Building the New myClin Brand

“The secret of change is to focus all of your energy, not on fighting the old, but on building the new.” These words are from a character named Socrates in a book published in the 1980s by Dan Millman (and not from the renowned Greek philosopher!). This seamless and constructive transition from old to new...

Mistake #1: Storing your documents in multiple locations — resulting in not knowing where necessary documents are when they are needed. This is a very common occurrence originating with the source of the documents themselves. The fact is, key documents...

Mistake #2: Untagged, Mislabeled and Misfiled Documents The Addendum in section 8.1 of the ICH E6 (R2) sums up this topic with brevity: “The storage system used during the trial and for archiving (irrespective of the type of media used) should provide...

Mistake #3: Lack of Appropriate Document Controls The path of a document from its origin to its distribution must be known and controlled. It is not a could. It is not a should. Document control is a must for those documents that may be described as regulatory,...

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...

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...

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...

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...

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...

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,...

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...

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...

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...

From our webinar: Uncover Study Compliance Blind Spots with the myClin Compliance Score Compliance Blind Spots Our objective today is to understand the full compliance disposition of your study, to show everybody has the latest information and to track...

The expectations of regulatory inspections are rising – requirements are getting tighter and sponsors are expected to make better use of their systems and data. In our Inspection Perspective: Tales From a Recent FDA Inspection session from the Take...