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.
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.
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.
