05.15.25 -- EMA Issues Draft Reflection Paper On Accelerating Biosimilar Approval

While compassionate use and expanded access programs provide lifesaving treatments outside clinical trials, the lack of structured protocols can lead to inconsistent data, compromising crucial evaluations.

Ensure compliance with the EU Data Quality Framework for medicines regulation by using this checklist or consulting with experts for personalized guidance to refine your data quality strategies.

Real-world evidence (RWE) is transforming clinical trials by enabling the use of external control arms (ECAs), which serve as an alternative to traditional randomized control groups.

Explore how a vendor that offers integrated drug substance, drug product, and clinical testing activities under one organization facilitates improved communication and a more agile approach to development.

Whether it’s accelerating market entry with the “FSP Country in a Box” solution or maintaining global compliance through expert oversight, IQVIA empowers organizations with scalable, localized support.

Numerous factors impact a drug safety program, but proper management of three key elements drives success while creating a scalable drug safety model.

Learn how CDMOs can drive transformation in the supply chain and create a more sustainable future for the pharmaceutical manufacturing industry.

Choosing the right CRO/CDMO for your first-in-human (FIH) trials enables you to run a successful study that generates high-quality data with speed and ease.

From assistance with time-consuming international documentation through destruction following all regulatory protocols, RPS is your trusted clinical trial partner.