Transparency in clinical development has been progressively formalised in legislation that requires data to be made publicly available in the form of lay summaries, data registries and redacted submission documents (including the Clinical Study Report, Clinical Summary and Clinical Overview).
While the information that is either commercially sensitive or might identify individual patients may be redacted in the public documents, this content must be agreed in advance with the appropriate authority, and achieving the right balance can be complex.
Insight is well placed to support and facilitate your data transparency obligations. We are proficient at preparing lay summaries, ensuring that often complex concepts are explained in a clear and easily accessible manner.
Our writers have also been trained on the new redaction requirements and ensure a proactive approach is taken from the first draft, pre-empting and minimising the need for later efforts. In addition, our redaction specialists focus on tools, techniques and procedures that facilitate identification and justification of information to be redacted.
You can ask any questions to our clinical trial experts by sending your queries to firstname.lastname@example.org. Our clinical trial team will review and provide feedback within 72 hours.