Many clinical research sites, regardless of their size, location, or number of years in the industry, tell us the same thing – they don’t have the staff, time, or other resources to negotiate their budgets and contracts, manage their accounts receivable, or stay on top of their financials.That’s where we step in with our more than 23 years of experience and unique perspective from the sponsor, CRO, and site aspects of clinical research.At The Pathways Group, our clients tell us where they want to go then we show them the way. We are always listening to see how we can assist and be ready to help them however we can.

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 16 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 and no withholding. He's a member of WCG Avoca’s Quality Consortium, Florence Healthcare’s Site Enablement League, and multiple SCRS committees.

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
-Review and negotiate your contracts and budgets
-Oversee your accounts receivables (AR)
-Audit your financials to see if you have left any money on the tableWe handle everything related to your CDAs and feasibilities then follow up with sponsors/CRO until site selection.With your input at every step of the way, we negotiate your contracts and budgets and manage the process until all of your documents are fully executedRevenue is the lifeblood of any clinical research site. To keep your cash flow healthy, we handle your accounts receivable by submitting invoices to sponsors/CROs, monitoring the status of payments, and following up on overdue payments.We love to conduct financial audits to help sites find money that sponsors and CROs owe them and help them recover those funds. We reconcile what your site has done versus what your site has been paid. We then contact sponsors/CROs to alert them that there are incomplete or missing payments and follow up until all payments are up-to-date.If your site wants to evaluate your financial processes, we start by helping you calculate the amounts to use on all of your budgets then guide you in the development of a fee schedule/charge master that incorporates these amounts. Then we’ll draft tools that will track and maintain this information and will help you update your numbers as factors at your site change and evolve. 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 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 logs

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.