timelapse33 – myClin

TMF Management & Good Trial Operations are Indivisible

timelapse33Aug 16, 2019 Clinical Oversight, Events No Comments

TMF Management & Good Trial Operations are Indivisible

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

How Will You Be Inspection Ready Next Time? (Part 3)

timelapse33Jul 09, 2019 Clinical Oversight, Events No Comments

How Will You Be Inspection Ready Next Time? (Part 3)

Clinical Oversight, Events

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

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

timelapse33Jul 09, 2019 Clinical Oversight, Events No Comments

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

Clinical Oversight, Events

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

timelapse33Jun 18, 2019 Clinical Oversight, Events No Comments

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

Clinical Oversight, Events

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

Reflecting on 3rd EU Clinical Quality Oversight Forum

timelapse33Jun 04, 2019 Clinical Oversight, Events No Comments

Reflecting on 3rd EU Clinical Quality Oversight Forum

Clinical Oversight, Events

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

Oversight – Going Mainstream?

timelapse33May 28, 2019 Clinical Oversight No Comments

Oversight – Going Mainstream?

Clinical Oversight

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

5 Tips for Planning an Investigator Meeting

timelapse33Apr 09, 2019 Events, Investigator Meeting, Site Management No Comments

5 Tips for Planning an Investigator Meeting

Events, Investigator Meeting, Site Management

By Valerie Crossley, Office Associate & Project Manager at myClin 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....

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

timelapse33Jan 18, 2019 Clinical Oversight No Comments

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

Clinical Oversight

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

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)

Clinical Oversight

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...