Case Studies

A biotech company embarked on a pivotal journey within the realm of TMF. Their focus? A comprehensive respiratory program designed to address pressing healthcare needs. Entrusting crucial monitoring, data management, and regulatory functions to a clinical research organization (CRO) was a strategic decision. However, a formidable challenge soon emerged—the absence of a robust process for…

  Situation: In a high-stakes environment, a late-stage biopharmaceutical company engaged in an accelerated Phase 3 clinical trial encountered serious document management hurdles. Despite partnering with an eTMF solution provider, the company faced technical constraints and a significant lack of internal training and awareness regarding TMF management. This shortfall led to a precarious position regarding…

A small biotech company made the strategic decision to outsource the data management, monitoring, and regulatory functions to a trusted clinical research organization (CRO). However, amidst the transition, they inadvertently overlooked the critical need for a robust process to oversee the Trial Master File (TMF) throughout the study. Recognizing the potential risks and challenges associated…

How LMK’s TMF Consultants inspired a TMF leader to look beyond the wolf at the door and achieve TMF success with meaningful TMF metrics. TMF leaders face a growing challenge—a crisis of inspection readiness. Despite rapid advancements in eClinical and eTMF technology, GCP inspection findings continue to rise, a product of increasing clinical trial complexity…

How LMK’s TMF University inspired one new hire to overcome her trial by fire and become part of a new generation of TMF professionals. The life sciences industry faces a serious problem—a widespread trial master file (TMF) skills gap. There are simply not enough skilled TMF professionals to support the explosive growth and complexity of…

How LMK’s TMF experts empowered a growing sponsor to take back the reins of their TMF The Trial Master File (TMF) is the main deliverable of a clinical trial. If a clinical trial’s TMF fails, regulators will act swiftly to protect the safety of patients, and precious clinical data will be thrown into doubt. Despite…

Situation: Medline, a large manufacturer and distributor of medical supplies, migrated from a paper TMF to an eTMF system, Veeva, in order to have better control and visibility of the condition of their TMF at all times. While the goal was clear, the combination of limited TMF resources to implement the system and the team’s…

Situation: A late stage biopharmaceutical company working on a fast-tracked Phase 3 study was providing their own document management and recently partnered with an eTMF solution provider to manage their eTMF. Due to eTMF platform constraints and lack of TMF training/awareness, the company found themselves at risk of FDA non-compliance. With over 4000 backlogged documents…

Situation: A large international pharmaceutical company implemented a new centralized TMF program. As a result of the new program, the company lacked the trained resources needed to effectively manage the TMF program. LMK provided training and professional mentorship for the newly formed TMF Lead, TMF Project Manager and TMF Document Associates roles. LMK Solutions: For…

Situation: A small biotech company outsourced the data management, monitoring, and regulatory functions of their oncology program to a clinical research organization (CRO). Unfortunately, the biotech company did not have a process in place to perform oversight of the Trial Master File (TMF) throughout the duration of the study. The sponsor contracted LMK to provide Oversight Quality Control…