Quality. Knowledge. Ownership.
When it comes to data services, crunching the numbers is table stakes. Data management, programming, statistical analysis, reporting, and more all make up the clinical trial data lifecycle, and they all need to work in concert to deliver the insight sponsors require. As such, a data services partner can either help or hinder the speed and success of clinical trials.
Firma is a collaborating consultant partner rather than just a contractor—a key difference that is especially critical for small and medium-sized companies but is also appreciated by large ones.
What makes Firma data services different can be distilled into three characteristics: ownership, quality, and knowledge. Here’s how these broad approaches manifest themselves in every engagement we enter.
Firma accepts shared ownership of every project we undertake, entering each engagement as a partner on the clinical trials, not just a vendor. Since we have provided data support for 61 successful major regulatory submissions, we have seen (and solved) many of the issues that can arise. We’re also experienced in rescuing studies that are struggling with data quality or experiencing timeline issues—including major regulatory submissions.
That experience allows us to proactively identify red flags and then bring solutions to the table, providing hierarchically-ordered suggestions to our clients for any study issues—or opportunities.
For example, Firma worked on a blinded study for an infectious disease indication. Because of COVID-19, about 1/5 of the patients were missing follow-up data that were a part of the primary endpoint. In addition to suggesting the sponsor notify the FDA, Firma’s project statistician also modified the Statistical Analysis Plan (SAP) by including a new section, “Missing data handing due to COVID-19,” and added several new approaches to impute these missing data as sensitivity analyses.
This modified SAP was sent to FDA for review and signed off prior to database lock and treatment unblinding. When the study analysis was performed, all of these different approaches gave highly similar results, proving the robustness of the treatment effect.
Firma follows its extensive quality procedures strictly so sponsors can rely on the data in the tables and figures—the first time. When a client sends out a press release, we want them to be confident in the conclusions they have drawn.
To that end, we combine statistical analyses with extensive clinical expertise and state-of-the-art data management procedures to reach the highest quality deliverables by the shortest route possible for both accuracy and speed.
The Firma team’s extensive knowledge of three leading EDC systems (Rave, Medrio, and Inform) means we can choose a system that best meets the needs of each project, resulting in a quicker database build. And data managers are trained to perform cross-module data reviews using our proprietary SAS programs—a critical quality step that is not possible within standard EDC systems. We can even perform MedDRA and WHO coding outside of EDC systems which is often more efficient, saving our clients time while also ensuring high-quality results. This ability also saves our clients money since they can avoid purchasing a coding module from the EDC vendor.
All statistical programs for tables, figures, and listings are independently double programmed. A primary programmer and a validator work at the same time and then check their results against each other, comparing the results to confirm alignment. Before Firma sends outputs to clients, we gather the entire team for a detailed review meeting that includes extensive scrutiny of every aspect of the outputs.
The Firma team never failed to deliver on time and with high quality even when supporting global regulatory submissions in Japan and Europe. Their post-submission support to respond to regulatory queries is unparalleled, as timeliness and accuracy is key to approval.
~ Director of Biostatistics at a global life sciences corporation
Technical & Clinical Expertise
Rapid drug approval and device clearance with favorable labeling require a compelling, easily understood data story sponsors can present to the FDA. That’s why Firma’s technical staff are highly educated, with either master’s or PhD degrees, highly experienced, and highly trained.
Every team member receives training on the medical aspects of their studies as well as statistical methodologies, so they have the tools to address many types of problems that staff without such clinical training might not detect or be able to fix.
Such training has led to unexpected beneficial solutions for our clients. For example, while performing role-playing exercises on a study in progress, one of our biostatisticians noticed patients with a particular baseline characteristic appeared to be receiving more benefit from the antibiotic being studied.
We reported the finding back to our client and it created a second, pivotal study that stratified the patients by categories of this baseline characteristic. The results from that study? Our observation bore fruit and allowed the client to create a more nuanced and detailed understanding of appropriate indication for the drug in question.
In short, we know how to draw the clinical relevance from your data.
Firma’s extensive regulatory submission experience means our technical team has a deep understanding of many different indications and has faced and conquered many types of data challenges. When knotty statistical issues arise, our experts perform extensive literature searches to come up with the best solutions.
Firma has been the best biostatistical and programming vendor I have worked with so far. When they agree to a timeline, they deliver, and the team members are all very responsive—even for urgent support requests. Everyone on the team is experienced and skilled in both programming and statistics. As an example, they have delivered quite a few high quality and difficult-to-program figures to us.
~ Director of Biostatistics at a large biopharmaceutical company
Getting clinical trial data cleaned, packaged, and processed faster than the industry expects gives our clients an advantage. That’s why we always balance accuracy and speed.
As experienced rescuers, Firma has seen (and saved) Phase 3 and major regulatory submissions that have gone sideways. While poor quality deliverables are sometimes the problem, delayed timelines are more often than not the primary reason a study is in crisis—usually due to a lack of experience or independence on the vendor’s part. Few things slow a clinical trial down more than a vendor that requires heavy-handed oversight.
At Firma, we take timelines as commitments, not as suggestions, and are known for both being available and working as needed to meet promised deadlines. Because we don’t believe our mission is just to crunch the numbers. We believe in the power of what we are doing to save lives and improve people’s quality of life.