12.04.25 -- Two Former FDA Chiefs, Two Very Different Warnings

As diversity plans and multi-regional considerations become core to trial design, early-phase oncology programs must navigate a landscape that offers unprecedented opportunity.

If you want to increase speed and reduce costs while still procuring high-quality data for your clinical trial, consider the impact of launching an early-phase clinical trial in Australia.

Find the practical implications faced by investigators and their support staff, such as navigating new bureaucratic procedures and adhering to revised regulatory requirements.

This 2024 Industry Pages report provides an in-depth examination of the Central and Eastern European (CEE) clinical trial strategy, highlighting its pivotal role in global drug development.

Using QRM gives a company the ability to maintain compliance while also identifying product issues that could be harmful to the consumers, some being susceptible patients.

Targeted therapies, immunotherapies, antibody-drug conjugates, and other biologics demand a patient-centered strategy that recognizes that higher doses do not always translate to better outcomes.

Explore the collaboration that enabled FDA approval of a novel chronic-condition therapy, rescued a high-risk program, and demonstrated a unified “one-team” approach by reworking the sponsor's SAP.

Discover how offering sponsors end-to-end strategic drug development and technology-enabled regulatory services helps to reduce time, cost, and risk, from discovery through post-registration.

In a landscape where speed, quality, and trust are inseparable, choosing a CRO that shares your ambition is not optional; it is essential to survival and success.

Most clinical trials overlook one crucial factor: giving sites and patients a voice in how studies are run. That’s starting to change—and the impact is significant.

Clinical research teams thrive in the Flow State, where systems align, data connects, and work becomes purposeful, not painful. Ease is clarity, not complexity.

Explore how this facility can enhance your drug development process by providing cutting-edge bioanalytical testing solutions and seamless global support.

Stability testing is essential to ensuring your drug’s stability, potency, efficacy, and safety under different controlled conditions throughout development, manufacturing, and life cycle management.

A global CRO united 300+ leaders for a dynamic, space-themed meeting that strengthened culture, deepened product understanding, and inspired alignment toward annual growth goals.

With over 30 years of experience, Altasceinces delivers customized and scalable CRO services purpose-built for early-phase to Phase Ib/IIa development.

Re-engineer your drug's path into clinical development and accelerate time to Proof-of-Concept. Real-time data guides rapid formulation iterations, minimizing drug substance use and lowering program risk.

Learn how DTP clinical supply enables participants to receive treatments in the convenience and comfort of their own homes while reducing (or eliminating) the need to travel to a clinical site.

Check out our global network of more than 800 rigorously trained, calibrated expert raters who deliver consistent, independent assessments supported by continuous quality oversight.

Solve the unique challenges of poorly soluble molecules like targeted protein degraders (TPDs), such as PROTACs and molecular glues, seamlessly accelerating your molecule from to commercialization.