Medical Writing Services: Insights from a Leading Global Roundtable

In the intricate world of pharmaceutical development, where the stakes are high, deadlines are tight, and precision is non-negotiable, the role of medical writing has never been more crucial. Against this backdrop, our recent Medical Writing Roundtable, co-led by Novo-Nordisk, brought together industry leaders from nine global companies, from EU, US, India and China, to dissect the challenges and opportunities facing medical writing services today.

This gathering of industry leaders illuminated the complexities within the medical writing fraternity, particularly in the context of scaling operations, optimizing outsourcing strategies, embracing technology, and addressing the talent gap. The Medical writing roundtable not only underscored the critical importance of flexibility and expertise in medical writing but also highlighted the need for strategic partnerships and technological integration in an increasingly competitive market.

A Snapshot of the Medical Writing Roundtable

According to the roundtable participants, 65% of companies consider their medical writing functions to be healthy, characterized by compliance, high quality, and timely delivery. However, there is still room for improvement, particularly in optimizing processes and metrics. The right combination of technology and talent is essential to achieving these goals.

The biggest challenges identified by the participants included the complexity of portfolios and the integration of newer data sources, with 71% citing these as significant hurdles. Additionally, 62% of participants pointed to the difficulty of finding and retaining talent, especially in the face of increasingly complex trial designs.

Scaling Up: The Dual Challenge of Numbers and Expertise

One of the central themes of the discussion was the necessity for medical writing companies to scale up their operations effectively. As clinical trials grow in complexity and volume, medical writers must be capable of meeting stringent deadlines while ensuring the highest quality standards. However, scaling up in medical writing is not merely about increasing headcount; it is also about enhancing expertise. The participants emphasized the difficulty of striking the right balance between quantity and quality.

Every six months, medical writing teams should reassess their needs, evaluating the demand for specialized knowledge and the capacity to handle larger projects. Flexibility in scaling up is crucial, as it allows teams to adapt to the dynamic requirements of regulatory medical writing and clinical trials. This adaptability is particularly important in an industry where the ability to quickly mobilize resources can make the difference between meeting deadlines and falling behind.

Outsourcing: Strategic Partnerships and the Global Landscape

Outsourcing has become a cornerstone of the medical writing industry, with companies increasingly relying on external partners to manage the growing demands of regulatory documentation and clinical trial reporting. The roundtable participants agreed that a close eye must be kept on the portfolio of the CROs (Contract Research Organizations) to ensure that they are well-equipped to deliver projects effectively. The ideal CRO partner should possess not only therapeutic area knowledge but also strong leadership and ownership capabilities.

Geographically, Europe, India, and China emerged as key regions for outsourcing medical writing services. Top players in the industry have established robust collaborations with medical writing consultants from the US and India, citing these partnerships as crucial to their success. Leading pharmaceutical companies noted that while finding a strategic partner remains a significant challenge, they have been satisfied with vendors from Europe and India who offer flexibility, quality, and cost-effectiveness.

However, the challenge of finding the right talent persists, particularly when it comes to delivering whole documents or complex modules. Even large pharmaceutical companies face difficulties in sourcing experienced medical writers who can meet their rigorous standards. This talent gap underscores the importance of ongoing education and training within the medical writing community.

Educating Medical Writers: The Need for Continuous Development

The education and development of medical writers were highlighted as critical components of maintaining high standards in the industry. Smaller medical writing agencies, in particular, often struggle with quality control (QC) due to a lack of dedicated QC teams. This can pose significant risks, especially in the context of Phase I studies where the cost is already a challenge, and experienced medical writers are in short supply.

The roundtable participants discussed the importance of continuous professional development for medical writers, emphasizing the need for training programs that focus on both regulatory and scientific writing. As the complexity of clinical trials increases, so too does the need for medical writers who are well-versed in the intricacies of different therapeutic areas and regulatory requirements.

Technology and Automation in Medical Writing

The integration of technology and automation into medical writing processes was a major topic of discussion at the roundtable. With the advent of AI tools like ChatGPT, there is a growing interest in how these technologies can be leveraged to create content from existing information, automate narratives, and streamline SAS programming.

While the participants acknowledged that automation is not the endgame, they recognized it as the beginning of a transformative journey. AI has the potential to significantly enhance efficiency by structuring content and reducing the need for repurposing, thereby allowing medical writers to focus on more complex and creative tasks.

One of the companies at the roundtable shared insights from over 300 AI projects, highlighting the need for efficiency in structuring content while maintaining a focus on high-quality output. The consensus was that the future of medical writing would increasingly involve a blend of human expertise and technological innovation, with AI serving as a tool to augment the role of the medical writer.

Priorities and the Path Forward

The discussion also touched on the top priorities for medical writing teams moving forward. These include process acceleration, efficiency, and effectiveness; portfolio delivery; scalability; and the adoption of technology, particularly automation and AI. The participants agreed that these priorities are essential for maintaining a competitive edge in the medical writing industry.

Powering the Way Ahead with Medical Writing Roundtable

The medical writing roundtable provided invaluable insights into the current state of the industry and the challenges that lie ahead. By focusing on scalability, strategic partnerships, technology, and continuous education, medical writing teams can position themselves to meet the demands of an increasingly complex and competitive market.

As we look to the future, the continued collaboration and sharing of best practices among industry leaders will be essential in shaping the direction of medical writing services. The roundtable discussions have set the stage for ongoing dialogue and innovation, ensuring that medical writing remains at the forefront of the pharmaceutical industry’s efforts to bring life-saving therapies to market.

This is your opportunity to get a pulse on handling medical writing complexities with real-life inputs, enabling you to manage them with increasing dexterity and gain insights that will drive your team's success. Click here to register for the next Medical Writing Roundtable today!