Achieve your clinical goals.
Built on decades of specialized expertise, we are dedicated to a collaborative approach that accelerates the development of safe and effective healthcare solutions. Learn how our customized operational approaches helped these clients achieve their clinical goals.
Learn how three clients relied on Firma Remote Visits to ensure safety monitoring, meet study endpoints, and complete studies before or within timelines.
Client: Mid-sized pharmaceutical company
Project Focus: Rapid support
Results: The client successfully enrolled their first patient into the study on time, and Firma provided appropriate required safety monitoring for this patient and the client’s trial.
Client: Mid-sized pharmaceutical company
Project Focus: QC in training and trial oversight
Results: Our team maintained a data clarification form (DCF) rate of less than 3% throughout the duration of the trial, resulting in high-quality data and highly-satisfied sites and client.
Project Focus: Rescue trial containing Remote Visit Services
Results: The client improved management of patient enrollment and safety parameters resulting in better site and patient engagement, and higher trial operational efficiency.
Learn how three clients relied on Firma Data Services to deliver speedy database integration and summary analyses to meet regulatory requirements.
Project Focus: Full data management and biostatistics-service rescue
Result: The client’s ANDA was successfully submitted in accordance with the original timeline at the end of a 2.5 month contract with Firma, and was approved by the FDA.
Project Focus: NDA submission support
Result: Firma converted the 27 Phase 1 & 2 studies from non CDISC-compliant data sets within seven months. The NDA was submitted on time.
Project Focus: FDA-requested analyses
Result: The additional analyses were performed and submitted to the client in 30 days. As the result of this successful support, the NDA was approved by FDA and Firma received an “Outstanding Achievement Award” from the client.
Learn how three clients relied on Firma Medical Writing to produce timely, quality medical writing deliverables that meet regulatory requirements.
Project Focus: Regulatory submissions
Results: The Firma team completed writing and compilation ahead of schedule for the first submission, and on schedule for the second submission. Both submissions were accepted for review, without issues, by the FDA, enabling the sponsor to reach agency approval ahead of several competitors and increase their revenue.
Project Focus: Narrative rescue
Results: All narratives were successfully finalized and submitted by the original due date. The rescue collaboration allowed the client to maintain their regulatory requirements and project timelines.
Project Focus: Departmental optimization
Results: Firma established communication plans to ensure strict adherence and follow-up with meeting action items. Subsequently, communication improved without the burdens of additional meetings, emails, and calls, increasing team efficiency and departmental production.
Learn how three clients relied on Firma Regulatory Services to produce timely, quality, and successful regulatory submissions.
Client: Global, mid-sized pharmaceutical company
Project Focus: Regulatory submissions
Results: The client’s IND was filed ahead of schedule and accepted by the FDA.
Client: Mid-sized pharmaceutical company
Project Focus: Strategic development plan
Results: A strategic development plan created by Firma allowed the client to adjust their risk-based approach to successfully advance their product through development while lowering development costs.
Project Focus: Regulatory operations
Results: Implementation of a strong and comprehensive plan allowed the Firma team to complete the project one week ahead of schedule, allowing the client to focus their attention on other critical-path activities and achieve their submission on time.
Learn how three clients relied on Firma Clinical Pharmacology & Consulting to assess project data and deliver recommendations ahead of schedule.
Client: Large, global pharmaceutical company
Project Focus: Pharmacological consulting
Result: The project was completed early allowing submission ahead of schedule by the client, with the regulatory body agreeing with the Firma-developed analysis approach.
Client: Mid-sized, US-based company
Project Focus: Pharmacological consulting for pediatric trial
Result: Utilizing their experience and the available information, the Firma team provided an assessment that was labeled as “exceptional” by the client and resulted in further study evaluation and confident development progression.
Project Focus: Data analysis
Results: Firma successfully completed the assessment within only one month of initiation, despite the project requirements of complex extrapolation and analysis. Based on our findings, the client moved forward with additional Phase 1 and Phase 2 studies, enabling them to focus their development investments into the most appropriate candidates.
Learn how these clients relied on Firma Clinical Operations to provide quality trial oversight, produce accurate file reconciliation, and facilitate timely database lock.
Project Focus: Trial Master File (TMF) rescue
Result: The client was provided with a resulting streamlined, consistent file structure for support of their upcoming FDA submission. Firma’s efforts ensured the client met their communicated FDA deliverable timeline, and with high-quality submission materials.
Project Focus:Supplemental monitoring support
Results: All outstanding queries were resolved, complete 100% SDV on over 1,000 outstanding data points were completed, and the project was successfully driven to database lock within expected timeline.
Project Focus: TMF conversion
Results: The paper TMF was successfully transferred into electronic form and continued to manage the eTMF in the electronic system. The sponsor is now better positioned to maintain their research progression and ultimate submission to FDA.
