Clinical Operations
Smoother, faster trial start-up. Transparent negotiation and payment processes. Improved investigator relationships. Shorter cycle times. These are among the many benefits you can expect when you engage CFS to manage the site activation and financial aspects of your clinical trial. We offer in-depth knowledge and global expertise with regard to clinical trial budgets, contracts, and finances as well as streamlined and technologically advanced processes that lighten your load and allow you to focus your efforts on other vital trial activities.
Site Activation Services
Tight timelines and complicated documentation requirements threaten to delay the start of every clinical trial. Outsourcing your investigator site activation tasks to CFS enables you to maximize the number of sites that are “enrollment ready” once the enrollment phase begins. This accelerates your clinical trial enrollment, which in turn allows you to complete trials sooner and bring your product to market faster. The benefits of our Site Activation Services include:
- Transparency: The CFS project dashboard provides 24/7 access to the regulatory document collection activities for your trial. You no longer have to wait for a project status report to see where your sites are in the regulatory document collection process because you can log in to the project dashboard at any time for an up-to-the-minute status of this critical start-up activity.
- Efficiency: Regulatory and financial disclosure documents are pre-populated with investigator data from our enterprise-wide database, avoiding redundancy and dramatically decreasing the time it takes for investigative sites to complete this paperwork. This capability alleviates frustration at investigative sites and enhances site satisfaction with your organization.
- Compliance: Our automated processes and quality assurance checks ensure that essential regulatory documents are completed correctly and quickly. With respect to the regulatory requirements around financial disclosure, CFS has a proprietary Financial Disclosure Management system in place to ensure that financial disclosure questionnaires are in compliance with 21CFR Part 54.
Global Contract Management Services
Our team of skilled professionals, supported by robust tracking systems and workflow management processes, maximizes the number of sites that are ready to enroll by your scheduled “first patient” milestone. CFS streamlines the contract negotiation process for both sponsors and investigative sites and maintains a contract completion rate that betters industry standards because we offer a dedicated infrastructure and structured data environment. The benefits of our Global Contract Management Services include:
- Accelerated Cycle Times: Site profiling enables us to leverage contractual information based on previous studies and track relevant information for use in future contract negotiations.
- Enhanced Transparency: Our project dashboard offers a clear view of any and all contract changes as they happen, allowing you to manage your trials with confidence and at your convenience.
- Improved Budget Management and Compliance: We negotiate grant budgets with investigative sites on your behalf and help maintain fair market value (FMV) standards for grants.
- Risk Management and Standardization: Because we know what sites are requesting with each successive engagement across your portfolio, we eliminate negotiations made in a vacuum and help you implement consistency of terms and conditions across your sites.
- Global Legal Support: CFS offers centralized access to “local” legal support worldwide.
Global Payment Management Services
The primary focus of your Clinical Operations department is to make sure your trials are proceeding as planned—not to ensure that investigator payments are made accurately and on time. Engaging with CFS for Global Payment Management Services offers your team significant benefits:
- Improved Investigator Relationships: The ability to pay investigators on time and with transparency gives sponsors a real competitive advantage when recruiting investigative sites. With CFS, investigators are paid monthly for patient visits and pass-through activity based on an automated data extraction process, and our site portal gives investigators a clear view of exactly what they are being paid for.
- Faster Cycle Times: Because we extract payment information from EDC data, investigative sites are incentivized to input these data more quickly, ultimately providing trial results faster.
- Better Cash Flow Management: With CFS, you are no longer responsible for telling Accounts Payable what to pay, and you no longer need to field questions and complaints from investigators about late or unclear payments. We manage the process; we field the questions.
- Reporting Transparency: Our protocol-specific sponsor portal makes payment information easily accessible at all times and improves compliance with aggregate spend reporting.
