LMK Clinical Research Consulting
A Step toward Proactive Clinical Trial Documentation

Trying to drive a car while looking at the rear-view mirror even on a straight road with no traffic can be dangerous. And it’s the same for businesses as well. Many traditional life sciences organizations often take a retrospective approach in their documentation process instead of planning with the end in mind. The setbacks of such an approach are now becoming all the more evident with the COVID-19 outbreak. While life sciences companies across the globe are on a relentless lookout to find the cure for the highly-infectious viral disease, they also need to adhere to the multitude of regulatory protocols to ensure a successful outcome. And time being the essence of the current situation, even a small error in the documentation process can delay a potential treatment. Moreover, with an increase in global cross-organizational collaborations in finding a cure of the novel coronavirus, maintaining and storing clinical trial documents in a more systematic manner for compliance and inspection readiness has become more critical than ever.

At this juncture, Sholeh Ehdaivand, the president and CEO of LMK Clinical Research Consulting, believes that in a heavily-regulated industry such as the clinical trial sector, a comprehensive and well-maintained Trial Master File (TMF) is the linchpin of success. These stored clinical research documents are critical to proving the validity of the clinical trial, indicate the quality of the data obtained, and ensure ICH Good Clinical Practice (GCP) compliance for all the personnel involved in the clinical trial. Driven by this belief, LMK partners with leading eTMF vendors in the market to build a robust technical knowledge-base of different TMF solutions and offer functional TMF consulting and services. “Our partnerships allow us to be eTMF-agnostic and focus on the people and the process,” highlights Sholeh.

Notably, LMK’s success is not only determined by its partnerships but also by its experienced leadership. Sholeh, with 15 years of experience in the clinical research industry, is well-versed in all areas of study management and every operational aspect of the clinical trials. Driven by this expertise, Sholeh and her team of experts take a systematic approach based on Six Sigma principles to understand each client’s unique TMF needs.

Our partnerships allow us to be eTMF-agnostic and focus on the people and the process

Upon the initial evaluation, the team develops a customized standard operating procedure (SOP) and selects an appropriate eTMF vendor. Further, the employees’ extensive knowledge in multiple disciplines of TMF ensures that the documentation process is handled ‘from soup to nuts.’ It begins with indexing the client’s documents with the TMF Reference Model. Alongside the documentation, the analysts review every minute detail of the records. To control the regulatory risk and keep the client inspection ready, LMK conducts a mock TMF inspection. This ensures that the documentation is accurately complete from the start through closeout in an ICH GCP compliant manner.

To this extent, LMK is also the co-lead for the Metrics Champion Consortium’s (MCC) TMF and inspection readiness metric stream. LMK has helped MCC create a metric stream for TMF. The MCC covers different metric sets, study startup, site budgets, remote-based monitoring, and more. Additionally, the company also partnered with Model Agreements and Guidelines International (MAGI) to create a reference model for site documentation.

Further substantiating the company’s prowess, Sholeh recalls an instance where a medium-sized pharmaceutical company needed help in setting up their eTMF. LMK took control of the situation and began with eTMF configuration, user acceptance testing (UAT), and system validation. At the same time, LMK developed a Standard Operating Procedure of ensuring that the clinical research documentation is contemporaneous with the ICH CGP (R2) regulations, clinical trial milestones and events. Moreover, LMK trained the client’s employees, CROs, and even the external stakeholders to use the eTMF system. To culminate the project successfully, LMK conducted a mock audit for the client ensuring all the processes and documentation were in place for the inspection. And the outcome of all the hard work was exceptional. The client went through the inspection without a single error in the documentation process, thereby obtaining approval from the regulatory authorities.

Such success stories are the reason LMK has established itself as a go-to name in the clinical trial landscape. Even in the challenging times of COVID-19, the company has witnessed a positive trajectory and has been able to retain all its employees and clients. Finally, as the era of personalized medicine is on the horizon, Sholeh believes that LMK is perfectly positioned to offer its expertise in the development of such tailored medicine. “We are performing exceptionally well, and the future looks bright,” concludes the president/ CEO.