On-demand Medical Writing solution to enhance capacity during peak workloads

A mid-sized, global biopharmaceutical company specialising in rare diseases and neurodegenerative disorders,
including ALS and Parkinson’s, needed a scalable cost-effective solution to manage periodic surges in medical
writing demand. The company maintains a global workforce of over 5,000 employees and utilises an embedded
ICON FSP medical writing team of five to support its portfolio. During high intensity periods, however, the client
sought a cost-effective, rapid response model to augment capacity without adding permanent headcount.

The client encountered highly concentrated peaks in narrative writing needs, particularly during critical phases of clinical development. Tasks such as patient narrative drafting are predictable in timing but can require significant effort, specialised therapeutic knowledge, and rapid turnaround. 

This challenge intensified when a key NDA submission required three clinical study reports (CSRs) to be produced in quick succession, each containing a substantial number of new and updated narratives. With the FSP team already at full capacity supporting multiple deliverables, the client needed a fast, flexible, and expertly managed on-demand solution to deliver narrative support without burdening internal teams or compromising timelines.

ICON deployed a customised On-demand Medical Writing model designed to seamlessly integrate with the existing FSP structure. This flexible model enabled ICON to quickly scale resources while leveraging the
FSP team’s deep understanding of client systems, processes, templates, and expectations.

Key elements of the solution included:

• Rapid onboarding and integration: FSP team members onboarded and oriented on-demand writers,
  ensuring immediate productivity with no lift required from client resources.
• Robust project ownership: The FSP Lead managed all aspects of project setup and delivery—timelines,
  workflows, internal reviews, QC, and communication with safety and clinical stakeholders.
• Secure, compliant document management: ICON coordinated all source document transfers and
  ensured deliverables aligned with predefined format, content, and quality requirements.
• Budget management discipline: The team maintained strict oversight of hours and scope to deliver
  within agreed cost parameters.

The On‑demand model was implemented successfully across all 3 studies, leveraging the expertise of the FSP team to ensure expedited execution and completion of all deliverables on time or early.

Study 1: 46 new and 13 updated narratives delivered on accelerated
timelines, over holidays

Study 2 (largest volume):

• Seamless onboarding of additional writers to support
  increased volume
• 110 new narratives delivered on time
• ~5% cost savings

Study 3:

• 48 new and 28 updated narratives completed
• Optimised workflows enabled delivery in <50% of planned time
• ~56% cost savings

ICON’s On-demand Medical Writing model delivered exactly what the client needed: rapid scalability, seamless
integration, and high quality outputs under intense timelines. By pairing the deep expertise of the embedded FSP
team with agile surge capacity, ICON ensured continuity, accelerated delivery, and meaningful cost efficiencies.
This approach allowed the client to navigate high pressure submission periods with confidence—demonstrating
how ICON’s flexible, high performance medical writing solutions empower sponsors to manage workload peaks
without operational strain.