How Will You Be Inspection Ready Next Time? (Part 2)

How Will You Be Inspection Ready Next Time? (Part 2)

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...

How Will You Be Inspection Ready Next Time? (Part 1)

How Will You Be Inspection Ready Next Time? (Part 1)

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,...

Reflecting on 3rd EU Clinical Quality Oversight Forum

Reflecting on 3rd EU Clinical Quality Oversight Forum

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...

Oversight – Going Mainstream?

Oversight – Going Mainstream?

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...

5 Tips for Planning an Investigator Meeting

5 Tips for Planning an Investigator Meeting

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...

5 Common Mistakes That Can Derail a Clinical Trial Inspection (Part 5)

5 Common Mistakes That Can Derail a Clinical Trial Inspection (Part 5)

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...

5 Common Mistakes That Can Derail a Clinical Trial Inspection (Part 4)

5 Common Mistakes That Can Derail a Clinical Trial Inspection (Part 4)

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...

5 Common Mistakes That Can Derail a Clinical Trial Inspection (Part 3)

5 Common Mistakes That Can Derail a Clinical Trial Inspection (Part 3)

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,...

5 Common Mistakes That Can Derail a Clinical Trial Inspection (Part 2)

5 Common Mistakes That Can Derail a Clinical Trial Inspection (Part 2)

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...

5 Common Mistakes That Can Derail a Clinical Trial Inspection (Part 1)

5 Common Mistakes That Can Derail a Clinical Trial Inspection (Part 1)

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...