How much of a lawyer should a Contract Manager be (if at all)?

study contracts training at ECCRT

CTA negotiations can be a hurdle for trial initiation

Our top 10 Q&A on Trail Master File

1. What is a Trial Master File (TMF)?

Each clinical trial comes with documentation of trial related activities, legal requirements and trial data. All trial related documents need to be collected, organised, managed and maintained in what is called the “Trial Master File” or Electronic Trial Master File (eTMF).

2. Why is a TMF needed?

A TMF is essential to enable the evaluation of the conduct of the clinical trial, the integrity of the trial data and the compliance with regulatory requirements. A TMF allows reconstruction of the trial activities undertaken, trial decisions made and trial data generated. A TMF is also indispensable to manage the clinical trial as it permits involved individuals to access trial information.

3 Facts about Risk Based Monitoring you need to understand

Risk Based Monitoring training at ECCRT

Risk Based Monitoring is a new approach of study monitoring. This has been first emphasized as a better method to reduce quality issues by FDA in August 2013 and then EMA in November 2013. This approach is now also a requirement from ICH-GCP since November 2016 when the ICH-GCP E6 (R2) has been published.

5 facts you need to know about a CRO

Many biotech companies underestimate the importance of selecting the right CRO: they do not realise that they put their (very often) single asset into the hand of an external party. As a fact, multiple biotech organisations didn't make it simply because they selected the wrong partner for their venture. Here are a few facts we want to share to help you succeed in your collaboration with a CRO.

1. Sites like working with CROs