Insights – Page 2

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

timelapse33Jan 09, 2019 Clinical Oversight No Comments

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

By Adam Wood, VP, Business Development at myClin 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....

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

timelapse33Jan 02, 2019 Clinical Oversight No Comments

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

Clinical Oversight

By Eileen Daniel, SVP, Development Operations at Caelum Biosciences 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...

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

timelapse33Dec 11, 2018 Clinical Oversight No Comments

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

Clinical Oversight

By Eileen Daniel, SVP, Development Operations at Caelum Biosciences 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...

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

timelapse33Dec 11, 2018 Clinical Oversight No Comments

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

Clinical Oversight

By Eileen Daniel, SVP, Development Operations at Caelum Biosciences 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...