Clinical Operations staff typically have a number of pretty effective tools for understanding parts of the compliance picture for their study. These are implicit in the process and system choices that we make when executing a study – and we almost...
While good documentation practices have always been central to GCP and good clinical operations, the emergence of distinct eTMF systems and the related TMF teams, has meant that TMF management itself has to an extent been allowed to morph into something...
Real world perspectives from a clinical site, a sponsor, and a technology vendor. myClin and Clinical Works recently organized the Clinical Innovators Summit (CIS) West Coast 2019 to help clinical trial professionals simplify, unify, and advance Oversight...
Real world perspectives from a clinical site, a sponsor, and a technology vendor. myClin and Clinical Works recently organized the Clinical Innovators Summit (CIS) West Coast 2019 to help clinical trial professionals simplify, unify, and advance Oversight...
Real world perspectives from a clinical site, a sponsor, and a technology vendor. As part of our ongoing series myClin and Clinical Works recently organized the Clinical Innovators Summit (CIS) West Coast 2019 to help clinical trial professionals simplify,...
Once again Kristen Hunter, ExL Events and David Fryrear, Abbvie delivered an engaging and stimulating programme. Thanks both! Here are some personal observations shared in the spirit of collaboration. Inspector Access to the TMF Repeated references...
A fortnight ago I found myself in the lovely Italian city of Milan - attending the "Outsourcing in Clinical Trials - Europe" event organised by Arena International The standout content for me came on the afternoon of Day 1 in a series of...
An Investigator Meeting is a time for everyone involved with a new clinical trial to meet face to face and get familiar with the study, including learning about the roles in the study. This is essential for building and maintaining solid communication...
Mistake #5: Lack of training on what constitutes evidence of Oversight Even in organizations with low staff turnover, a common clinical trial staffing pattern is that the staff who represent a company in an inspection are not the staff who started the...
Mistake #4: Ignoring Oversight Responsibilities in Regards to Trial Communication & Collaboration As a sponsor, it is vital to maintain a level of Oversight towards any trial-related duties or functions. ICH E6 R2 states that, “The sponsor should...