Crafting an Investigator’s Brochure for a biopharmaceutical company

Dr Euan Paterson

Client

A biopharmaceutical company with clinical development teams in the United States and Europe.

Challenge

Author an Investigator’s Brochure (IB) for a new indication.
Provide content guidance.
Liaise and coordinate with authors across groups and time zones.
Adapt the document to the changing needs of the client.
Adapt the document to accommodate a change in document strategy.
Incorporate newly available data close to the document deadline.

Approach

Using Alchemy’s internal IB content template, in conformity with ICH E6 (R2) requirements to inform the structure and content, a draft IB was produced and updated as the client’s needs changed.
Regular calls were scheduled with the client’s team to discuss the progress of the IB and ensure the client’s needs and expectations were met.
Alchemy provided strategic guidance on content requirements to ensure key clinical and non-clinical messaging and data were included, and that the document complied with regulatory requirements.
Alchemy provided a flexible authoring approach that accommodated the client’s evolving strategy and direction.
The Alchemy team liaised directly with the large cross‑functional authorship group to successfully ensure all required information for the reviews and delivery were obtained in a timely fashion.
Formal review rounds and comment resolution meetings were arranged to gather feedback, resolve outstanding comments and queries, and ensure all updates were captured and applied.
Alchemy provided a full quality control review of the content and formatting prior to document finalisation.

Result

A high-quality IB was produced, within the client’s required timeframe, meeting the client’s complex evolving needs and incoming data.

Thank you again for your committed, gracious, and scholarly work… I know it was no easy feat to create this (impressive) new version of the IB… and integrate all of the relevant data to support the… indication and clinical trial. The… team is incredibly grateful for your hard work to meet the submission deadline. THANK YOU!!!