Seamless transition to Functional Service Provider for medical writing

The decision to outsource to a Functional Service Provider (FSP) often raises questions of transparency,  control, and quality. How much oversight will we retain? What level of visibility and input will we have in day-to-day operations? How do we safeguard institutional knowledge and ensure business continuity? And, most importantly, how can we maintain the high-quality delivery project teams are used to? 

When a top-20 pharmaceutical company decided to outsource a significant portion of its medical writing portfolio to ICON, the answers to those questions came easily. ICON offered a customised approach that allowed the company to transition smoothly into this new operating model with confidence--without sacrificing control, insight, or quality. And the partnership has been growing steadily stronger for more than eight years. 

The pharmaceutical company made a strategic decision to outsource key operational functions, including medical writing, with a goal of consolidating its outsourcing relationships while maintaining strategic control. 

In selecting ICON as a medical writing partner, the company stressed the priorities of maintaining business continuity and consistent quality, preserving institutional knowledge, and meeting fluctuating workload demands in an efficient and cost-effective manner. 

Meanwhile, as is common with such a transformational shift, the company’s staff met the transition with some hesitation. Employees were understandably cautious about a new working model that might disrupt established work practices and alter their company culture.

ICON recognises that each resourcing solution is unique – every organisation has its own distinctive needs and objectives with specific ways of working within its own culture. This is why ICON never takes a “one size fits all” approach, and this engagement was no different; it was a true partnership from the beginning. Before embarking on a path, ICON worked closely with the client to agree on goals for the relationship, define success for the partnership, and develop a robust change management plan. From the start, ICON took pains to understand, honor, and preserve the culture within the medical writing function. 

ICON’s solution was to welcome all the existing medical writing personnel into ICON’s employment, save for a handful of people to support a key therapeutic area in one specific geography. To ensure a smooth transition, the team remained in place physically, and the organisational structure mirrored what had been existing in the client company. This soft landing was designed to reduce attrition and preserve the team’s institutional knowledge and experience. At the same time, the transitioned medical writing personnel, who now reported to ICON, continued to use the client’s tools, systems, and processes without interruption. In short, ICON adopted the client’s way of working. To support the program and quickly get new staff up to speed, ICON developed a robust onboarding and training program.  

Over time, ICON streamlined this model and implemented innovations to gain efficiencies and cost savings. Enhancements included: 

• Establishing a library of guides documenting processes specific to the client to facilitate efficient onboarding and training
• Expanding resourcing to include lower-cost countries
• Providing flexible and scalable resourcing by bringing in additional ICON medical writing resources when needed for peaks in the workload
• Developing an online tool to streamline resource forecasting and to provide on-demand visibility for the client as to the disposition of each project
• Offloading administrative tasks related to document creation from experienced medical writers to more junior staff
• Creating an authoring toolbar to speed document preparation

Nearly a decade into the partnership, the relationship has not only endured, it has flourished. As trust in ICON’s expertise has deepened, ICON team members have been able to leverage their broad industry experience to deliver insights and efficiencies to continually drive added value for the client. 

On the strength of the positive results ICON has delivered, the client has broadened the scope of the engagement to include new therapeutic areas as well as awarded ICON similar contracts across other business units. The ICON team supporting the partnership has grown from 20 resources to more than 80 today.

As further reflection of the partnership’s success, ICON team members have received dozens of  formal partnership awards from the client in addition to innumerable informal accolades and expressions of appreciation from key stakeholders from across the client’s Clinical and Regulatory groups. One such comment from the client is illustrative of the closeness of the relationship: “After joining our team more than a year ago, and working in a fully remote work environment, our ICON medical writer is universally recognised not as just as a teammate, but as a key player. He has demonstrated leadership in engaging with our highly technical and innovative project, which does not fit any mold within our company. The depth of his understanding is equivalent to our other internal technical stakeholders.”

Over the course of the partnership, the ICON medical writing team has continued to deliver 400 - 500 work products each year (ranging from protocols and amendments to submissions and responses to health authorities) on time, and with the high quality expected. These deliverables have supported nearly 70 marketing applications. 

Following the initial transition to ICON, the team quickly stabilised, and staff retention has remained exceptional, ranging from 93 to 96% over the past 4 years. This impressive retention is a testament to ICON’s fit-for-purpose resourcing approach, which is not only more cost effective for the client, but also  alleviates team members of the more mundane aspects of the job, allowing them to focus on more challenging assignments. The structure not only enhances job satisfaction but also creates more opportunities for professional development. Under this model, team members have progressed from authoring individual documents to taking on roles as medical writing program leads, leading marketing applications, and even advancing into functional management positions. This deliberate focus on growth and opportunity has fostered a highly engaged, high-performing team.

In fact, one ICON medical writer in the partnership recalled his professional growth within this partnership, saying, “In one of my first assignments, I was able to lead a program from the initial synopsis for a registrational protocol all the way through to the marketing applications and ultimate approval of a new drug in multiple countries and regions globally. During this same time, I advanced into a management role and had the privilege of leading a stellar team of medical writers to support the initial and subsequent submissions.”