PPD Functional Service Partnership (FSP) Project Delivery Solutions
We cover all aspects of project management, including:
- Project planning: Lead development and communication of project plans using either client or PPD templates; organize cross-functional strategic input on protocol or project design from experts in regulatory affairs, statistics, therapeutic areas or other areas as needed.
- Project communications: Conduct face-to-face meetings, teleconferences, status reports and project updates per the approved project plans(s) to keep stakeholders informed and ensure project activities stay on schedule
- Audit readiness: Develop audit readiness plans that include information on the project team managers, training compliance, project SOPs, project plan currency and project reporting that are reviewed at regular intervals; oversee training and execution of plans across departments
- Issue escalation and management: Follow PPD issue escalation process to review projects at defined intervals, triaging issues for review and mitigation to support successful project execution; create well-defined touchpoints and escalation pathways to ensure needs are addressed quickly
- Vendor management: Manage vendor timelines, performance and deliverables to assess risks, quality trends and finances, and ensure accurate project timeline forecasting and launch; provide a working practice document to address conflict of interest concerns
- Financial management: Conduct monthly finance status meetings and apply appropriate control measures (e.g., monthly checks on data currency and accuracy and data analysis for trends and financial risks); use a single project finance platform to which all relevant parties have access
- Project-specific training: Create training plans and subsequent study staff training on scientific, therapeutic and clinical aspects of the indication, and client procedures used in projects to ensure compliance
Expert Problem-solvers, Communicators and Collaborators
Drive Accuracy and Efficiency
Strong leadership and a collaborative team culture drive your success
We understand that quality people driving projects is key to success. PPD Project Delivery leads are:
- Client-focused problem-solvers and effective communicators with excellent customer service skills, enabling them to understand and fit seamlessly into your team’s culture and development goals
- Chosen for their project management expertise and ability to assess and assign priorities to tasks and identify potential risks
- Adaptable and strategic thinkers who plan for the future and pivot quickly to ensure your projects are successfully completed on schedule when challenges arise
- Selected for their exceptional customer service skills, which are further enhanced and refined through continued training, coaching and evaluation
- Regularly share best study management practices within the team to aid in project delivery and have access to case studies
More than just project managers, our Project Delivery leads are also experienced in all phases of clinical development and protocol design, including:
- Project launch
- Database lock/close-out
- Phase I to III and peri- and post-approval studies
- Regulatory affairs
- Specific therapeutic areas/technical expertise
Overseeing our Project Delivery leads are FSP-dedicated people managers equipped with knowledge and expertise in project management and client-embedded work situations. These managers are specially trained and experienced to support on-time project delivery, while ensuring accuracy and flexibility throughout the process. Our FSP infrastructure is also designed with minimal managerial layers, providing direct access to executive sponsors. This allows us to maximize efficiency and responsiveness, streamlining communication.
Flexible Project Delivery Solutions Tailored to
Your Specific Needs
Our extensive Project Delivery expertise is cultivated from flexibly delivering all types of FSP engagements. Using best practices and lessons learned from our extensive experience, we’re able to quickly identify the best engagement model for each client’s needs, including a customizable mix of systems, processes, oversight and facilities – yours or ours – and the flexibility to embed staff within your workforce or take the business fully in-house.
Our innovative pricing models accommodate various contract structures from full-time equivalent (FTE), unit-based, time & materials, and hybrid models, and these flexible models can be tailored to evolve with your changing needs over time.
Whether working within your systems or ours, our dedicated resources align to your culture and values
At the start of each engagement, we apply a “one-team” approach to integrate our Project Delivery strategies with your goals and key performance indicators. We align on clearly articulated roles and responsibilities, communication and feedback processes, defined escalation pathways, and recurring governance meetings to proactively identify and mitigate risks and enable you to reach your targets quickly and efficiently.
When working in your SOPs, guidelines and/or IT systems, our staff work with you to ensure that training is properly completed to facilitate successful onboarding and integration with your team. We also collaboratively develop an engagement handbook that details all program documentation.
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 areas, including:
- Validated systems (e.g., clinical trial management systems, Veeva Vault)
- Team member training
- Defined, global processes (e.g., project plans, procedural documents)
- Risk-based quality management training (e.g., centralized monitoring, risk management and escalation) that is fully compliant with ICH E6 r2
- Non-compliance management (e.g., handling of quality events including root-cause analysis and corrective and preventive actions)