Monthly Archives: August 2015

//August
31 08, 2015

Moving to Electronic Source: What’s in the June 2015 ICH Guidelines?

2016-05-09T12:40:47+00:00

On June 11, 2015, the International Conference on Harmonization released the draft update of Good Clinical Practice guidelines.  The addenda feature important changes affecting investigator oversight, document processes, monitoring plans, and validation (the changes will not be final until November of 2016).  Each of these pulls the tide towards further electronic management of clinical trials. With R2, [...]

Moving to Electronic Source: What’s in the June 2015 ICH Guidelines? 2016-05-09T12:40:47+00:00
9 08, 2015

Making Risk Based Monitoring Real for the Other 50% of Sponsors

2017-06-11T17:36:53+00:00

This year we’ve met with 45 pharmaceutical, biotech, and device sponsors about both risk-based and remote-based monitoring (the combination referred to as RBM), and we’re seeing sponsors migrate to RBM in very different ways. We encountered three main RBM positions: Source: Florence HC industry interviews, 2015 Targeted. 50% have moved to targeted monitoring based on [...]

Making Risk Based Monitoring Real for the Other 50% of Sponsors 2017-06-11T17:36:53+00:00
3 08, 2015

Opposing Views on FDA Complete Response Letters

2016-05-09T17:24:12+00:00

Recently, the British Medical Journal published an analysis on how pharmaceutical companies publicly address Complete Response Letters (CRL) from the FDA, more specifically from the Center for Drug Evaluation and Research (CDER). While the EMA publishes data from refusal assessment reports, the FDA does not fully disclose information with CRLs because of privacy rules around unapproved applications. [...]

Opposing Views on FDA Complete Response Letters 2016-05-09T17:24:12+00:00