Global Contract Management Services
Efficient execution of clinical trial agreements with investigative sites is integral to the activation of any study, with pivotal start-up activities contingent on this process. CFS offers a wide array of contract management services that accelerate contract cycle times, minimize financial risk and improve your relationships with investigative sites. Our enterprise solution is adaptable and highly scalable to meet the growing demands of pharmaceutical and medical device research and development.
We have taken the best principles of contract lifecycle management and applied the intelligence required to manage the complexities of clinical trial agreements and associated site activation documents. Our service enables the complete lifecycle management of your clinical trial agreements, from budget and contract creation, negotiation and electronic signature to storage, compliance and analytics. Through our advanced systems and highly experienced people, CFS Global Contract Management Services successfully deliver the delicate balance of accelerated cycle times with risk management, cost control and the all-important investigator relationship.
Key Features
- A highly skilled team of contract professionals with relevant industry experience
- Dashboards that facilitate transparent collaboration
- Proprietary Negotiation Tracking System (NTS) that provides automated workflow and complete contract lifecycle management with e-signature capabilities
- Site profiles that streamline future negotiations and eliminate redundant work
- Robust, near-time status reports and cycle-time metrics
- Electronic signature of clinical trial agreements
- Electronic storage of all contracts, budgets and related documents
- Centralized access to global legal support in more than 60 countries
- Seamless integration with CFS Global Payment Management Services
Outstanding Benefits
- Standardized approach for compliance and risk management
- Accelerate cycle times—enabling faster study initiation
- Decreased site and sponsor frustration as a result of streamlined processes
- Reduced overall clinical trial costs through shorter cycle times, more effective negotiations and the ability to redirect resources to other value-added activities
Components of the Contract Management Service
Budget Negotiation
Budget negotiation has two key components—development of the investigator budget and negotiation of the budget amounts and payment terms.
- Investigator Budget Development: We believe that the success of a budget negotiation actually starts with the development of a fair investigator grant budget and payment schedule. When developing a budget, most sponsor companies either rely on their own limited investigator grant data or subscribe to a cost benchmark database. The sponsor-data approach may provide a realistic view of what the sponsor has historically paid, but it does not offer the industry-wide cost perspective that is paramount to achieving FMV. And with a benchmark database, you need staff with the right expertise to read and understand the protocol and translate that protocol to a budget with a clear, executable payment schedule—in a standardized fashion that is repeatable to support compliance from a FMV perspective.
Our Global Contract Management Services staff will work with your clinical team to develop a realistic investigator grant budget that is supported by current industry data. If you already have a budget developed, CFS experts can provide a consultative review and analysis to ensure that it is in line with the requirements of the protocol as well as the latest industry trends.
- Investigator Budget Negotiation: We recognize that some organizations have a decentralized investigator contracting process in which the budget and contract negotiation responsibilities are divided among two or more departments. In engagements for which only the investigator budget responsibilities are being outsourced to CFS, we will work closely with your contract group to help ensure a seamless and integrated negotiation process with the investigator sites. To help you derive the most value from this service, we will develop budget parameters that establish the negotiation thresholds for each key budget item. The CFS Contract Team works diligently to negotiate budgets within those thresholds and will partner with you when requests are made that fall well outside the pre-established parameters. Your clinical teams need to remain focused on the other crucial study initiation activities, so CFS uses a wide array of data and negotiation techniques to minimize the number of budget requests that require your input.
Contract Administration
Offering a comprehensive contract administration solution, CFS delivers all of the efficiencies and benefits of contract management processes while leaving you in complete control of the negotiation. All of the administrative aspects are handled by CFS, including obtaining site contact and payee information, preparing the clinical trial agreements, sending the agreements to the investigator sites, tracking and following up with sites to ensure a timely turnaround of the agreement, and facilitating the execution of the final, legally approved agreement. By shifting these tasks to CFS, you gain much needed capacity that can be used to negotiate the budget and contractual terms with the site.
This service is ideal for organizations in which the legal department serves as the lead negotiator of the clinical trial agreement and project team members are responsible for all of the administrative tasks related to the agreement. In addition to the resource savings, our clients can leverage our proprietary Negotiation Tracking System to facilitate their negotiation activities. Working in close partnership with your organization to maintain the system during your site negotiations, CFS allows you to maintain live, near-time insight into your negotiation process. Organizations that need to retain negotiation responsibilities will benefit tremendously from our customized contract administration service due to the value of combining our experienced staff with our innovative processes.
Contract Negotiation
At the heart of the CFS Contract Negotiation service is our experienced Contract Team supported by our Negotiation Tracking System, a proprietary approval flow system that manages the lifecycle of a contract from inception to negotiation completion, including any potential amendments that may occur throughout the life of the project. Using this tool, CFS Contract Team members are able to track many aspects of the negotiation, including project and vendor information, key negotiated items stratified by budget and contract clauses, red-lined agreements with version control, and negotiation status. The CFS Negotiation Tracking System provides an organized and systematic method to track negotiations and facilitate reviews and escalation to the sponsor’s representatives for additional levels of approval and review. Finally, the Negotiation Tracking System is a near-time system that serves as the primary workspace for the CFS Contract Team, thereby enabling full transparency and reporting to the sponsor.