If managed right, the data collection and analysis part of your clinical trial should result in accurate and consistent insight. The data teams at Firma work just as quickly as you do. With flexible engagements including FSP, project-based, strategic consulting and creative partnerships, you always get exactly the support you need.
From study startup to submission, your Firma team collaborates closely with the clinical team to meet or exceed timelines and milestones while maintaining the highest level of compliance.
Submission success depends on the integrity and cleanliness of your data. Get accurate, scientifically sound, high-quality results with flexible data capture and a QA process with QC and double programming.
Advanced data analysis and innovative methodologies are our specialities. But we do standard, too. Our summary analyses always make sense and our deliverables are meaningful and submission-ready.
Ensure your data tells the clearest and most compelling story every time regardless of phase, therapeutic area, size of study, or method of data capture. Firma’s clinical experience means we deliver high-quality and statistically sound data, fast and efficient database integrations, and summary analyses that you can count on for your medical device or diagnostic study.
Access deep biometric expertise and remain responsive to the pipeline. A flexible FSP engagement gives you complete control and a highly trained data team at the ready. It’s our expertise on your team. Find out if FSP outsourcing is right for you.
Expedite trial start with our rapid database build – your choice of platform. We consistently achieve a database build-and-release timeline that is 2x faster than the industry standard. EDC programming decreases the need for add-on electronic data capture modules such as randomization, blinded review, and adjudication modules.
At risk of missing agency submission goals? Firma can implement database builds, program and generate tables, and create study report shells to help studies meet aggressive timelines.
Medical, data management, and biostatistics work together, starting with physician-led protocol training for each project, so you always get cross-functional intelligence. Our PhD- and MS-level professionals adhere to a single set of global standard operating procedures, offering their detailed and extensive knowledge of pharmaceutical development to benefit your entire data management and biostatistics planning, execution, and analysis.
Find out how Firma uses a lifecycle approach and why it is key to delivering a compelling, easily understood data story to the FDA for rapid approval and accurate labeling.