FSP Clinical Operations Solutions

Clinical Research Associates (CRAs)

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.

Clinical Trial Coordinators (CTCs)

Provides local support including trial master file (TMF) setup and management, handling of site-initiated amendments, reviewing regulatory documents and disseminating study information.

Country Approval Specialists

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.

Site Contract Specialists

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.

Site Engagement Leads

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.

Central Review Managers

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 the PPD 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:

The PPD 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 the PPD CRA Academy is equivalent to CRAs who joined us as experienced CRAs.
The PPD 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 125 new CRAs who are now working across seven 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.
The PPD 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, PPD-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 PPD 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% globally²

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

• 9+ years of experience • 5,600 analysis and review cycles

PPD is recognized as one of the best global enterprise learning and development programs in the world

by the Association for Talent Development³

² 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.

The clear choice for your FSP clinical operations needs

Whether you require specialized skills to complement your existing expertise or an outsourced solution to perform all aspects of clinical monitoring and site management, PPD Functional Service Partnership (FSP) Clinical Operations Solutions delivers customized solutions to keep you on schedule, while providing much-needed resource flexibility, reliability and continuity – all offered with the convenience of working with a single global partner.

PPD^® Functional Service Partnership (FSP) Clinical Operations Solutions

The global expertise you need to ensure patient safety, data quality and protocol compliance

Fill your gaps through our breadth and depth of therapeutic and functional expertise

Problem-solving professionals and flexible delivery models ensure you stay on schedule

Comprehensive clinical operations solutions deliver resource flexibility, reliability and continuity

1. Global reach powered by a strong recruitment engine

2. Clinical operations training

3. Ongoing development, engagement and retention strategies ensure on-time delivery

A global network of dedicated professionals

Why choose PPD as your FSP partner?

Leveraging decades of clinical operations experience creates the best outsourcing model for your needs

The clear choice for your FSP clinical operations needs

Contact us

PPD® Functional Service Partnership (FSP) Clinical Operations Solutions

The global expertise you need to ensure patient safety, data quality and protocol compliance

Fill your gaps through our breadth and depth of therapeutic and functional expertise

Problem-solving professionals and flexible delivery models ensure you stay on schedule

Comprehensive clinical operations solutions deliver resource flexibility, reliability and continuity

1. Global reach powered by a strong recruitment engine

2. Clinical operations training

3. Ongoing development, engagement and retention strategies ensure on-time delivery

A global network of dedicated professionals

Why choose PPD as your FSP partner?

Leveraging decades of clinical operations experience creates the best outsourcing model for your needs

The clear choice for your FSP clinical operations needs

Contact us

PPD^® Functional Service Partnership (FSP) Clinical Operations Solutions