PPD Functional Service Partnership (FSP) Clinical Operations Solutions
The global expertise you need to ensure patient safety, data quality and protocol compliance
The PPD™ clinical research business of Thermo Fisher Scientific supports biopharmaceutical, biotech and medical device organizations through our bespoke clinical operations solutions available in a flexible functional service provider (FSP) model to meet your unique needs.
Fill your gaps through our breadth and depth of therapeutic and functional expertise
Our experienced clinical operations professionals are uniquely positioned to deliver the right experience and knowledge to fill your clinical operations gaps across a full range of services.
Follow clinical monitoring plans using a customized combination of central, remote and on-site tools to ensure patient safety, data quality and protocol compliance.
Facilitate high-touch communication between your client, project team and sites throughout all phases of a study to assure efficient and reliable site management.
Oversee protocol adherence, patient safety, process efficiency and trial delivery and contribute to standardization and consistency across studies, countries and regions.
Provide trial master file (TMF) system setup and support, site operational support, preparation and coordination of local regulatory submissions, investigational drug supply and protocol support, and oversight of contract negotiation and finalization with sites.
Enhance performance through development and management of strong site relationships, non-protocol related oversight of quality across studies and clinical team advisement on study-specific site selection, management strategies and best practices.
Problem-solving professionals and flexible delivery models ensure you stay on schedule
Our clinical operations staff is on the front line of new operating models rooted in risk-based quality management (RBQM) and data analytics. Our experts are trained with a RBQM mindset to apply risk-based approaches, root cause analysis, critical thinking, and problem-solving skills to proactively identify specific issues and focus on expedited resolution to mitigate the risk for business disruption.
Our flexible role mapping process allows us to align our experts to your internal structures, providing you support across all stages of your trials.
From study startup and enrollment to ongoing maintenance and study close-out, we provide a wide range of far-reaching clinical operations roles and responsibilities.
Performs clinical monitoring and general site management tasks in all stages of a clinical trial life cycle, and provides support for regulatory audits, inspections and safety reporting.
Provides local support including trial master file (TMF) setup and management, handling of site-initiated amendments, reviewing regulatory documents and disseminating study information.
Provides local support with regulatory submissions and guidelines, ensures alignment to critical path for site activation, develops country-specific informed consent forms and assists with site budget and payment schedule negotiations.
Assists with contract development, negotiation, and finalization, identifies legal, financial, and operational risks and escalate as required, and ensures site startup and contractual activities are aligned to achieve target cycle time for site activation.
Helps you gain position as a sponsor of choice with study clinical teams, overcomes execution roadblocks, advises on study-specific site selection or site management strategies, and drives standardization across studies, countries and regions.
Provides local support and review and approval of monitoring visit reports, ensures consistency in monitoring visit reports across protocols and countries and escalates issues, and evaluates PI oversight, subject safety and study process.
Comprehensive clinical operations solutions deliver resource flexibility, reliability and continuity
Backed by a 25+ year track record of FSP support, our comprehensive clinical operations solutions are staffed by problem-solving professionals – and powered by flexible delivery models – to ensure accelerated end-to-end execution of your studies.
Our staff and solutions are backed by the full force of our clinical research team’s global infrastructure, resources, and access to specialized therapeutic, functional, and operational experts. To maintain high staff engagement and consistently low turnover rates (well below industry averages), we use a three-pronged approach to attract, train, develop and retain talent.
1. Global reach powered by a strong recruitment engine
Training continues upon completion of our programs with ongoing investments in our team to enhance soft skills, increase technical competencies, and help facilitate personal/professional growth with real time peer support, additional drop-in group training sessions, and graduated study assignments. Our professional development and learning culture increases engagement and retention and, in turn, encourages the recruitment of other professionals who we allocate and onboard quickly across multiple time zones to keep your study on schedule.
2. Clinical operations training
On top of the rigorous ongoing training that our clinical operations staff receive, we offer three innovative training programs:
- Our CRA Academy uniquely gives highly motivated entry-level CRAs with a life science degree the opportunity to develop and transform into highly qualified CRAs in high global demand. The CRA Academy combines soft skill development, therapeutic e-learning, technology training, instructor-led scenario-based sections, and role playing to prepare CRAs for the challenging situations they may face on-site. With more than 1,000 graduates, performance of employees that participated in our CRA Academy is equivalent to CRAs who joined us as experienced CRAs.
- Our Clinician to CRA Program gives experienced clinicians, nurses and allied health professionals a pathway into clinical research. Since the program’s inception in 2021, C2C has graduated over 350 new CRAs who are now working across multiple client engagements, most typically in therapeutic areas that align with their prior clinical experience. In our experience, the therapeutic and clinical expertise of these professionals translates seamlessly into clinical research and graduates demonstrate performance metrics that are similar or better than their CRA counterparts.
- Our Clinical Development Academy is creating the clinical research workforce of the future by casting a broad net, selecting the best and brightest talent based on competency rather than experience, and building a diverse, trained talent pool. By equipping our professionals with the skills, experiences and resources they need to succeed, we provide our clients with access to highly competent professionals capable of delivering on current needs and innovating for the future.
3. Ongoing development, engagement and retention strategies ensure on-time delivery
Training continues upon completion of our programs with ongoing investments in our team to enhance soft skills, increase technical competencies, and help facilitate personal/professional growth with real time peer support, additional drop-in group training sessions, and graduated study assignments. Our professional development and learning culture increases engagement and retention and, in turn, encourages the recruitment of other professionals who we allocate and onboard quickly across multiple time zones to keep your study on schedule.
A global network of dedicated professionals
Why choose us as your FSP partner?
130+ recruitment professionals
with dedicated FSP staffing team
Low 13.7% FSP staff turnover
compared to industry average of 21% as of March 2023
Consistently low CRA turnover rates
15% in the US and 11.4% outside the US compared to 24% in US and 20% globally1
Excellent feedback scores on CRA recruitment effectiveness
• Quality of hire: 92% • Manager satisfaction: 89% • New Hire satisfaction: 90%
Centralized monitoring and risk surveillance analysis expertise
• 10+ years of experience • 7,000 analysis and review cycles
We are recognized as one of the best global enterprise learning and development programs in the world
by the Association for Talent Development2
1 CenterWatch Weekly March 1, 2021 (BDO 2020/2021 CRO Insights Report)
Leveraging decades of clinical operations experience creates the best outsourcing model for your needs
Our solutions provide the flexibility you need to blend your workforce with our exceptionally trained staff through customizable systems, processes, oversight and reporting structures.
We allocate and onboard staff quickly across multiple time zones to keep your study on schedule, applying best practices and lessons learned to create bespoke, high-quality partnerships.
Alternatively, we can take your work fully in-house using our innovations and systems. For example, our 360-degree monitoring model delivers a combination of continual remote, on-site and centralized monitoring, aimed at reducing reliance on episodic on-site monitoring and making site monitoring and data review a continual, real-time process.
Our innovative pricing models can 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 your changing needs over time with built-in agility to rapidly adjust resource levels to keep pace with your growth or portfolio changes.