Experience is an important metric for qualifying and selecting outsourcing partners for biotech and pharma, regardless of whether it is full-service outsourcing or medical writing services.
Readers of RFIs/RFPs will be familiar with experience-related statements such as 25 oncology medical writing projects in the last five years, 15 medical writers with relevant neurology experience, 18 rare disease CSRs written in the previous five years. The list goes on…
The experience described here is corporate. Unfortunately, this sometimes does not result in a project team with comparable experience, which can be frustrating and impact the quality of the service.
At Morula Health we deliver experience to our customers in two ways:
Firstly, there is the project team experience. No project is the same, and the experience required varies depending on the project and customer. We identify medical writers from our network who are the best fit for our customer’s projects based on their experience in a therapy area/indication, drug type, and specific document, as well as availability and geographic location. Regardless of the processes, technology, and training in place, it is impossible to replace experience built up over many years.
For example, when writing the CSR for a Phase 3 non-small cell lung cancer PD-1 inhibitor trial, we identify and assign a writer with experience writing CSRs for biologic solid tumor studies. Their experience writing similar documents and reviewing similar data enables them to interpret and report the clinical trial data to a high standard.
Secondly, we present our operational experience - our processes and technology transferable to any project with any customer. We consistently review, challenge, and improve the way we deliver projects.
For example, there can be a lot of wasted time if you start writing patient narratives before database lock, yet sometimes a necessary task if there are many to be written in a short period of time. To overcome this, we program our automation software with the dataset and template. Then perform a dry run with dummy data on a small number of narratives to be approved by the customer. With this information we can estimate the percentage of each narrative that can be automated and the percentage that requires the input of an experienced medical writer, ensuring an accurate estimate of time and budget for the completion of the project.
Once the database is locked, we run all the narratives through the automation software, and then our medical writers complete the remaining sections. Our QC process involves both medical writers and software. We continually refine and add programmable QC checks into our software system to aid our team with this vital process. It is a highly efficient and quality maximizing strategy for writing many patient narratives, a process that has been reviewed and adapted over time.
Morula Health is a new kind of medical writing partner. We combine our operational experience with our expert medical writers to be the experienced outsourcing partner customers are looking for, bespoke to each customer’s needs.
If you would like to learn more about how we can accelerate your clinical trial with our medical writing services, please get in touch - info@morulahealth.com