Insights

  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...

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...

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 #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 #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...