Gantt chart project timeline

PPD Functional Service Partnership (FSP) Study Startup Solutions

Uncover the right solution to meet your site activation timelines

Launching sites on schedule is critical to meeting clinical trial timelines and ensuring strong relationships with sites. PPD® Functional Service Partnership (FSP) Study Startup (SSU) solutions help biotech, biopharmaceutical and medical device organizations meet their site activation timelines by delivering SSU solutions through a flexible FSP model

Our solutions deliver the proven breadth and depth of expertise you need to identify the right sites, streamline and expedite study startup, and launch your sites on time. We assemble a team of experienced problem-solving professionals to solve your study startup challenges and apply customized solutions tailored to meet your specific study startup needs. 

Whether you need a team of country-specific specialists or help filling specialized capability gaps, PPD FSP SSU solutions leverage our global expertise across more than 50 countries to help ensure smooth activation of your sites worldwide – while providing much-needed resource flexibility, reliability and continuity. 

Our Study Startup Capabilities,
by the Numbers 

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More than 30 years of study startup experience

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More than 450 startup leads supported by more than 1,400 locally based startup specialists across more than 50 countries

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30% faster site activations and 2.5 times more patients enrolling at PPD Select Sites (compared to traditional sites)

Proven study startup expertise to launch your sites on time

Fast and efficient study startup begins with strong feasibility and site identification. PPD FSP SSU solutions help you identify the optimal strategies, countries and site mix, streamline operational processes, optimize cycle times, and – most importantly – launch your sites on time. For each engagement we support, our solutions are tailored to each client’s needs to help ensure strong relationships with sites and provide support in areas including:

  • Startup strategy and planning: Define and develop the site profile and activation path, utilizing data-driven forecasting for site activations.
  • Site selection and activation: Perform country and site selection, compile required documentation and negotiate site contracts.
  • Coordination of submission activities: Submit necessary forms to the appropriate regulatory agencies and ethics committees and draft master informed consent forms.
  • Documentation support: Collect and distribute project documents (e.g., protocols, Investigator’s Brochures, informed consent forms and investigational medicinal product dossiers).
  • IP, systems and vendor setup: Engage with project leads and clinical trial managers to ensure timelines are met for items including investigational product, lab kits, ancillary supplies, critical path items and trade compliance.

Our long-standing experience and expertise in activating studies enable accelerated timelines, amplified enrollment with fewer non-enrolling sites and increased efficiency. Additionally, through our PPD Select Sites, we leverage the strategic relationships we’ve cultivated to ensure the prioritization of PPD studies and accelerate study startup using pre-existing confidential disclosure agreements (CDAs) and master service agreements (MSAs). Assistance for on-site administrative tasks is also available through PPD FSP Site Support solutions to help unburden site staff and ensure you meet your site activation timelines.

Experienced problem-solving professionals to solve your study startup challenges

In every engagement, we bring together a team of experienced managers and country-based specialists. Each one has a dedicated role in your study’s startup and brings a customer-first, problem-solving mindset to solve your specific challenges.

Global startup team managers (GSTMs) support initial startup activities, coordinating development of a comprehensive startup strategy alongside project and functional leads across project management, regulatory affairs, strategic feasibility, global clinical supplies and clinical team management. This role is accountable for the development of the study startup plan and site activation forecasts, builds and leverages relationships with local experts and agencies, and ensures oversight of all study startup activities.

GSTMs also work with regional startup team managers (RSTMs) who drive regional site activation by working with local teams (e.g., contract specialists and country approval specialists). With extensive regional knowledge of local languages, regulatory practices and cultural needs, our locally based startup specialists support site selection, regulatory and ethics activities, collection of essential documents and site contracts negotiations to ensure smooth site activation worldwide.

Our commitment to rapidly onboarding new team members and educating and upskilling our employees also ensures consistency and compliance, expands skill sets and provides training for future needs. For example, we include standardized training curricula for every role on the team, processes for assessing training completion and compliance, specialized training around client systems and standard operating procedures, and people managers aligned to support resource and performance management.

Tailor-made solutions to meet your specific study startup needs

With decades of study startup experience, we apply best practices and lessons learned to create the best outsourcing model for your needs. Through a customized mix of systems, processes, oversight and facilities – yours or ours – we provide the flexibility to embed staff within your workforce or take the business fully in–house using our innovations and technologies. 

Additionally, we provide dedicated resources aligned to your culture and values. 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 your changing needs over time. 

At the outset of each engagement, we develop a comprehensive implementation plan and apply a “one team” approach, integrating your goals and key performance indicators (KPIs) with our proven study startup strategies (in areas ranging from sourcing talent to induction, operational handbooks and onboarding materials). We also clearly articulate and set roles and responsibilities, communication and feedback processes, defined escalation pathways and recurring governance meetings to proactively identify and mitigate risks, helping you quickly and efficiently reach your target. 

For engagements using our systems and procedures, we leverage our knowledge and expertise to identify and use proven processes to maximize speed and efficiency and meet timelines. We also fully leverage the following technologies to increase quality and reduce timelines, including the use of proprietary systems, robotic process automation and machine learning or artificial intelligence (AI) technologies to improve site activation and trial timelines: 

Preclarus® Dashboards
Displays cross-functional view of study startup activities, countries and sites to provide end-to-end visibility and progress against contractual goals and capture all tracking and communications in a single client-accessible system.
ORACLE Activate Supports site startup and maintenance through fostering collaboration and communication through a single source, limiting the manual management and manipulation of documents, and providing metrics reporting to identify opportunities to streamline processes, eliminate errors and accelerate activation timelines.
Veeva TMF/ Quality Ensures compliance with eTMF (sponsor or internal) through collaboration between study startup and local teams to always maintain inspection readiness.
Global Site Contracts Digital Assistant (DA) Provides standard information (sponsor, drug name, etc.) in country-specific templates to minimize human error and expedite form generation.
Budget Quality Assurance (BQA) tool Uses robotic process automation to identify discrepancies between site and country budgets to reduce review time and expedite final budget reviews prior to contract execution.
Predict Activation Dates tool Uses data, including historical site performance, to predict when a site is likely to be activated; tool can be rerun as delays or issues (e.g., protocol amendments) arise to predict the new activation date to improve planning and decision making.

Contact us

Ready to tap into the breadth and depth of expertise you need to meet your site activation timelines? Connect with PPD FSP Study Startup solutions to leverage our global expertise and customized solutions tailored to meet your specific study startup needs.