- What do Sponsors Need from Trial Sites?
- Market Your Site to Sponsors
- How to Get More Out of Sponsor Negotiations
- Tips for Negotiating with Sponsors
- How to Leverage Data to Maximize Sponsor Support
- Uncover Sponsor Funding Opportunities
- Position Your Site as a Regulatory Partner
- Selecting the Right CTMS and eClinical Solutions to Maximize Sponsor Relations & Opportunities
Maximizing Sponsor Relations, Negotiations & Opportunities
Learn how the right clinical research trial software can open doors and enhance your status with a site’s most critical audience – sponsors.
The importance of the sponsor/clinical trial site relationship cannot be understated. This essential partnership drives trial success throughout the globe and, when managed proactively, is critical to ensuring patient safety, healthcare innovation, and market growth. While the sponsor and research site responsibilities differ, they are closely aligned in terms of a trial’s ultimate goal.
Sponsor responsibilities include:
- Selecting the trial research partner
- Providing information necessary to conduct the trial
- Monitoring the clinical study
Site responsibilities include:
- Recruiting and managing trial patients
- Ensuring compliance throughout all facets of the trial
- Maintaining comprehensive trial data and providing reports
- Providing best-in-class CTMS and eClinical capabilities
Positive and collaborative relationships with sponsors are integral to site success. However, those relationships can only begin when a trial is awarded and sponsor/site partnership has begun. Thus, maximizing opportunities to become a site of choice and get study awards should be a top consideration for clinical research leadership focused on revenue growth. Ensuring staff has an understanding of site sponsors’ expectations is one element to sponsor-site success; another is site deployment of best-in-class clinical trial management software (CTMS) including eClinical solutions that enhance the digital capabilities needed by today’s sponsors.
What do Sponsors Need from Trial Sites?
Understanding what sponsors want is critical for clinical leaders. Increasingly, sponsors want to be ensured that performance is being monitored and reported upon accurately. Providing sponsors with predictability and reliability can set an organization apart and make it a loyal partner of choice. Sponsors should be able to easily understand how sites can provide predictable, reliable clinical trial results. A site can differentiate themselves by demonstrating how a clinical research team approaches enrollment and how data is tracked, recorded, and organized. Leveraging a powerful and comprehensive CTMS suite can help you provide complete data sets of accurate, actionable information so sponsors can clearly see the added value working with you provides to their bottom line.
Market Your Site to Sponsors
Communicating with sponsors before site selection, during trial execution, and after trial close is a critical element to maximizing sponsor relations and opportunities. Unfortunately, clinical trial administrators don’t often take advantage of the myriad of opportunities to tell their story to sponsors. Buck this trend by taking advantage of every sponsor interaction your team has by asking them about their concerns, future plans, and industry POV. Capitalizing on connections with current and potential sponsors can yield powerful, useful insights. Ask what data they are most interested in, what information they didn’t see in their initial search, and other gaps in the data your company is presenting. Taking that proactive step serves a number of purposes. It will ensure your team is better equipped to deliver the data necessary for sponsors to make decisions on awards in the future. Also, doing so demonstrates your team is interested in their feedback, proactive in data gathering, and delivering thorough performance.
Your historical clinical trial data tells the story of your organization. When sharing, point out impressive achievements, highlight processes, notable feasibility metrics and other numbers that help shine a spotlight on your successes. Getting out in front of the story helps ensure sponsors are aware of your accomplishments, capabilities and improvements. Harnessing data to tell the tale in the best way possible increases your chances of landing the award.
There are a number of relatively simple ways to amplify a clinical research “pitch” to sponsors including:
- After initial contact with a sponsor, follow up with emails containing notable performance data
- Include figures in your newsletters and other marketing collateral; share the story of your site statistics on your website
- Highlight relevant data to sponsor representatives in follow-up conversations, PSVs, SIVs, investigator meetings and other interactions
- Share your data in conversations with booth visitors and other attendees at industry or virtual trade shows and webinars
- Post case studies, whitepapers, and other news on your website, using verbiage on which you know sponsors are searching so they can easily find your work
How to Get More Out of Sponsor Negotiations
Once you’ve established relationships with sponsors, negotiations become a critical factor in both maintaining those positive ties and maximizing site revenue. Obtaining more from a sponsor negotiation depends on many factors, though it is always helpful to anchor your position with something of particular value and easy to communicate. Based on both the current clinical research environment and anticipated future needs of sponsors, remote monitoring is a smart place to focus upon for your negotiations.
The complexity, number of studies, and use of electronic systems has grown over the years, and so have the challenges to clinical trial oversight. In response to this trend, the FDA issued specific guidance that “specifically encourages greater use of centralized monitoring methods where appropriate.”What in the 2013 guidance was called “centralized monitoring” is now referred to as “remote monitoring”. Fast forward to today and we see the demand for remote monitoring capabilities growing fast for very practical reasons. With the FDA acknowledging that over 90% of monitoring concerns are able to be captured through remote monitoring workflows, the subsequent reduction of on-site monitoring visits to a minimum has resulted in significant savings for sponsors. Remote monitoring not only dramatically decreases sponsor costs for monitoring, it also decreases the frequency of having to physically visit sites.
In an ideal negotiation, the right solution balances the needs of both the sponsor and the study sites.
Obtaining the right technology tools may make the workflow easier, but they can also significantly enhance the negotiating stance. Deploying technologies like eSource, eRegulatory and eConsent not only ease the capture and preparation of data, they also provide the necessary remote monitoring capabilities. The centralization of information, ease of remote access, quality checks, automated reminders, and reduced data preparation effort results in considerable time and cost savings for sites.
Tips for Negotiating with Sponsors
For successful negotiations, sites must consider the full spectrum of benefits they bring to a sponsor. This often means thinking of site tools that haven’t historically been included in negotiation discussions, including technology capabilities. While the details of site technology are not mentioned directly in a negotiation with a sponsor, there are direct benefits to sponsors which could be creatively included in fee schedules and justification letters. For example, many sites have successfully received reimbursement for their transition to remote risk-based monitoring. This is because the same software that provides the remote access for the monitor is also the software that helps increase the quality and speed of delivery of the study data while maintaining compliance; making this connection clear to a sponsor will go far in negotiations.
The ideal approach is to do your homework regarding your organization’s actual capabilities, calculate related fixed and variable expenses, and include them in your fee schedule up front with simple descriptions. In the context of a clinical study, fixed costs are typically associated with costs per unit or activity related to tasks. In contrast, variable costs relate to time and effort or business costs such as overhead. By including remote monitoring data preparation and access technologies into an initial fee schedule, sites don’t have to over-emphasize the technology since it is expressed in terms of services and fees within the correct context. In addition, by keeping the initial descriptions brief, you leave room for more details if there is any pushback.
For fixed costs, be sure to include a short description of each role related to the monitoring tasks, since each task can be unique depending on who is performing it. This changes the FTE calculation. Also be sure to break down the difference in cost from traditional, onsite monitoring and remote monitoring. Even with your personnel, technology and other fees included, the electronic preparation of data and remote monitoring will cost much less for the sponsor than having to perform onsite visits. Some monitoring related items that may contribute to fixe” fees include:
- Site engagement visits with monitor pre, intra and post award
- Review of regulatory documents related to clinical trial conduct
- Document management (scanning, copying, faxing, de-identifying)
- Duplicate document submissions for review
- Ongoing document reviews (continuing reviews, amendments, and annual reviews)
- Safety report reviews and associated documents (SAE/AE/DSMB reports)
- Remote Monitoring access fee (could be “fixed” if pre-calculated in tiers)
The same holds true for variable costs; be sure to compare the more efficient electronic data preparation and remote monitoring costs (time & technology) to the usually much higher cost of any non-electronic and manual approaches that would result from the sponsor not accepting the proposed fee schedule. Several monitoring items fall under a “variable fee”. Below are some items related to monitoring that you can list in your “variable fee” justification items:
- Time and effort for all research staff (training, education, webinars)
- Ongoing communication efforts
- Allocated meeting times dedicated to monitor during external reviews
It’s also smart to have a site cost justification letter ready to quickly respond if there is sponsor pushback. This letter should include more capability statements and technical details delivered in a strategic way that aligns your offering to what sponsors value. By adding more detail and explanations to each fixed and variable cost you’ve already outlined, you can provide details covering resources, overhead, supplies, and technology tools used in support of remote monitoring in your justification letter.
How to Leverage Data to Maximize Sponsor Support
Data is an invaluable tool in the clinical trial toolbox—especially when it comes to managing sponsors. Accurate and current data demonstrates to potential and current sponsors that your organization is capable of effectively organizing, running and analyzing a successful trial—and delivering the results they need. Only half of US clinical trial outfits actually use a CTMS and it’s likely that less than 5% of sites track and maintain timing and performance metrics. It’s clear that sites that are able to provide visualized data on both current and past trials are at a distinct advantage. A lack of statistics equals uncertainty, and sponsors likely will choose sites that back promises of future performance with evidence that they’ve performed in the past.
Metrics that show your current site performance help your sponsor determine capabilities and a track record of success. You can harness this data through CTMS to create a baseline for standard performance, demonstrate improvement over time, and create benchmarks by which to gauge future performance. These metrics include, but are not limited to:
- Trials completed
- Patients available, screened, enrolled, completed, failed screening and dropped out
- Screening, enrollment and retention rates
- Percentage of contracts met
- Current studies in indication
- Past performance by sponsor/CRO
- Patients screened, enrolled, completed, screen-failed, early term (number or %)
A site that presents data indicating greater efficiency and less downtime offers an additional advantage to sponsors. Here are some timing-related figures that can be garnered through CTMS for which sponsors look:
- Cycle times: CDAs, feasibility, contracts, budgets, etc.
- Feasibility turnaround time
- Regulatory packet turnaround time
- Time from initial budget to contract execution
- Days spent at different stages of the process
- Time from site activation to commencement of screening
- Site activation to screening
Uncover Sponsor Funding Opportunities
Given increased speed-to-market demands and consumers’ increased focus on the clinical trial industry, site management should look beyond how CTMS and eClinical tools benefit your site, taking into consideration how sponsors benefit from its implementation and what enhancements sponsors might support with funds. For instance, with direct sponsor benefits of easier CRA prep and visits, sponsor support should be considered as a way for your organization to fund an eReg system. A significant amount of sponsor time during a trial is spent on site inspections to ensure all elements of patient safety, clinical data accuracy, and investigational protocol adherence. Digital records will make preparing for inspections less time-consuming and potentially reduce the amount of time inspectors are on site. This has real financial benefits for sponsors and one that you can clearly convey ROI. Work with your team to calculate end-benefits and incorporate eReg’s effect on CRA visit preparation as an element of study applications.
Position Your Site as a Regulatory Partner
Successfully managing Clinical Research Associate (CRA) site visits is a critical part of any clinical research organization. CRA monitoring, while a mandatory and non-negotiable part of managing and monitoring a clinical trial, has a very real impact on the daily work of your site. CRAs have the responsibility to ensure all elements of patient safety, clinical data accuracy, and investigational protocol adherence. With that in mind, what can your site team do to evolve your approach to CRA visits to one of partnership?
Perhaps the best tool to minimize CRA site visit impact is a transition to digitized regulatory management through deployment of an eReg system. Make CRA visit preparation a consideration when evaluating the deliverables and reporting needs of the transition to digital regulatory management. How might the very specific CRA requirements affect the process? Engaging your eReg partner in these discussions will be critical so they can help ensure you’re building a system that addresses the needs of both internal and external stakeholders
CRAs and site monitors are increasingly comfortable with digital regulatory practices so having the best system to track data will help make their job easier, often meaning an easier site visit for your organization and team. Early communication with monitoring organizations to alert them to your CTMS and eReg system configurations will allow their CRA staff to better prepare for visits to your site. Likewise, understanding specifically what they expect on-site allows your team to proactively prepare versus spending more time on last minute requests for data. And even when those ad hoc requests do arise, a digital system in place will enable finding and distributing the data in less time.
Selecting the Right CTMS and eClinical Solutions to Maximize Sponsor Relations & Opportunities
Finding the right CTMS and eClinical solution can be a rigorous process in and of itself. But a well-integrated system can make all the difference in sponsor relations and award opportunities for sites. Clinical research leaders need to carefully evaluate their business and anticipate what practices will positively impact their sponsor relations and opportunities now, and down the road. Effective digital management is critical for today’s sites that want to both improve outcomes and realize increased revenue.
Highlighting your sites CTMS, eReg, eSource, and eConsent capabilities can improve your business metrics exponentially. If you need help advancing your site’s preparedness, request a demo of our CTMS and eClinical solutions.