I offer a consultancy service in the rapidly evolving area of clinical trial disclosure:
Advice on Disclosure of Clinical Regulatory Documents
Disclosure of clinical study documents is mandatory: http://tinyurl.com/msn2x2z
As an opinion leader in transparency and disclosure (http://dx.doi.org/10.1186/s41073-016-0009-4) I offer training and guidance in this rapidly evolving and highly complex environment. Services include:
• Training and explanation of the obligation to comply with disclosure requirements
• Gap analysis of existing clinical study SOPs, working procedures and templates
• Action planning with functional leads to plug the gaps
• Provision of selected services to support action-planning including SOP, working procedures and templates revision.
Disclosure-ready Clinical Documents
I support practical disclosure of clinical trial data and documents in the following areas:
• “Smart authored” and redacted CSRs (individual study level) and clinical summary documents (dossier level)
• Clinical trial summary results posting in public registries
• Trial results summaries for the layperson.