Pharma Start
Firma Clinical Research is a specialized contract research organization (CRO) dedicated to providing innovative, patient-centric, and flexible clinical trial services. Their expertise spans decentralized trials, biostatistics, data management, and global studies, with a focus on improving patient recruitment, retention, and diversity. They support sponsors and CROs with tailored solutions including home trial services, biostatistics, clinical data management, and support for multi-national studies, aiming to streamline clinical research processes and enhance trial outcomes.
Industries
Nr. of Employees
small (1-50)
Pharma Start
861 Parkview Boulevard, Lombard, IL 60148
Services
Operational delivery of protocol visits in patients' homes or other decentralized locations by trained clinical personnel, including sample collection, vitals, EKGs, medication administration, and patient education.
End-to-end biometric services including study design support, statistical analysis plans, sample size calculations, PK/PD modeling, DSMB support, statistical programming with QA/QC, and integrated safety/efficacy summaries for regulatory submission.
Platform-agnostic EDC database design, rapid build-and-release services, comprehensive data cleaning, query management, medical coding and generation of SDTM-compatible datasets for lock and submission.
Flexible resourcing model supplying trained data specialists, statisticians, and programmers as embedded or extension teams to sponsor/CRO operations.
Interventions for studies at risk of missing submission milestones including accelerated database builds, output programming, and generation of analysis/report shells to meet regulatory timelines.
Creation and delivery of protocol-specific training curricula for home-trial providers, qualification exams, maintenance of CVs/licenses/training records, and availability of trainers during visit execution.
Operational delivery of protocol visits in patients' homes or other decentralized locations by trained clinical personnel, including sample collection, vitals, EKGs, medication administration, and patient education.
End-to-end biometric services including study design support, statistical analysis plans, sample size calculations, PK/PD modeling, DSMB support, statistical programming with QA/QC, and integrated safety/efficacy summaries for regulatory submission.
Platform-agnostic EDC database design, rapid build-and-release services, comprehensive data cleaning, query management, medical coding and generation of SDTM-compatible datasets for lock and submission.
Flexible resourcing model supplying trained data specialists, statisticians, and programmers as embedded or extension teams to sponsor/CRO operations.
Interventions for studies at risk of missing submission milestones including accelerated database builds, output programming, and generation of analysis/report shells to meet regulatory timelines.
Creation and delivery of protocol-specific training curricula for home-trial providers, qualification exams, maintenance of CVs/licenses/training records, and availability of trainers during visit execution.
Expertise Areas
- Decentralized clinical trials (DCT) and home-based visits
- Clinical data management and EDC implementation
- Biostatistics and advanced clinical trial analysis
- Statistical programming and submission-ready outputs
Key Technologies
- Electronic Data Capture (EDC) systems
- eSource / direct data capture (DDC) and eCRF/eCOA platforms
- Telehealth / virtual visit platforms
- Statistical software (e.g., SAS and equivalents)
News & Updates
Nikki Skirvin discusses the complexities of running multi-national clinical trials and key considerations for success.
Melissa Nezos explains how Firma’s home trial services increase patient engagement and retention, especially during the pandemic.
Dr. D.J. Tang provides insights on advanced data analysis methods suitable for unconventional clinical trial designs.
Nikki Skirvin discusses challenges and solutions for managing global trials with home visit components.
Melissa Nezos highlights how Firma’s in-home services improve patient experience and trial outcomes.
Firma discusses the benefits of outsourcing biostatistics, including expertise, cost savings, scalability, and impartiality.
Nikki Skirvin discusses the complexities of running multi-national clinical trials and key considerations for success.
Melissa Nezos explains how Firma’s home trial services increase patient engagement and retention, especially during the pandemic.
Dr. D.J. Tang provides insights on advanced data analysis methods suitable for unconventional clinical trial designs.
Nikki Skirvin discusses challenges and solutions for managing global trials with home visit components.
Melissa Nezos highlights how Firma’s in-home services improve patient experience and trial outcomes.
Firma discusses the benefits of outsourcing biostatistics, including expertise, cost savings, scalability, and impartiality.