PPD® Functional Service Partnership (FSP) Site Contracts and Payments (SC&P) Solutions
the right solutions for fast and efficient site contracting and payment processing
As biotech, biopharmaceutical and medical device organizations face growing pressure to accelerate therapeutic development, accelerating site contracting cycle times helps you get your clinical trial sites activated and up and running sooner, while ensuring site payments are accurate and on-time helps you become a sponsor of choice.
PPD® Functional Service Partnership (FSP) site contracts and payments (SC&P) solutions combine clinical trial contract best practices, local knowledge and know-how, and proprietary robotic process automation (RPA), artificial intelligence (AI), natural language processing (NLP), and machine learning (ML) tools to provide the breadth and depth of expertise you need for fast and efficient site contracting. In addition, our dedicated teams leverage their global and local expertise to navigate the nuances of regional site payment requirements and deliver timely and precise payment processing and management.
Whether you need a full site contracts and payments solution or highly skilled staff to complement your existing capabilities, we leverage our proven track record and extensive global experience to deliver customized solutions tailored to your requirements – while providing much needed resource flexibility, reliability and continuity.
Our site contracts expertise,
by the numbers
- More than 8,000 primary contracts per year
- More than 2,100 ancillary agreements per year
- Approximately 7,000 amendments per year
- Approximately 600 trials supported in 66 countries
- 61% of clinical trial agreements (CTAs) delivered with cycle times below our median
- Less than 20% of site issues escalated
Our site payments expertise,
by the numbers
- Bulgaria (main FSP hub)
- United States
- Mexico
- Philippines
Proven expertise and support for your site contracting needs
PPD FSP SC&P solutions support tens of thousands documents annually for all clinical trial site contracting needs. From initial contracts to ancillary agreements and amendments, our solutions help reduce your cycle times. Our expertise includes the following areas:
- Preparation of legal language templates and documents: creation of contract documents using PPD templates, client templates, a combination of the two, and governmental, industry, or sites’ own templates
- Generation of clinical trial agreements: creation of site-specific clinical trial agreements using previously generated contract documents, in addition to country budget information
- Site-level negotiations: management of site-level negotiations with a minimal number of direct contacts in the correct time zone and language, considering local professional and cultural practices
- Escalation of site contracts: establishment of clear communication and escalation pathways to successfully complete contract site negotiations, accurate tracking of negotiations, and review of site requests
- Fair market value development/review: use of Medidata Edge Site Grants for determination of grants’ fair market value; fair market value considerations are based on demographics, geographic location, institution type and protocol specific requirements
Leverage best practices and regional expertise to accelerate your site contracting
To expedite your site contracting, we combine clinical trial contract best practices with the local expertise of specialists from around the world. To navigate country-specific nuances and proactively identify, anticipate and mitigate contracting challenges, we employ a mix of local experts with specialized, in-depth knowledge and expertise, country-specific regulatory intelligence from our proprietary RegView system, and oversight from regional generalists and centralized roles.
Specialized roles to deliver your site contracts on time
For site contract process oversight, our contract managers serve as a single point of contact for all contract-related issues and oversee the work of the entire contracting team. Our contract managers are selected based on their exceptional management skills, and they work closely alongside your contracting or legal point of contact to aid in decision-making and escalation.
For budget-related items, our investigator grant analysts serve as a single point of contact and work alongside clinical management and legal staff to discuss budgeting and implement changes throughout a study.
For escalations arising from site negotiations, contract managers and investigator grant analysts work closely to address issues promptly.
For local support, our contract specialists handle country-specific, site-level negotiations and work in your site’s time zone and local language. Armed with in-depth, local knowledge, contract specialists are integral in providing real-time updates to key stakeholders, negotiating agreements on behalf of sponsors, and are key to accelerating site contracting timelines.
PPD FSP SC&P solutions teams also actively address growing industry resource needs by identifying and embracing “early career” hires with transferable skills developed in other functional areas. Our global reach provides access to an expanding talent pool, allowing us to hire from nearly anywhere in the world with opportunities to work remotely. With competitive rates to attract top-notch talent and a commitment to career development, we focus on recruiting the right talent to help fulfill your project’s site contracting needs.
Dedicated teams with global expertise deliver accurate and on-time site payments
Our site payments solutions employ dedicated teams with specialized functional expertise to deliver accurate and on-time site payments.
Through specialized support functions and staff located throughout the world, our site payments group provides both payment processing and management services with the expertise needed to navigate the nuances of regional payment requirements. Using a unified and interconnected team structure, our experts collaborate across the duration of a study to precisely and efficiently complete payment tasks on time. Our support encompasses the following functional areas:
- Site payments
- Subject visit template (SVT) review
- Ethics committee and regulatory authority payments
- Payment processing
- Payment accruals and reconciliation
- Funds management
- Payables
- Transparency reporting
- Administration
A two-pronged approach ensures accurate and timely payments
Within our site payment solutions, well-established internal controls are utilized to maintain separation between payment processing and payment approval tasks. Before payments can be issued, they must first undergo a formal review and approval process, incorporating multiple layers and system controls. Quality checks are also embedded throughout the payment processes to ensure our site payments team issues accurate and timely payments.
Our two-pronged approach to the oversight of payment processes extends to both the operational management and leadership levels. This maximizes communication and escalation pathways to quickly engage leadership for additional assistance and strategic support with issue management, contingency planning and/or risk mitigation.
Customizable systems and processes power flexibility
Using a customizable mix of systems, processes and oversight – yours or ours – we quickly identify the best engagement model for each client’s needs. Our solutions offer the flexibility to either embed staff within your workforce using your existing infrastructure, SOPs and processes, or take the business fully in-house using PPD SOPs, processes and systems.
In addition, our innovative pricing models can also accommodate various contract structures, from full-time equivalent (FTE), unit-based, time & materials, and hybrid models. These flexible models can be tailored to evolve with changing client needs over time.
For engagements utilizing PPD systems and procedures, we leverage our knowledge and expertise to identify and utilize proven processes and tools to meet timelines and maximize speed and efficiency.
In-house tools enable you to save time and money
Our in-house site contracting (RPA, AI and NLP-based) tools drive faster contract execution by more accurately predicting country-specific and site-specific contracting timelines and streamlining site negotiations, budget development and reporting, and risk identification and mitigation.
Examples include:
- Preclarus® interactive dashboards of operational data
- Preclarus® for site contracting progress
- Site Contracts Analytics and Negotiation (SCAN) tool
- Medidata Edge Site Grants
- Budget Quality Assurance (BQA)
- Digital Assistant (DA) RPA tool
- Oracle Activate
- MAD DASH RPA tool
Our in-house site payments tools accelerate site study budget entry (ensuring compliance with Sarbanes-Oxley (SOX) controls timelines), payment inquiries response times and payment processing cycle times. We achieve this by streamlining site agreements receipt by site payments teams, site budget entry and approval, payment related tasks assignment and payment details reporting.
Examples include:
- Preclarus® for Site Payments
- Ticketing system
- MAD DASH 2 RPA tool
- PDR (Payment Details Report) RPA tool
- Admin RPA tool
- Budget Entry and Approval tool
- Reconciliation Tool
- Transparency Reporting Tool
Contact us
Ready to make faster and more efficient decisions to meet your timelines? Connect with us to learn how PPD FSP site contracts and payments solutions help you accelerate site contracting cycle times and deliver accurate and on-time site payments.