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ICH GCP E6(R3) brings major updates to clinical trial standards. From tech integration to participant protection, the changes are wide-ranging. Our PharmaTimes article shows how a strong impact assessment can guide your ...

From risk-based quality management to tech integration - ICH GCP E6(R3) changes everything. Our article in PharmaTimes outlines how a robust impact assessment sets the foundation for successful implementation. Start smar...

Early phase trials in neurodegenerative diseases demand thoughtful design, patient-centricity, and smart biomarker strategies. Join our webinar hosted by ASCPT for a focused discussion on: - Defining target populations a...

Meet us at AASLD, booth #1041 to learn how our deep expertise in imaging-based hepatic biomarkers and global operational support help sponsors optimise trial design and accelerate the delivery of MASH treatments to patie...

Meet us at AASLD, booth \#1041 to learn how our deep expertise in imaging-based hepatic biomarkers and global operational support help sponsors optimise trial design and accelerate the delivery of MASH treatments to pati...

The FDA and other health authorities like the EMA require a well-defined and consistent drug development process and life cycle management plan. CMC is a critical and a ‘first step’ component in the creation of a develop...

Upstream and downstream process, structural characterisation, functional characterisation and processes are all major CMC related steps that need to be considered by emerging and biotech companies early in their developm...

USP compounding may be fast — but is it costing you quality, compliance, and insight? Join our webinar to learn why GMP is the smarter choice for early phase trials. During this session we will discuss: • The differences...

USP compounding may be fast — but is it costing you quality, compliance, and insight? Join our webinar to learn why GMP is the smarter choice for early phase trials. During this session we will discuss: • The differences...

The incidence of chronic disease across APAC is rising. Biosimilars, with their potential to deliver high-quality treatment at lower costs, are well-positioned to meet this need. However, barriers to adoption, both from ...

The Asia-Pacific (APAC) region is quickly becoming a key player in the global biosimilars market. Additionally, as the region’s incidence of chronic disease rises, this is driving demand for more cost-effective treatment...

Pediatric clinical trials have different processes, risks and challenges than adult trials. Identifying those differences is critical but can be difficult, especially if resources are limited. In our on-demand webinar, ...