The ProPharma medical writing process is an "author-driven" process that can be modified and customized to meet specific client needs. Our overall goals for each deliverable are to meet timelines, manage challenges, produce a high-quality document, and minimize cost.
At kickoff, the medical writer helps to develop the document timelines, establish team expectations, and document strategy, identify potential risks, and establish a risk management plan if needed. During document development, the medical writer collects study documents, collaborates with the authoring team on document content and quality, and follows the communication plan.
The medical writer manages the document review cycles, including comment incorporation and adjudication in collaboration with the authoring team, ensures timeline integrity, and facilitates quality control (QC) reviews, final document approval, and electronic publishing, as necessary.