12.11.25 -- FDA First: Dompé Secures a Commissioner's National Priority Voucher

The development process for these products is complex, requiring careful consideration of regulatory requirements, technical feasibility, clinical efficacy, and patient-centered design.

Chris Roe, principal research fellow at Quotient Sciences, discusses effective strategies to overcome biopharmaceutic challenges for small molecules in today’s drug development pipeline.

Facing economic pressures, regulatory changes, and technological advancements, CROs must redefine their value propositions and discuss the need for reinvention in 2025 to accelerate into the future.

We share important factors to consider when weighing your contract service provider options. These “Three Cs” can indicate whether a service provider has the capabilities desired by a drug sponsor.

The right bioanalysis CRO accelerates progress, while the wrong one can derail outcomes. When every provider claims speed and credibility, how do you confidently choose the right partner?

Vendor selection isn’t just procedural — it shapes trial outcomes. Even with a solid process, missteps can ripple through timelines, budgets, and team morale. Choose wisely.

Leveraging incurred sample reanalysis (ISR) in your quality control helps your team mitigate risks, establish regulatory compliance, and instill confidence in your pharmacokinetic modeling.

Our team in Japan provides comprehensive services including primary and secondary clinical packaging and labeling, comparator sourcing, cold chain storage, and local and global distribution.

Recovering lost clinical trials is an art. Learn how we triage your study’s problem areas, build recovery strategies to address your drifting trial’s performance, and deliver results.

With a strong focus on the Life Sciences industry, this program provides financial assistance, hands-on industry experience, and valuable international visibility for emerging innovators.

From complex study designs and evolving regulations to time-sensitive treatment protocols, advancing oncology clinical trials present significant challenges for investigators, sites, and patients.

We provide a complete range of bioanalytical solutions, including method development, validation and transfer; PK and PD Bioanalysis, ELISA and multiplex assays, bioassays, immunogenicity testing.

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?

Learn how sponsors, CROs, and monitors can meet FDA expectations and IRB requirements when incorporating AI and Software-as-a-Medical-Device into clinical trials.

Review the ripple effects of drug price controls, including recent U.S. policy shifts like the IRA and President Trump’s Executive Order introducing International Reference Pricing.

A proven, AI-powered safety platform can accelerate adverse event detection and safety data extraction to ease the burden on safety professionals and better protect patients.

With the right Chemistry, Manufacturing & Controls (CMC) consulting services, your organization can excel in early-stage strategizing, accelerate timelines, optimize processes, and reduce costs.

Success demands more than tech — it requires a partner who turns complexity into confidence. See how we blend 25+ years of IRT leadership with flexibility, rapid start-up, and people-powered service.