Overcome the unique challenges of late-phase product development and generate the right data to support your products' objective. Products in late-phase development have complex needs and demands. Programs at this phase support new indications, value communication, adherence strategies, safety and efficacy and more.

Clinical trials are becoming increasingly complex and competitive, so attracting the best investigator sites to participate in a trial is a crucial step in meeting patient enrollment targets. Learn more about how investigator preference can help meet trial recruitment milestones.

Experience a new solution for lab and biomarker data management designed around you.

This paper focuses on pharmacovigilance (PV) and risk management for biosimilars, the issues and challenges faced in monitoring their safety and possible solutions.

This white paper discusses the value of planning potency assays early in the clinical development process, explains some of the barriers to potency assay development and regulatory acceptance and provides some top tips on how to overcome potential hurdles.

In this installment of his column in Bioanalysis Zone, Robert MacNeill explores hydrophilic-interaction liquid chromatography (HILIC) and how the technique is often overlooked.

This white paper discusses current challenges of traditional clinical trials, the emergence of eClinical applications and microservices that can enable virtual trials, barriers to adoption of innovative study delivery models and the role of contract research organizations (CROs) in partnering with biopharma to unlock the benefits of virtual trials and maxi

A large pharmaceutical company wanted to employ central monitoring for their entire inhouse portfolio of approximately 50 studies. Study startup and management was retained by the sponsor and another CRO was assigned to perform on-site monitoring.

SETAC Europe 2020 -- Nanomaterials are an area of increasing scrutiny in a regulatory environment, with regulatory frameworks in development for multiple countries such as the EU, US and Canada. Recently, a specific revision of the REACH information requirements for nanomaterials has been adopted by the European Commission.

SETAC Europe 2020 -- Algae are internationally established test organisms in chemical risk assessment. Toxicity test guidelines incorporating algae are largely focused on traditional apical endpoints such as growth rates following a 72-hr chemical exposure as per OECD 201 guidelines.