We strive to make sure that sites do not pay out of pocket for our services and that anything that we do for them is covered in their budgets. We use a flat fee, fee-for-service model. Since we do not take a percentage of a site's final budget, a greater portion of the revenue generated remains with the site.Many sites, regardless of their size, location, or number of years in the industry, tell us that they don’t have the staff, time, or other resources to effectively negotiate their budgets and contracts, oversee their accounts receivables, stay on top of their financials, or handle their regulatory processes.Using our 25+ years of experience and unique perspectives from the sponsor, CRO, and site aspects of clinical research, what we do here at The Pathways Group has proven to improve sites’ cash flow and revenue streams while helping them be more profitable and financially savvy.

About

Matt Lowery, ACRP-CP, CCRC

Matt is the CEO of The Pathways Group, LLC and our principal consultant. Originally from a small town in South Carolina (ask him from where – it’s a great story), he started in the medical field not long after graduating from the University of Tampa. While working in a public health, community-based setting, he had his first taste of clinical research where he learned to consent patients enrolling in drug trials. Since then, he’s held positions in corporate medical research offices, managed sites, and found his niche consulting.Matt has over 18 years of experience in clinical research at the site, sponsor, and CRO levels. On the site side, Matt has worked as a study coordinator, regulatory coordinator, site manager, director of clinical research, and assists other sites with general consulting, business development, and budget/contract negotiation. On the sponsor and CRO side, he’s gained knowledge and experience in monitoring, clinical operations, TMF management, finance and accounting, and has drafted and revised several protocols for Parkinson’s disease and provided insight for protocols for Alzheimer’s disease, autism, hallucinations, multiple system atrophy, and schizophrenia.Matt holds certifications through the Association for Clinical Research Professionals (ACRP) – the ACRP-CP since 2018 and the CCRC since 2013 – and is a member of ACRP, Society for Clinical Research Sites (SCRS), and the Society of Clinical Research Associates (SOCRA).He’s a familiar face at research conferences where he presents on multiple topics such as budgets, business development, site selection, study start-up, site adoption of new technology, and eISF/eTMF/eReg and site/sponsor/CRO relationships.Matt is involved with initiatives that will improve the industry, participates in multiple site advocacy groups, and fights for site-friendly policies at the national level such as site-friendly payment terms, including monthly payments, no withholding, and appropriate overhead rates.

For Sites

The Pathways Group’s passion is working with sites, whether they’re well-established with years of experience or a newcomer wanting to do things right from the beginning. We prioritize each site’s goals and challenges and utilize a collaborative approach to solve the unique and complex challenges because each site is different.To help you navigate the ever-changing landscape of clinical trial budgets, contracts, and finances, we:
-Manage your confidentiality agreements and feasibilities then follow up until site selection
-Review and negotiate your contracts and budgets and manage the process until you have fully executed documents
-Oversee your accounts receivables (AR) by submitting invoices, monitoring the status of payments, and following up on anything overdue
-Audit your financials to see if you have left any money on the table then help you recover those fundsIf you want to evaluate your financial processes, we help you calculate the amounts to use on all of your budgets then develop a fee schedule/charge master. Then we’ll draft tools that will track and maintain this information and will help you update your numbers as your site evolves. Finally, we’ll help you implement a plan so you can use your fee schedule/charge master on every study.We’ve also worked with many sites to guide them in drafting templates, policies, and justifications. Sites use these so that sponsors and CROs have the supporting documentation they need to approve a site’s budget. The topics of these policies and justifications vary from site to site but to name a few:
-Overhead rate
-Monthly payments
-No withholding
-Start-up fees
-Use of site-specific logsWhen implemented and managed properly, an electronic regulatory (eReg) system streamlines the handling of essential regulatory documents and is a huge step in a site becoming less dependent on paper. We assist sites with all things regulatory without the need for you to hire, train, or manage additional staff, including implementing an eReg system. We’ll oversee everything from start-up to monthly maintenance to amendments to continuing review to close out. And because an eReg system has e-signature functionality, we’ll also manage that process not only for regulatory document, but also for any non-reg documents like agreements, memos, notes to file, etc. If the costs of your eReg system and other things related to regulatory aren't being covered in your budgets, we can show you how to change that.

For Sponsors and CROs

We use our extensive list of sites to assist sponsors and CROs with site ID and site selection. We've also drafted CDAs, budgets, and CTAs for sponsors and CROs then managed the site-facing negotiations and processed study-related site payments.We've been involved with study design and helped develop, review, and proof protocols.Savvy sponsors and CROs have asked us to help mitigate barriers to recruitment and enrollment, which decrease amendments and other things that cause delays. We do this by providing the site and patient perspective on clinical trials via groups of patients, caregivers, and sites that provide feedback on study design.

Contact

We'd love to hear from you! Send us your name and email address along with a quick message telling us how we can help.