Are You LMK Ready?

LMK Ready is LMK’s unique service offering specialized designed for small and medium sized life sciences companies. LMK Ready is a way to leverage an entire TMF Operations organization – TMF Consultants, Project Managers and Document Specialists for your company without having to incur the costs of a full-time headcount. More important than the cost considerations, LMK Ready provides broad-based and on-demand perspective around best practices in eTMF optimization, inspection readiness and overall TMF quality.

Oftentimes it is truly hard to see the forest for the trees and getting caught up in the operational realities of TMF management and can distract from major objectives and reduce focus on clinical trial execution. LMK Ready provides focused resources to drive go-to-market activities and has the added benefit of applying best practices and techniques seen across other companies.

Who Would Benefit from LMK Ready?

  • Companies that have an existing clinical operations team that needs guidance, perspective, and thought leadership.
  • Companies who are planning on making regulatory submissions in the near future or would like to start planning for one.
  • Companies looking to increase capacity whilst maintaining oversight of their clinical development programs.

The features of your modern eTMF system can’t replace the contributions of seasoned TMF experts. LMK Ready is here to provide this essential human element. Our TMF experts can help your team adapt to the unique and changing needs of each study, putting your organization’s larger TMF goals within reach:

Regulatory Requirements

Regulatory requirements can place a huge burden on your team, especially if your organization is new to eTMF creation or if a trial has many centers spread across multiple regions or countries. Tracking the regulatory requirements across each region can quickly cause an eTMF team to become out of sync – and the TMF to spin out of control. With LMK’s TMF experts, you can be confident that your TMF is built on a foundation of efficiently met regulatory requirements and clearly delineated regulatory expectations.

ICH GCP

The list of essential documents required by name in ICH GCP is only a small portion of what is required for an inspection ready TMF—so how can your team know what is expected? Our experts haven’t just read guidelines, they know how to implement them and have years of experience across thousands of TMFs. Let our experts teach your team to think like an auditor and provide valuable TMF-specific perspective on E6(R2).

Organization and Study Specific Information

Does your team struggle to account for the unique factors of each trial? Is your one-size-fits all TMF solution too inflexible and creating the very problems it was intended to solve? Let our TMF experts anticipate your trial’s challenges before the study is underway. With expertly designed TMF processes, your team won’t spend precious time and resources working against the eTMF.

Find Out More About Us

LMK Clinical Research Consulting, LLC (LMK), is a functional service provider of Trial Master File (TMF) consulting and services, named 4th fastest growing business in the Charlotte region by the Charlotte Business Journal. The life sciences industry knows LMK as a trusted leader for its dedication, quality solutions, and expert services in TMF.

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