TMF Rescue for Pivotal Phase III Study

SITUATION

Based on our reputation for quality and attention to detail, a Biotech organization approached CRMG to provide rescue trial master file (TMF) support for a large, global Phase III study. Upon an audit of the TMF at the sponsor’s then-CRO, multiple QA issues were identified including, but not limited to, a lack of compliant organizational structure for the TMF and missing documentation which provided them significant concern. Due to the pivotal nature of the trial, the sponsor expected stringent regulatory scrutiny of this information. Therefore, they contracted with CRMG to ensure the current trial information was in impeccable order, and would continue to be as the study moved forward over the course of the remaining half-year.

SOLUTION

1. Experience & responsiveness when it counts: Having an in-house group that has years of experience in performing TMF support, CRMG quickly employed a dedicated document manager to sort through more than 30 boxes of files received from the CRO, all of which were in no discernable order. Leveraging internal procedures, tools and checklists, CRMG systematically reviewed the TMF for completeness, assigning urgent action items for follow up with CRAs and investigator sites for a variety of missing documentation that was identified. CRMG reorganized the TMF to align to industry standards, providing a logical and functional organizational system that would ease future identification and review of clinical information for regulatory submissions. 
2. Persistence & quality when it matters: Within a few weeks, CRMG had reviewed and inventoried the entire TMF. Our document manager then designed and implemented a custom transmittal form for consistent receipt of materials. The tools that CRMG provided allowed our document manager to develop a strong relationship with the third party CRO’s clinical monitors, which reinforced compliance in the new process for maintaining the TMF. Further, our document manager continues to proactively interact with both monitors and investigator sites to ensure any loose ends in documentation are followed up on and closed quickly and efficiently.

RESULTS

CRMG was able to resource the project, perform a comprehensive review, inventory and reorganize the TMF within 4 weeks. Further, we installed systems and procedures in collaboration with the third party CRO monitors, sponsor and investigative sites to track essential documentation moving forward and ensure important information is maintained correctly for the foreseeable future. What started out as a 6 month project has turned into a continuing long-term arrangement and partnership currently in its fourth year of support.