Strategic Resource Outsourcing in Medical Writing: Insights from the 2nd Roundtable

The second Medical Roundtable provided a rich platform for industry leaders to discuss strategies, innovations, and challenges in medical writing outsourcing. There were 11 attendees from across 8 companies, and the discussions emphasized the importance of strategic foresight, technological integration, and the optimal balance between insourcing and outsourcing.

Defining Medical Writing Services

Medical writing, a cornerstone of regulatory and scientific documentation, faces mounting pressure to deliver high-quality, fit-for-purpose content at scale. The roundtable highlighted that organizations could streamline their medical writing strategies by categorizing tasks into core and non-core activities. Non-core documents, such as standardized narratives and routine summaries, can effectively be outsourced to specialized medical writing companies. This division not only enhances operational efficiency but also allows in-house teams to focus on high-value, complex writing projects.

Forecasting emerged as a pivotal theme. High-level predictive models based on historical data can guide resource allocation, ensuring scalability in response to fluctuating demands. Such models enable organizations to pivot between internal and external resources without compromising quality.

In order to understand the extent of support provided by exclusive medical writing agencies, it is important to understand the challenges that exist and how pharma companies, across sizes, deal with these challenges.

Challenges in Medical Writing Outsourcing

Despite the opportunities outsourcing presents, several challenges must be addressed:

• Lack of a Formal Mechanism : Ad hoc approaches to outsourcing often result in misaligned expectations and outcomes.
• Suboptimal Planning and Forecasting : Ineffective resource allocation and an inability to anticipate needs can lead to project delays and inefficiencies.
• Rapidly Changing Requirements : Shifting priorities often leave outsourcing partners scrambling to adapt, causing disruptions in timelines and quality.
• Talent Gaps : The right skills are frequently unavailable when needed, leading to delays or suboptimal outputs.
• Over-Allocation and Burnout : Internal teams often face overwork as they try to fill gaps left by outsourcing shortfalls.
• Insufficient Funds : Budget constraints can prevent organizations from engaging medical writing service or scaling resources effectively.

A Spectrum of Approaches Across Pharma Scales

The roundtable showcased the varying strategies adopted by pharmaceutical companies based on their size and operational focus:

• Large Pharma emphasized the need for globally recognized medical writing services with good digital capabilities. For them, outsourcing is a component of a broader leadership strategy focused on balancing cost efficiency with medical writing capabilities.
• Mid-Sized Pharma, transitioning from 100% in-house models to blended approaches, are leveraging boutique service providers for specialized projects like synopsis creation and submission documentation. Their experiences underscore the criticality of aligning outsourcing decisions with strategic goals.
• Small Pharma highlighted resource reduction and cost containment as primary drivers for outsourcing. Challenges around data sharing, budget management, and leadership alignment were central to their discussions.

One of the key takeaways from the roundtable was the "4Bs" framework—Buy, Borrow, Bot, Build—as a guide to formulating a strong resourcing strategy.

Leveraging the 4Bs for Medical Writing Success

• Buy : Talent acquisition remains the foundation of any resourcing strategy. For high-priority, complex projects requiring domain expertise, recruiting skilled in-house medical writers ensures continuity and quality. Companies were urged to strategically invest in talent that complements their core operations.
• Borrow : Outsourcing emerged as a strategic lever for scalability. Flexible models like Full-Service Outsourcing (FSO), Functional Service Provision (FSP), and delivery-based resourcing allow companies to engage specialized vendors for non-core or routine tasks. Participants emphasized the importance of selecting globally recognized vendors with proven digital capabilities to ensure cost-effectiveness and operational synergy.
• Bot : Automation was discussed as the next frontier for medical writing. AI-powered tools can handle repetitive tasks like data extraction and standard report generation. However, the consensus was clear: AI will not replace humans but will augment their efficiency.
• Build : Upskilling internal teams is critical for sustainable success. Building capabilities involves technical, leadership, and digital skills training. Adopting AI requires a dual focus: 30% on system knowledge and 70% on enabling humans to adapt effectively.

Incorporating Automation and AI Driven Solutions

The integration of automation and AI into medical writing is gaining momentum. Several leading pharma companies shared their progress in piloting AI-driven tools for automating case study reports and generating standardized submissions. However, the consensus was clear: automation in medical writing remains in its infancy. Multiple iterations and incremental learning from study reports are necessary before bots can be seamlessly integrated into end-to-end workflows.

Incorporating AI demands a strategic approach. By blending internal expertise, boutique service providers, and automated tools, companies can create resilient frameworks capable of addressing diverse project requirements. This hybrid model exemplifies the future of resource outsourcing—a symbiotic relationship between human expertise and technological innovation.

The roundtable concluded that the future of medical writing lies in collaboration and adaptability. Whether leveraging insourced talent, engaging medical writing consultants, or integrating AI, the focus must remain on delivering high-quality, scalable, and purpose-driven content. With increasing reliance on forecasting models, process optimization, and digital tools, the pharmaceutical industry is poised to redefine medical writing as a strategic enabler.

Navitas Life Sciences: Premier Medical Writing CRO

Navitas Life Sciences offers comprehensive Medical Writing Services tailored to diverse therapeutic areas, ensuring clients overcome challenges and meet their clinical and regulatory needs with finesse and efficiency.

Medical Writing Experts

Navitas Life Sciences has specialist Medical Writers with diverse qualifications including MBBS, MD, PhD, and M. Pharm. This rich blend of expertise ensures a nuanced approach to meet the unique demands of every project. NLS’s medical writing team has comprehensive understanding of various global regulatory guidelines such as ICH-GCP, FDA, and EMA .

Our commitment to excellence is evident across a spectrum of medical writing services spanning various clinical trial phases, including for Clinical Study Protocols, Patient-Centric Documentation, Investigator Support, Comprehensive Study Reports, Regulatory Medical Writing, Web Synopsis, and more.

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