Ken Keefer

Jul 12, 2024 | clinicalleader.com | Ken Keefer |Pankaj Manon |Dan Schell

Right-sized for biotech successIt’s not the size of your company. It’s the size of your passion and your dedication to improving patients’ lives that IQVIA Biotech is uniquely built to serve. There is nothing bigger to us than your success. We’ve got you. Defining Critical Elements For TMF Quality In ICH E6(R3)By applying Quality by Design to clinical trials, sponsor companies can rise to meet the elevated role and importance of the TMF in the face of ICH E6 (RF3).

Apr 9, 2024 | clinicalleader.com | Ken Keefer

By Ken Keefer, MBA, PMP, Keefer Consulting Inc. eTMF technology has made significant strides in gathering and managing large amounts of clinical trial content from internal systems, partners, and service providers worldwide. Yet inefficiencies persist despite this progress and the efforts of sponsors to keep content flowing into the TMF while maintaining its quality.

Dec 12, 2023 | clinicalleader.com | Ken Keefer

By Ken Keefer, MBA, PMP, Keefer Consulting Inc. Could your director of clinical operations or TMF manager identify all customers of the TMF? Perhaps they would first name the regulators who inspect your TMF when confirming GCP compliance? Meeting the needs of regulators is critical. Inspection-readiness is an essential objective in TMF planning. Regulators are customers external to the sponsor organization, as are providers, patients, and payers.

Jul 17, 2023 | clinicalleader.com | Ken Keefer

Get more clinical research insight with our FREE newsletter sign me up Trial Design Partnering Clinical Technologies Regulatory Market Research Clinical Leader Live Guest Column | July 17, 2023 By Ken Keefer, MBA, PMP, Keefer Consulting Inc.

May 30, 2023 | clinicalleader.com | Ken Keefer |William Tamulynas |Rinah Yamamoto |Doug Pierce

You're receiving the Tuesday edition of the Clinical Leader newsletter, focusing on Clinical Trial Technology. To make changes to your newsletter selections, update your topic preferences. Clinical Sites | Patient Centricity | Patient Recruitment (Monday) Clinical Trial Technology (Tuesday) Decentralized Trials | Trial Management (Wednesday) Outsourcing Models | Regulatory & Compliance (Thursday) (Friday)Learn more about our personalized newsletters here.