Criterion Edge
Assuring Comprehensive Expertise In Regulatory Writing

Medical and regulatory writing is the confluence of science and art. It mandates a high level of scientific understanding to collate and analyze huge amounts of data and the narrative skill to report the information accurately, all while balancing the demands of diverse stakeholders and global regulatory requirements. The ability to present complex data clearly and communicate the desired message into submission-ready and reviewable information is no easy feat.

This is where Criterion Edge’s (CE) team of specialized medical writers fits the bill perfectly.Comprised of a team with decades of writing experience in the space, CE understands that companies often lack the resources—time, people, and expertise— to analyze and present scientific data effectively, meet complex global regulatory reporting requirements and comply with the new EU MDR and IVDR regulations. They also cannot quickly or effectively access published data across multiple databases to drive internal initiatives and data-driven decisions.

“CE’s experienced writing team serves clients who are in need of either bandwidth or expertise in regulatory documentation and scientific report writing. Our writing services are offered to clients utilizing a team model approach, which allows for customization while ensuring cost-efficiency and flexibility to meet clients’ project needs and timelines,” explains Laurie Mitchell, President, CE.

Where Quality, Efficiency, and Collaboration Meet

Instead of providing writing services using the typical staffing company model that utilizes a single writer / single project approach, CE offers clients the expertise of a full team of experts. The company has a dedicated systematic literature review (SLR) team headed by experienced medical and scientific librarians with the skills necessary to perform specific literature searches for their clients. The team can deliver methodologically
robust search services as well as literature screening and data extraction to support regulatory writing.

CE also extends their services to offer guidance on how to analyze, organize, and present data most effectively. They collaborate as a strategic partner that embeds within a client’s organization to facilitate institutional knowledge, coordination, planning, and the development of their critical clinical and regulatory documents.

These services are supported by CE’s capable project teams that include project managers to supervise key components like strategic messaging, data analysis, and conclusions for making sure a project sticks to the timeline and budget.

The project manager is in constant communication with clients and holistically addresses their requirements. In addition, a bench of writers, systematic literature review screeners, medical librarians, and the QC professionals support the team. More importantly, to improve the processes and the quality of the deliverables, CE constantly offers best-in-class training programs for their writers.

A Process-Driven Approach at the Core

To ensure all its services align with clients’ requirements, CE follows a process-driven approach. It all starts with project scoping, where both the teams outline the role, responsibilities, and template for the entire process. This is followed by the documentation of all the inputs collected in the previous step into a highly complex report form. All the processes involved in the various stages of onboarding are very human-centric and labor-intensive. More importantly, clients are always kept in the loop at every stage for their input and feedback.

CE has been at the forefront as a key partner in accelerating the growth of both small biotech startups and large medical device and pharma manufacturers across the globe. For example, in March, the company engaged with a global pharmaceutical giant to write three regulatory reports with delivery dates scheduled for mid-Q3. An internal analysis by the sponsor also identified nine additional reports that needed major updates before the audit, but it was impeded by the serious deficit of resources.

The client approached CE to complete the urgent task at hand. Given the short notice, an expanded team of experienced CE writers was identified. A project scoping exercise was also conducted in collaboration with the sponsor project team to evaluate the project requirements. The CE team worked in liaison with the client throughout the five-month duration of the project cadence. The outcome of the project was impressive, to say the least—with all the 12 reports written, QC’d, and delivered on time to the client’s satisfaction. The scheduled audit was completed with no major audit findings noted.

Fostering Long-Term Relationships through Client Partnership

Successful client partnerships like this have helped CE foster long-term relationships with some of the global medical device and IVD companies. Their association with a leading medical device manufacturer allowed CE to be at the frontline of early MDR-compliant reporting and responses. For instance, they were the primary author of one of the first Clinical Evaluation Reports submitted for notified body review under the new EU MDR requirements.

Going forward, CE’s primary goal is to expand into the In Vitro Device (IVD) space. IVD companies can leverage CE’s project experience with EU MDR compliance to support and even fast-track their compliance with IVDR requirements. The company also plans to enhance the reach of their SLR services across markets. They are further expanding the writing services into other channels, like Health Economics and Outcomes Research (HEOR) writing, clinical marketing writing, as well as regulatory and medical affairs consulting and support. “We are more than writers. We are consultants, analysts, and scientists with the skills needed to produce high-quality results,” says Mitchell.