Challenging the Status Quo: Reimagining the Tech and Processes That Support Site Activity

Learn about three core ways our platforms and process enhancements are driving new capabilities.

As the PPD™ clinical research business of Thermo Fisher Scientific began to strategically focus on enhancing the experience for both investigators and sites participating in our clinical trials, aligning the proper technology to address common pain points was a key focus. Sites frequently describe challenges with an overwhelming array of different sponsor and site systems, requiring change management and technical support. To truly enhance their experience, technological solutions would need to be aligned to real site challenges, easily adopted and properly supported.

To achieve these goals, we’ve focused on driving solutions in three areas: how sites are paid, how our sites are supported and trained, and how our sites secure study matches.

1. How our sites are paid

We recognize the industry imperative to streamline site payments, ensuring they are fast, accurate and transparent. But many sponsors and contract research organizations (CROs) are using outdated systems that do not speak to each other, placing a high administrative burden on their staff and the sites they are paying.

To address these challenges, we are collaborating with Ledger Run Inc. to use their integrated ClinRun system for managing site payments. Benefits of this cutting-edge new system include:

• Greater customer and site satisfaction
  • An improvement in site payments activities leads to greater satisfaction by ensuring timely and accurate payments with minimal administrative burden, along with customer- and site-facing visibility that improves transparency and collaboration for sites and investigators.
• Reduced burden
  • As a result of faster payments, clear transparency to payment workflows, reduced clinical research associate (CRA) involvement in payments processes and elimination of dual entry, site payment colleagues can focus on their studies and become a stronger site payments liaison between the business, our customers and clinical research sites.
• Increased speed of payment
  • Validation of payments data will be automated, instead of waiting on activities by other groups. New processes will minimize handoffs and speed up payments.

We are pairing the ClinRun system with our internally developed EDC Hub that provides flexibility and efficiency in how we can digest EDC (Electronic Data Capture) data and prepare for triggering automated site payments.

Together, these new investments will streamline and improve how we are able to pay sites.

2. How our sites are supported and trained

The entire clinical research landscape benefits from a growing ecosystem of new sites entering research and experienced sites expanding their capabilities. But finding reliable, high-quality training to enable these sites has been historically difficult.

To address these challenges, we have created SiteCoach, a single training interface to offer comprehensive training for sites, including:

• Virtual live training for research naïve sites delivered via Microsoft Teams
• Self-paced e-learning classes (e.g., decentralized trials certification, patient diversity in clinical trials, etc.) delivered via our learning management system

This solution is designed to support investigational sites on their path to excellence by coaching each staff member to become a successful contributor to the conduct of clinical trials. To date, the platform has helped train over 300 participants from more than 55 sites in over 12 countries.

3. How our sites secure study matches

One of the key challenges faced by many sites is identifying and accessing studies that fit within their capabilities and interests. Historically, this has been a manual, disjointed process of seeking out potential studies and reviewing study-specific questionnaires.

Sponsors and CROs, meanwhile, tend to direct new study opportunities to the sites with the most experience. This creates a cycle in which most trials are conducted at a small proportion of the available sites. This leaves out a very large number of experienced sites that do not get as many opportunities to participate in clinical trials, and it can be challenging for CROs and sponsors to identify the best sites to approach from this large pool of sites based on experience data alone.

To address these challenges, we are collaborating with the Inato marketplace. This marketplace is free for sites and flips the traditional feasibility model, allowing sites to review, apply for and get selected for trials that are the best fit for their capabilities and patients. Within the marketplace, sites can either see all available trials, or fill out an interest and capabilities form, which utilizes AI-enabled matching algorithms to align them with the right clinical trials.

The Inato marketplace:

• Empowers sites to take more control of their research portfolio. By self-selecting the studies that are of interest to them, sites can plan their research pipeline more efficiently, rather than manually seeking out studies or waiting to be contacted by a sponsor or CRO.
• Reduces traditional feasibility burden of needing to review an entire questionnaire; feasibility becomes a step-by-step approach in that sites can review preliminary requirements and, if interested, quickly apply with pre-filled applications that are verified by source data.
• Results in increased site diversity, particularly with access to more community sites, and results in more engaged sites, as the model is site-centric.
• Improves site experience, with 95% site satisfaction reported in Inato analytics

In summary, potential research sites receive faster, easier and broader access to trials.

Enhancing the investigator experience

By focusing our technology investments on the challenges facing sites today, working with leading-edge companies like Inato and Ledger Run and employing programs such as SiteCoach, we can improve the site and investigator experience and get more sites involved in clinical research. The end result is a stronger ecosystem to support the delivery of life-changing therapies to patients.