White Papers

External Controls In Clinical Research, Part 1: The Clinical Imperative

Clinical Research

External controls white paper cover

In the following white paper, Worldwide Clinical Trials’ chief medical and scientific officer, Michael Murphy, M.D., Ph.D., and assistant director, clinical research methodology, William Slone, Ph.D., discuss when, how, and whether to factor external controls into a program.

White Papers

Ensuring Access and Approval for Innovative Therapies in Scleroderma

Immunology

Ensuring Access and Approval for Innovative Therapies in Scleroderma

Clinical research and development programs for innovative therapies in scleroderma must accommodate the diverse data needs of multiple stakeholders. This white paper explores the requirements to create an integrated program capable of demonstrating the “value” of a new product, as well as clinical utility and therapeutic novelty.

White Papers

Pharmacy Services in a Phase I Clinical Research Unit

Early Phase

Worldwide - Pharmacy Services in a Phase I Clinical Research

Phase I clinical studies form an important foundation for drug development and eventual approval of life-saving therapies. Potential drug candidates are screened for entry into Phase I trials by extensive in-vitro testing and tolerance in several animal species. This article explores the inner workings of a highly active pharmacy in a modern Phase I clinical research unit (CRU).

White Papers

Five Emerging Trends Within Cardiovascular Research

Cardiovascular, Clinical Research

Worldwide Clinical Trials - Five Emerging Trends Within Cardiovascular Research - White paper

Five emerging trends within the drug discovery/drug development paradigm are highlighted in this review—each reinforcing the need for therapeutically focused, methodologically rigorous, and highly efficient project teams for product evaluation and commercialization.