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Home » Articles posted by schattopadhaya

All articles by Schattopadhaya 

Front and centre: handling complexities of clinical trials

|Angela Berns: Angela Berns has more than 25 years of experience in clinical research. She is currently the director and head of vendor programmes in the clinical quality assurance group at UCB Biosciences. Prior to UCB, Berns worked for six years as manager of the global GCP computer compliance group at Amgen.|Central labs provide kits built specifically for the clinical study.|Sponsor companies need to perform due diligence reviews of potential partners and maintain adequate oversight to comply with GCP regulations.

Sharing is caring: communication among clinical trial companies

|Terry Walsh: Terry Walsh, RPh, MBA, leads the global group for outsourcing for packaging, labelling and distribution of the clinical supply chain and comparator strategy for GlaxoSmithKline. He has just finished his multiyear secondment as the head of the Comparator Network for TransCelerate.|The Comparator Network has made clinical trial drug supply more reliable and secure.|Fostering a culture of trust and information sharing makes it easier for manufacturers to solve problems more quickly.

Hot mess: clinical supply temperature control

|James Krupa: James Krupa is director of clinical supplies at Shire in Lexington, Massachusetts. He is responsible for providing leadership and strategic direction in terms of planning, budget, coordination, scheduling, resources and tracking of global clinical supplies.||IMPs need to be stored in strictly temperature-controlled conditions.