lET US HELP YOU SHORTEN Study Start-Up TIMELINES AND GIVe YOU TIME BACK IN YOUR DAY.

With Initiate, our research administration experts collaborate with your team to help you grow your research program in a way that supports your vision.

Based on the needs of your institution, you will partner with teams specializing in coverage analysis, budget development and negotiation, contract redline and negotiation, and CTMS study builds. We understand the importance of target turnaround times, and we create a process that supports your turnaround goals. Initiate can help your organization shorten study start-up timelines, develop a legal playbook to keep you protected and mitigate financial and process risk, while increasing productivity. Whether you choose multiple Initiate services or just one, our priority is helping you accelerate study start-up while maintaining billing compliance.


Why partner for study start-up services?

Benefits

Improve Productivity.

Allow your research team more time to focus on clinical activities.

Mitigate Risks.

Limit your exposure to legal pitfalls and personnel turnover.

Maximize Budgets.

Secure additional funds to cover your costs.

Overcome Backlogs.

Get those amendments off of your plate and alleviate bill holds.

Improve CTMS ROI.

Get over the hurdles of timely calendar builds and milestone tracking.

Shorten Timelines.

Get transparency into turnaround bottlenecks and opportunities for process improvement.


Study Start-Up Services

coverage analysis

Regardless of where you are in your research billing compliance process, we can help you navigate Medicare billing rules by documenting how they apply to the delivery of your study protocol. This coverage analysis clearly lays out what your coordinators and billing staff need to know for each trial. It’s our job to determine which procedures and tests should be billed as routine or conventional care and which should be billed to the study sponsor. This helps your revenue cycle department avoid double billing procedures or miss billable revenue. Many of our clients came to us because they couldn’t find or keep the right expertise to conduct this analysis. Our team goes through PFS University, to ensure the highest quality and a consistent product.

 
We couldn’t keep up with the volume of study requests coming from our departments. A backlog began to form and continued for well over a year before we met PFS Clinical at a conference. I’m so glad we did. PFS Clinical helped us process the backlog requests, helped train staff on how to interpret a coverage analysis, and helped us initiate studies that were months overdue. The PIs wanted to know what had changed, and I was happy to point to our decision to partner with PFS Clinical.
— Executive Director, Sponsored Programs (Southeast)
 

Budget development & negotiation

Our dedicated staff will work to define a budget process for your team. Do you have a research chargemaster? Great. We work with clients that developed their own tools and we’re flexible in order to work within that process. You don’t have a research chargemaster? No problem. We can create tools that will help you improve financial outcomes, and we’ll focus on improving your bottom line. We know our way around sponsors and CROs. We’ll help you develop appropriate justification for your fees and create standards for turnaround timelines and overall study document execution. We set aggressive goals to shorten study start-up and address negotiation pitfalls. The biggest impact to study start-up timelines is frequent and consistent follow-up with sponsors and CROs. With PFS Clinical, you’ll have a dedicated partner that works to execute a budget that fits your needs.

 
PFS Clinical’s expertise in clinical research budgets has improved our entire financial outlook. At their direction, we’ve changed our overhead calculation, developed proper justification for fees, and analyzed costs related to staff time. We’ve turned our research program into a profitable endeavor. One unexpected benefit in partnering with PFS Clinical is that most of their fees are covered in the study budget. We’re proud to partner with PFS Clinical.
— Research Manager (Southwest)
 

contract redline & negotiation

Chances are your legal department is inundated with agreements that have nothing to do with clinical research. They may be focusing on vendor or facility agreements, that while important, do not help get treatments to patients quickly. PFS Clinical’s team of contract analysts have reviewed thousands of agreements for our clients. CDAs, CTAs, Data Use Agreements, Principal Investigator Compensation Agreements, Study Vendor Agreements are all within our capabilities. We pride ourselves on prompt service and consistent implementation of our clients’ risk parameters. You know how we mentioned that we know our way around sponsors and CROs? Leveraging our experience could be more important when negotiating agreements. We’ll help develop a legal playbook with your institution’s approved language and justification. Our standards decrease study start-up timelines and improve relationships with sponsors/CROs.

 
We were skeptical that PFS Clinical could field the volume of contracts we process each month, so we started with a pilot program. During the pilot, we quickly realized PFS Clinical was the right choice. They delivered on quality, turnaround, and customer service. After the pilot, we decided to outsource all research agreements to their contracts team. I’m speaking for my entire group when I say thank you.
— General Counsel (West Coast)
 

ctms study buildS

Any of our study start-up services can be delivered in custom templates or within a CTMS. We want to work with you to develop the most efficient and operationally useful processes. We want to be your partner in improving the ROI of systems, and as such, we can work in any CTMS or a process we develop together.

 
We were under pressure during CTMS implementation. Our IT team largely focuses on EPIC support, and they couldn’t allocate any FTEs to our research department. We partnered with PFS Clinical to help see us through workflow development and study builds. We couldn’t have done it without their leadership and execution.
— Director of Research (West Coast)
 

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