of Choice

Sponsors depend on sites to recruit patients, execute protocols, and collect high-quality data. In this candid panel discussion, we explore what makes sites want to work with a sponsor.

Is Therapeutic Area Expertise The Competitive Advantage We Think It Is?

Rethink vendor evaluation by looking beyond indication experience to discover how cross-trial adaptability, proactive risk management, and team judgment drive true clinical trial resilience.

A Sponsor's Guide To Evaluating CRO Data Governance

Evaluate CRO data governance with a risk-based framework that strengthens data quality, traceability, compliance, and regulatory readiness.

Moving Faster, With Confidence: Interview With Ulrike Bauer

What helps programs advance from development to commercial scale? Ulrike Bauer explores the role of platform flexibility, device readiness and tailored support. Watch now.

Does Your CRO Excel In Oncology Regulatory Publishing?

Oncology approvals move fast. Learn how experienced CRO publishing teams help sponsors navigate RTOR, Project Orbis, and complex global submissions with confidence.

Comparator Selection And Supply: Best Practices For Clinical Success

Explore best practices for comparator selection and supply optimization in clinical trials, including sourcing strategies, risk mitigation, regulatory compliance, and real-world cost-saving case studies.

Metavate: Automated, Metadata-Driven, Data Transformation

Embedded, flexible clinical services model that scales sponsor capacity, standardizes quality delivery, and accelerates clinical development while sponsors retain strategic and operational control.

Renal And Hepatic Impairment Studies

Explore how experienced teams, strategic site partnerships, and comprehensive research capabilities can help streamline complex organ impairment studies and support high-quality outcomes.

Partnering For Functional Solutions

We know that functional outsourcing is vital to clinical development today. This is why we build relationships and communicate with you to develop effective solutions.

Deliver Consistently. Scale Confidently. Adapt Without Friction.

Explore how a next-generation RTSM approach can help CROs scale delivery, improve predictability, and support efficient trial execution across diverse sponsor portfolios.

REGULATORY COMPLIANCE

What The New PDUFA Guidance Means For Drug Development

Learn how the FDA’s updated PDUFA meeting guidance affects sponsor engagement, preparation, and the way feedback shapes drug development.

Dive Into Core Topic Areas Of The HEOR field

Join us to see how HEOR drives impact across the global healthcare landscape.

Harness An Adept IRB's Expertise To Streamline Study Design

An Institutional Review Board protects human research participants by evaluating study ethics, consent, and risks, while providing sponsors with ongoing guidance on complex trial protocols.

Meeting The Complexities Of Modern ADC Development

A strong molecule is no longer enough. Learn how trial strategy and operational readiness can help your cancer therapy reach patients faster.

Who Decides? Navigating AI Governance in Clinical Research

AI in clinical research poses governance challenges. Clear ownership, consistent policies, and aligned teams help manage risk, ensure compliance, and drive responsible innovation in complex trials.

De-Risking FIH: Integrated Strategies For Rapid Proof-Of-Concept

Proper planning for first-in-human studies is crucial to successful drug development, which requires innovative trial designs and sound CMC strategies to mitigate risk and expedite proof-of-concept.

Accelerating Drug Development: Rapid Approvals From 2020–2024

Some drugs reach approval in 3–5 years instead of 8–10. Learn which scientific, regulatory, and operational conditions can help your program cut avoidable delay.

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