Newsletter | February 19, 2026

02.19.26 -- Could Moving To This Swiss Life Sciences Hub Be In Your Company's Future?

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A 2-hour virtual expo for clinical trial professionals to quickly evaluate EDC, eCOA, and data management technologies. Attendees can watch concise 15-minute demos from leading vendors, compare solutions side by side, and ask questions in real time—without travel or high costs. Ideal for pharma and biotech teams seeking faster, more confident technology decisions for current or upcoming trials. Click here to learn more.

REGULATORY & COMPLIANCE

From Lab To Launch: Navigating The Transition To Commercial Readiness

Many clinical-stage companies start thinking about commercialization too late. FTI Consulting experts team up to provide guidance on getting started early.

Why Big Pharma Is Shifting Toward FSP Solutions

Samir Shah describes how large pharmaceutical companies are moving decisively toward FSP-derived models. He explains how AI investments, cost efficiency, and improved control over operations are driving a lasting structural shift — not a short-term trend — across the industry.

Five Ways Site-Facing Technology Helps Sponsors And CROs

Site-facing technology is presented as a crucial enabler of efficient trial execution, aligning site operations with sponsor timelines and objectives.

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.

Why Biotech CRO Partnerships Are Essential For Clinical Trial Success

For early-stage biotech companies, the road from discovery to market is fraught with challenges, and in this environment, strategic partnerships with CROs have become a cornerstone of clinical success.

Advanced Drug Delivery And Device Combination Product Solutions

PCI Pharma Services' end-to-end injectable services, comprehensive approach, and dedication to excellence provide convenient, easy-to-use, patient-centric therapies.

Turnkey Solutions For Your Renal And Hepatic Impairment Studies

With three clinical pharmacology units, access to 145,000+ hepatic/renal patients, and 100+ completed studies, we’re your partner for NDA-enabling trials.

OUTSOURCING MODELS

Could Moving To This Swiss Life Sciences Hub Be In Your Company's Future?

Basel Area Business & Innovation CEO Christof Klöpper discusses how the Basel Area Life Sciences Supercluster supports discovery through commercialization.

Is Your Clinical Trial Portfolio CTIS Compliant?

The Clinical Trials Regulation and its centralized digital platform, the Clinical Trials Information System (CTIS), are now mandatory. Are you prepared to navigate your next clinical trial in the EU?

What The FDA Looks For In Global Development Programs Today

Mastering the complexities of multi-regional clinical trials requires aligning global data with evolving regulatory expectations to ensure treatment consistency and successful drug approval.

Is Your Clinical Research Site GCP-Ready?

By fostering a culture of continuous improvement through internal audits, clinical research sites can identify non-compliance issues and enhance their research practices.

EU GMP Annex 11: Compliance Strategy And Digital Solutions

Explore how EU GMP Annex 11 revisions could reshape global pharmaceutical compliance, as well as strategies for navigating implementation challenges and building future-ready validation programs.

CHOOSE YOUR OWN ADVENTURE

You're receiving the Thursday edition of the Clinical Leader newsletter, focusing on Outsourcing Models and Regulatory & Compliance. To make changes to your newsletter selections, update your topic preferences.

  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)

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