Drug Development Smart Strategies:  1. Partnerability:Partnering is a core element for most Biotech business models. Partnering at the optimal point of their asset. Optimal Point is defined by proactively updating when new information arrives:Scientific read-outCompetitive LandscapeRecent dealsRegulatory decisionsetc

CTA negotiations can be a hurdle for trial initiation The amount of clinical trial agreements (CTAs) that a “contract manager” or a “project manager” (or any other name used within a company to identify a non-legally trained person in charge of the coordination of CTA negotiation and implementation) must handle for one single clinical study is generally

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

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. This new approach

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

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