Services
Make Your Site Efficient and Profitable!
Our team has decades of experience in clinical research as site managers, coordinators, CRAs, and more. We can help you take full advantage of technology to help you run more efficiently!
Whether you need extra training for new coordinators, upkeep of your CRIO eSource after an amendment, or a part time assistant to manage financials or regulatory, our team has the experience to jump right in.
Invoicing and Accounts Receivable Management
Your sponsor certainly won’t tell you when you’ve missed billing that MRI, but we can set up systems to track every visit and invoiceable, and reconcile your incoming payments to ensure nothing gets missed.
eRegulatory
Have you thought about transitioning to eReg but don’t have the staff time to coordinate it? We can make it happen with support, training, and a plan. Our consultants can also fill in while a regulatory support position is vacant, or if you don’t quite need a full timer yet!
CRIO Specialists
Configuring new studies is no small feat. We’ll help you every step of the way, including with financial builds, auditing, training your staff, and even switching existing studies. We also offer continual support for ClinicalResearch.io (CRIO) sites for ongoing questions and advice.
Financial Services
How We Can Help
It’s no question that keeping current on your finances is an essential part of running a clinical research facility. But it’s also frequently pushed aside when things are busy. Don’t assume that the sponsor will pay you what you’re owed automatically! Hire us to create invoices or follow up on outstanding visits on your behalf so that you can focus on the important stuff: your patients.
If you’re not watching your bottom line and making sure you’re getting what you’re owed in your contract, you could be leaving huge amounts on the table. We’re happy to help with all aspects including:
- Negotiating budgets for new studies, including all applicable start-up, maintenance, and close-out fees
- Ensuring contracts are updated with each protocol amendment
- Reconciling incoming payments against outstanding visits
- Following up on overdue invoices and incorrect payments
- Properly invoicing for all fees present in the contract
Take the pain out of financial management by working with us. We’re not afraid of crunching numbers and we’d love to help you streamline and speed up your process in any we can.
eRegulatory
eRegulatory systems are designed to replace traditional paper-based regulatory binders in clinical trials. They are a centralized platform to organize, manage, and store all of your regulatory documentation in an electronic format. No need to print hundreds of pages a month just to stuff it in a binder – keep it easily accessible online!
An eReg system like Veeva SiteVault or ClinicalResearch.io eReg will ensure that your clinical research site meets legal and regulatory obligations so that you can focus on your studies. While these systems are intended to assist you, the learning curve can often feel daunting. If you’re interested in using an eReg for the first time, or even switching over to a new system, you may not know where to start. That’s where we come in.
We can help you set up an eReg from scratch —including transferring your active studies as well as setting up for new ones. Or, we can help you make a painless transition from one system to another. We also provide training and ongoing support as needed.
Our Services
As a specialized consulting agency for clinical research sites, we understand the challenges you face and offer tailored solutions to make your eRegulatory system work for you. Here’s how we can help:
1. Individualized eReg Transition Planning
When deciding to transition to a new system, we’ll talk with you and your team about the status of each study and what your current organizational system is like. It may make more sense to continue paper regulatory for studies close to close-out, or to transition only some types of documents.
2. Staff Training
Successful implementation depends on your team understanding how to use the system effectively. We provide in-depth, hands-on training sessions that empower your staff to manage regulatory documentation confidently and efficiently.
3. Compliance and Audit Readiness
Navigating regulatory requirements and staying monitoring-ready while transitioning systems can be complicated. We can also provide auditing services during transition, ensuring that any gaps present in the old system won’t transfer to the new one.
4. Document Migration and Workflow Optimization
Transitioning to an eRegulatory system doesn’t have to disrupt your operations. We assist in migrating your existing documents, setting up workflows, and optimizing system usage so your team can focus on conducting research instead of managing paperwork.
5. Ongoing Support and Maintenance
Our relationship doesn’t end after implementation. We provide continuous support to address any challenges, optimize performance, and train new staff as needed.
Clinical Research IO (CRIO)
Our Expertise
Clinical Research IO (CRIO) is a full-featured clinical trial management system designed to manage all your site’s operations, from data collection and regulatory compliance to financial tracking. Implementing this platform and learning all its ins and outs can seem overwhelming – but you can have a helpful, friendly CRIO expert available just an email away!
We help you take full advantage of CRIO’s capabilities by offering eSource and financial builds, staff training, protocol amendment updates, and seamless study transitions. Our ongoing CRIO support ensures your team can focus on conducting high-quality research without barriers to proficiency.
How We Help You Manage CRIO
Our team provides a range of services to ensure your research site can implement and use CRIO effectively. Here’s how we can help:
1. Finance-Savvy eSource Builds
Setting up accurate financial structures in CRIO is critical for managing study budgets and ensuring profitability. We help you:
- Build comprehensive budgets tailored to capture every visit and invoice.
- Set up invoicing workflows to track payments and prevent revenue loss.
- Automate financial reporting for greater transparency.
2. Auditing for Accuracy and Compliance
Errors in your CRIO setup or data can disrupt operations and lead to compliance issues. Our team provides thorough audits to:
- Identify and correct inaccuracies in financials, visit tracking, and data entries.
- Ensure compliance with protocols, sponsor requirements, and regulatory standards.
- Optimize workflows for increased efficiency and reduced errors.
3. Staff Training
For your team to fully utilize CRIO’s capabilities, proper training is essential. We offer:
- Customized training programs tailored to your site’s needs.
- Hands-on sessions to ensure staff feel confident and proficient using CRIO.
- Ongoing education for new team members and updated system features.
4. Switching Existing Studies
Transitioning active studies to CRIO can feel daunting, but we make the process seamless. We’ll set up an individualized plan for your site!
- Migrate source data and financials from your existing systems for active studies.
- Build new studies or customize existing builds to ensure all budget items are captured accurately.
- Set up workflows so your studies continue running smoothly post-transition.
5. Ongoing CRIO Support
As a perk of partnering with us, we offer continual CRIO support to keep your research site running at peak performance. This includes:
- Troubleshooting technical issues and resolving problems quickly.
- Helping with new study setups, updating eSource for protocol amendments, and incorporate staff feedback.
- Providing overall guidance on how to use CRIO’s many capabilities such as advertising expenditure tracking and digital delegation logs.