The Key to Exceptional Medical Writing Services
Introduction
People and processes are the bedrock of success for any service provider. Without good people, processes are useless, but without solid and standardized processes, even the best people can struggle. This is especially true in medical writing. Even the most talented, experienced, and dedicated writers need Standard Operating Procedures (SOPs), templates, style guides, and guidance.
For projects to succeed, project management teams must follow standardized processes for reporting, budgeting, timelines, and more. Sponsors need clearly outlined review processes to ensure comment resolution meetings are valuable and timelines are met. Combining refined processes with best-in-class writers and project managers allows for excellence in every aspect of project delivery, from setup and kick-off meetings to document drafting and finalization. Our ‘processes’ enable our ‘people’ to deliver high-quality medical writing every time, ensuring seamless project delivery.
People – The Core of Every Project
Medical Writers
Our medical writers are the heart of our projects. Their individual expertise, regulatory knowledge, and understanding of project nuances is what makes them exceptional. By combining therapeutic area and document experience with leadership, strategic input, and excellent communication skills, our writers provide genuine value to every project they work on. Their soft skills and dedication result in a partnership built on trust and communication, while documents are crafted with precision and clarity. Clients can be confident they will receive a high-quality final draft that’s on time and meets their crucial deadlines.
Project Management Team
Our project management team plays a crucial role in making sure our writers can focus on what they do best. Each project is assigned a dedicated project manager who serves as the main point of contact throughout projects. From in-depth reporting on project progress, timelines, and budgets to the organization of strategic and ad-hoc meetings, our project managers ensure everyone is aligned on expectations, roles, and responsibilities.
This single point of contact removes the need for biotech teams to worry about project resourcing and ensures seamless communication between writers, clients, and review teams. With years of experience working with biotech and pharma, our project managers excel in coordinating high-quality medical writing projects and their proactive approach ensures that any risks are identified and mitigated early. By taking the time to understand the unique requirements of every project, we build out a tailored team of writers, QC specialists, and publishing specialists, all prepared for success.
Processes – The Backbone of Excellence
Streamlined Workflows
Streamlined workflows and standardized processes form the backbone of our medical writing processes. These include SOPs, Work Instructions, document checklists, style guides, and templates. These underlying processes provide a basis for our medical writers to excel, ensuring consistency, efficiency, and quality.
Imagine a small biotech running its first clinical trial, needing to develop its first protocol, CSR, and major IB update. They may not have the time or resources to develop these documents in-house, let alone the templates and processes to guide them. With Morula Health, this is not a problem. Some clients have their own, internal processes they prefer to follow, and our writers adapt to these, ensuring documents, language, structure, and key messages align with client preferences and pre-existing related documents. Consistency is crucial for document quality. Without clear processes, medical writing can become chaotic and inconsistent, leading to more amendments, rejections, and delays.
Project Delivery Structure
Processes extend beyond documents; project delivery must follow a predefined structure to avoid rounds of review spiraling out of control. From the early stages of project discussions, our project management team uses Asana to clearly outline timelines and project structure, with meetings, drafts, reviews, QC, and finalization all planned to the day. As standard, documents are developed with only 2 rounds of review, and a formal Quality Control is performed on the final draft.
Timelines can be impacted by many factors, so using Asana allows our team to quickly and transparently update project timelines to align with new information or deadlines. A clear, visual representation of workloads is crucial to ensure everyone is on the same page. This is even more important during projects with several writers and various documents – using Asana ensures tasks are completed in a logical order and client review times don’t overlap, maintaining efficiency.
See the example of how we used Asana to manage multiple ongoing projects for a European biotech client and a team of experienced medical writers to work cohesively:
Efficient and Transparent Management
Document-related processes and project management tools ensure drafts are high-quality, consistent, and on-time. Meanwhile, efficient tracking and transparent communication of project updates, budgets/invoicing, and wider resourcing requirements are essential for a successful partnership.
Weekly project reports outline budget progress, hours used, key milestones, timelines, and next steps. These are key, non-negotiable processes we follow for every project, whether it’s a manuscript, an IB update, or a full NDA submission. Project closure processes include final reports, invoices, closure of SharePoints/return of files, etc., each of which is completed in line with our internal SOPs that have been standardized and refined over time based on client feedback.
In the fast-paced environment of biotech, sticking to clear and effective processes is fundamental for successful medical writing.
What Sets Us Apart
At Morula Health, we go beyond just meeting deadlines and delivering high-quality documents. This should be non-negotiable. We have recently started implementing AI tools, mainly Microsoft Copilot, to make our internal processes more efficient. For example, we transcribe kick-off meetings and comment resolution meetings (with the permission of our clients) and use Copilot to produce summaries of key discussion points and action items. This enables our project team to be fully engaged without having to worry about taking notes and generates accurate, useful follow-up items for our clients.
Our delivery approach focuses on assigning writers based on their individual project-specific expertise, rather than just whoever happens to be available at the time. Our writers are assigned to projects they are genuinely passionate about and commit to long-term timelines.
In 2024, we completed 100% of projects without having to change or reassign the writer. This means the experience promised to the client was the experience they got, every time, with no exceptions. This 0% turnover is a testament to our dedicated team and our focus on assigning writers based on what matters to our clients.
By combining the strengths of our people with refined processes and innovative tools, we ensure that every project is delivered in line with our clients’, the regulators’, and our own consistently high standards. At Morula Health, our commitment to quality, timely project delivery, and client satisfaction sets us apart in medical writing.