I cannot say enough great things about the incredible service, support, and knowledge-base that Infinite Clinical provided to me and my department on a company-critical clinical study which had been mismanaged by a prior big-box CRO. Deb and her team of clinical operations and data management professionals partnered with my internal team to transition a floundering clinical study and a misapplied database into a well-oiled, compliant, and supported study. This study transitioned to a new database, new stats management team, and added clinical operations support in record time with the highest degree of professionalism and attention to detail. The sites loved Deb and her team and saw them as a seamless extension of my internal team. Deb herself partnered with clinical research management to provide a great deal of guidance and expertise on the sourcing of a new corporate clinical database. Her knowledge base of system requirements, US and OUS legal/regulatory compliance needs, and data management requirements and tools placed her in a top tier role as a data and clin ops consultant. Many thanks to Deb and her team for a great project execution!
Elizabeth Smith
Sr. Director, Clinical Affairs
Multi-national Medical Device Company
I hired Deb Lenhart as Head of Clinical Data Management during my time at Trialspark where I served as Head of CRO services.
Having worked in the clinical trials industry for over 23 years – I have rarely encountered an individual with Deb’s knowledge of both the technology and processes that drive successful data capture and analysis in the industry. Her ability to communicate those abilities to both internal colleagues and clients was peerless.
She was a pleasure to work with, insightful and generous with her time. She worked tirelessly to support the development of TrialSparks unique data management platform, coupled with her efforts to support the development of a quality management system to support it.
I have no hesitation in recommending Deb in any senior data management or consulting role.
Mike Ryan
Executive Vice President
Eversana
As a Clinical Consultant for our company, Deb meticulously oversaw data management for several large decentralized, and site-based clinical research studies. Our Research team relied heavily on Deb’s expertise in data management and wouldn’t have been successful without her.
Deb was always available to answer questions or lead a last-minute meetings with staff, making her an invaluable asset to our organization. Deb’s data solutions have streamlined our processes and significantly impacted efficiency. Infinite Clinical Solutions has set the bar high for Clinical Data Management! I have no hesitation in recommending her services and hope to work with her again in the future.
Meagan Bowen, M.S. Ed., RPSGT
Research Project Manager
Deb Lenhart is one of the most talented data managers I have worked with in our life sciences industry. Given her clinical background as a nurse, Deb brings a multi-dimensional view to data management and data science. Deb's wealth of insightful and tangible pearls on every project makes her unique and an indispensable valuable member to any clinical development organization.
Gavin Choy
President
CrystalGenomics, Inc.
For two years, I have had the pleasure of working with Deb Lenhart and her team at Infinite Clinical Solutions, LLC. Deb and her team provided our research company with several vital services including Clinical Data Management and Standard Operating Procedures (SOP) development.
Deb was such a valuable resource during the Electronic Data Capture (EDC), Randomization, and Trial Supply Management build. She went above and beyond in assisting with user acceptance testing and created an EDC that met our study needs. She provided our team with data guidelines and tips on how to best manage query resolution.
Infinite Clinical Solutions assisted our company with revising our Standard Operating Procedures. Deb assisted in narrowing down and identifying SOP topics relevant to our company. She also provided us with content SOP content and edits.
It has been a pleasure working with Deb and her company. Deb provided us with invaluable regulatory advice and guidance.
Alisha Henderson, MS, MEd
Manager of Regulatory Affairs and Quality Assurance
As Head of Data Management, Deb played a valuable role at the company through her wealth of knowledge surrounding data management and other industry practices. Deb was always a professional and hardworking colleague and a valued member of the team, and it was a pleasure supervising her.
CTO
Start-up Company
I have worked with Deb in different capacities over a span of 8 years, mostly as a data manager and building out databases for various studies I have been involved with. Whenever I have a question or issue, she is the first to address and resolve. She is tireless, committed and dedicated to the project and extremely dependable.
Deb Neff and Infinite Clinical Solutions are top of my mind always, if and when I need Clinical Data Management services.
Scott Hubbard
Sr. Director Global Business Strategy
BioSerenity
I have had the pleasure of working with Infinite Clinical Solutions and Deb for the last few years. The amount of knowledge and expertise that Deb and her team bring to the table is priceless. Infinite has been responsive, engaged and remains a key ingredient to our success in closing projects and meeting sponsor deadlines.
Nisar Ashraf BSRC, CRT-SDS,
RPSGT, RST
Head of Research Business Development and Operations
Deb and I have been working together on multiple studies in immuno-oncology. She is very talented and has a unique skillset, which makes her an asset to any team. Her strong safety and data management background brings value and efficiency to the process. It is a pleasure to work with her.
Sr. Clinical Trials Manager
Clinical Development and Clinical Operations
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