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Case Study For Lay Summaries
Plain Language Summaries
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.