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Scheduling and Proposal Writing: The Clinical Study Protocol and Report

Level:
Advanced
Area:
Professional Techniques
Code:
PTA6
Duration:
03:30:00
Workshop profile:
Medical writers working in the contract research organisation or pharmaceutical company environment, as either employees or as freelancers. The workshop will meet the needs of writers often working to tight protocol and study report writing timelines because of inadequate scheduling of the processes leading up to and driving preparation of these documents. This is an ideal forum for writers whose organisations or clients have scope to improve their analysis and reporting processes and procedures.
Objective:
Protocol writing heralds the start of the trial documentation and reporting process; the study report is often the final document prepared by medical writers. Exacting and sometimes unrealistic timelines for deliverable preparation are often agreed without consultation with the medical writer. The workshop discusses the stages before and during preparation of these documents to show how achievable timelines may be scheduled, thereby facilitating good proposal writing. After completing the workshop, participants will understand the stages involved so they can make a valuable contribution to their organisation’s or client’s process improvement activities and are better equipped to manage client expectations with regard to efficient, effective and realistic proposal writing and project scheduling.
Content:
• Bidding and project award process • First steps on contract win and allocation of study • Contract review and confirmation of scope • Communication with client and functional groups • Scheduling • Study protocol: stages of preparation • Clinical study report: stages of preparation • Proposal writing • Business advantages of effective scheduling, influencing the process, and managing expectations