Project and Submission Management
We are your solution for efficient coordination of document development for regulatory submissions and medical publications.
THE ACUMEN PROJECT MANAGEMENT DIFFERENCE: EXPERTISE AND FLEXIBILITY
Discover how Acumen's expertise and flexibility can drive your project to success.
Managing document and submission timelines can be challenging. No two projects are alike, and rarely do they go exactly as planned. At Acumen, we leverage extensive experience to set your submission up for success from the start, handling contingencies with informed, flexible support tailored to your needs.
Acumen's Project Managers (PMs) are seasoned clinical developers, medical writers, and scientists who understand the intricacies of document development. Our PMs have vast experience working closely with smaller biotech organizations submitting to the FDA or EMA. In collaboration with our partners, we ensure your submission is developed efficiently and meets compliance standards.
We recognize that each organization and development program is unique. Acumen tailors services to meet the specific needs of our clients, whether it's complete oversight of all submission deliverables or document-specific timeline support. Our PMs bring industry experience to move your projects forward with highly organized and efficient processes designed for the unique aspects of document development. They are adept leaders who guide your team through the complexities and nuances of the process.
Our PMs support projects of all sizes, from individual documents to full submissions. We specialize in regulatory submissions, including INDs, BLAs, NDAs, and other agency interactions, as well as full publications support, including abstracts, manuscripts, posters, and conference presentations.
40+ Regulatory Submissions Managed
70+ Sponsors
10,000+ Documents Managed
Successful PM is an Art
When it comes to submissions…
Acumen PM strives to unburden you from the day-to-day logistics of building a regulatory filing, so that you can focus on strategy. Our approach is holistic and hands-on. We know how to organize teams, get projects off the ground, and coordinate the work so that your submission can be successfully filed on time. We'll help you translate big-picture goals into integrated timelines that are grounded on realistic assumptions.
With years of submission experience, our PMs can anticipate bottlenecks and propose solutions to mitigate delays. Armed with innovative timeline management tools, we use custom dashboards, including informed content plan development and reviewers matrices, to keep teams updated and facilitate informed decision making. Our PMs are experts at coordinating and tracking every handoff, from identifying responsibilities for each document and through document reviews to transferring the final files to the publisher. And, they keep the team informed with real-time updates throughout the process.
Flexible, organized, experienced, and efficient.
Technology Makes our PM Better
Acumen PM builds a dedicated workspace in Smartsheet for each project, containing integrated timelines, trackers, reports and customized dashboards. This setup is shared to all team members, allowing for real-time progress and tracking visualizations. Customizable tools include
Key date planners to forecast key submission milestones and filing dates
Reviewer/Approver matrices that integrates responsibilities directly to individual timelines
Reviewer heatmaps to visualize individual workloads and identify bottlenecks
Week-at-a-glance dashboards that show upcoming submission activities and individual assignments
Submission trackers that list the status and projected completion dates, in real time, for each document intended for submission
And many more!
Interested in publications support? Our PMs work hand-in-hand with our proprietary publications planning tools.
