A pharma major requested for authoring LSP and LSR.

Challenges:

• Client did not have process documents.
• There is no standard template provided by the regulators.
• Client requested for a layman review.

Delivery Approach:

• We used in-house templates to author the documents.
• In-house process was followed.
• Graphic designers helped to create infographics.
• As layman review is part of the process, the client request was fulfilled.

Future Prospects:

• Client has also requested for PLS authoring, thus providing end-to-end lay summary services.
• Lay summary services along with the protocol registration and results posting will provide a one-stop shop for transparency requirements.