Achieving Patient Centricity in Clinical Trials: Uncovering the Mystery

Clinical Researcher—November 2018 (Volume 32, Issue 9) RECRUITMENT & RETENTION Rosamund Round, MSc; Kate Williams, MSc, PhD   Patient centricity has been deemed something of a buzz phrase within the pharmaceutical industry in recent years. Some see it as the key to commercial success, others as being at the heart of an ethical approach to […]

EU Regulatory Y2K: Objects in Mirror Are Closer Than They Appear

Clinical Researcher—November 2018 (Volume 32, Issue 9) DEVICES TODAY Adam Steadman   Every manufacturer and distributor of medical devices in the European Union (EU) and other countries that use the CE marking as the primary medical device certification pathway is aware that changes are coming to the European regulations. Specifically, everyone awaits the implementations of […]

Kristen Bennett, Associate Director for Client Delivery, The Avoca Group

Weak Trial Protocols Make Sites Feel Doomed to Fail

“Maybe this sounds a little emotional,” says Kristen Bennett, associate director for client delivery at The Avoca Group, Inc., a life sciences consulting firm, “but I think we have to take all of this to heart, to see how we can improve running clinical trials [by] keeping in mind why we do it [and] never […]

Dorozinsky Headshot

Inspection Readiness Begins with the Trial Master File (TMF)

PAID MESSAGE - The Trial Master File (TMF) is held by the sponsor and represents the story of the study of the study. The Investigator Site File (ISF) is held by the site and represents the story of the study at the site. These documents are the cornerstone of inspection readiness, and it is essential […]

Turning a Chapter in the Quest for Education and Networking

Long-time ACRP members are well aware of the many opportunities available for learning and networking through the Association’s annual meeting. For those who need to maintain their certifications, attending each year is an efficient method of gaining contact hours toward doing so. Sometimes however, circumstances of timing, location, and employer reimbursement for the meeting […]