Back to Kinapse blog Kinapse welcomes you to ICH Q12 The key milestone is reached with adoption (Step 4 of ICH process) of ICH Q12 Guideline on the Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. On 4th December, ICH published [...]
Kinapse launches Plain Language Summary Portal Kinapse, a Syneos Health Company, a market leader in clinical trial disclosure services, announced the launch of ClinTrialDataShare.com, a web portal for sponsors to publicly share plain language summaries (layperson summaries, lay summaries, or results summaries) of clinical trials. With the aim to improve transparency of clinical [...]
Learn why requirements for plain-language summaries of clinical studies, aimed at a broad, non-technical audience, could create new risks for sponsors.
With the UK set to leave the EU in the near future, Kinapse examines the potential implications for the EU QPPV