Halloran Partners with LMK Clinical Research Consulting to Enhance Clinical Trial Master File Management and Process Planning
Collaboration Provides Pharmaceutical, Biotechnology, and Clinical Trial Sites with Improved Clinical Operations and Development Capabilities
BOSTON – Halloran Consulting Group, Inc. (Halloran), a national consultancy that works with global life science companies to optimize development and performance, today announced a collaboration with LMK Clinical Research Consulting (LMK), an industry document management services provider, to enhance and streamline Trial Master File (TMF) management and processes for pharmaceutical, biotechnology, and clinical trial sites across the U.S.
Trial Master File (TMF) documents are critical in supporting compliance with clinical trial regulations and Good Clinical Practices (GCPs). They require disciplined document management, organization, and indexing and often are a major cause of negative findings in a regulatory inspection if not well managed.
One of Halloran’s services is transitioning life science companies operating models from a paper TMF to a fully electronic TMF (eTMF). LMK provides expertise to ensure the plans and processes are in place to maintain compliance according to exacting standards. The partnership augments Halloran’s eTMF management platform by adding LMK’s capabilities and experience in document management and process support.
“LMK’s expertise compliments Halloran’s services and technical expertise on eTMF solutions and implementation,” said Laurie Halloran, founder, president, and CEO of Halloran Consulting. “Our partnership augments the goal of streamlining eTMF processes and management, which in turn helps these companies improve clinical trial operations and compliance.”
“At LMK, we believe that the Trial Master File is the foundation of every clinical trial. Our partnership with Halloran allows LMK to support their clients in building a stronger, stable foundation by providing well trained, experienced resources and sustainable processes,” said Sholeh Ehdaivand, president and CEO of LMK Clinical Research Consulting. “Halloran’s service offerings and our processes and people are a complementary fit and will benefit small, mid-size, and large companies alike.”
“As a trusted advisor in technology consulting, Halloran is constantly monitoring the market of solutions and service providers, assembling a network of partnerships that can execute on the technology strategies we develop in collaboration with our customers,” said Mark Vermette, Halloran’s leading Principal Consultant in technology adoption. “Our expertise allows us to develop personalized technology roadmaps for our customers, in support of business goals, service partner strategy and organizational maturity. Halloran seeks out the right partnerships to succeed in executing those technology roadmaps.”
About Halloran Consulting Group
Halloran is a management consulting firm that partners with life science companies to optimize their development. Halloran works with industry organizations of all types, including biotech, pharma, medical device, and service providers, to identify gaps and implement solutions to achieve excellence in regulatory, quality, and clinical development. Halloran is certified by the Women’s Business Enterprise National Council as a woman-owned business. For more information, please visit www.hallorancg.com.
About LMK Clinical Research Consulting
LMK Clinical Research Consulting, LLC (LMK), is a Functional Service Provider of Trial Master File (TMF) consulting and TMF services. LMK is known in the life sciences industry as a trusted leader for our dedication, quality solutions and expert services in TMF. LMK is certified by the Women’s Business Enterprise National Council (WBENC) as a certified woman owned business. For more information about LMK, please visit www.lmkclinicalresearch.com.