Meeting the Challenge of Evolving Site Models
Areas where we are leaning in and changing conventional ways of working to enhance the investigator experience
Over the last decade, the clinical research industry has seen investigator site models evolve, pushing contract research organizations (CROs) to think and collaborate more creatively. Today’s sites span a full spectrum — from traditional sites dedicated exclusively to research, all the way to new community practices and decentralized options. Their unique characteristics can sometimes create complexities when executing clinical research and therefore need careful attention when planning for a study.
According to site surveys conducted by WCG Clinical Services in 2022-2023, staffing, trial enrollment, and budget and contracts were the top three issues plaguing sites. To help address some of these, the PPD™ clinical research business of Thermo Fisher Scientific has carved out two areas of priority and action for working with sites.
1. Streamlined budget & payment processes
One area that will improve site satisfaction is streamlining the investigator payment process through process optimization and technology. The goal of this type of financial support by the CRO is to ensure that sites and investigators are compensated fairly and in real time for their work, eliminating unnecessary delays.
To achieve this, a redesign of systems, processes and roles associated with budget creation, forecasting and site payments can drive greater accountability for accurate and timely payments. We are looking at ways to revise budget modeling, making investments in end-to-end contracting platforms for greater visibility and transparency and ensuring accurate payments based on electronic data capture (EDC) data. In the last year alone, we have extensively evaluated our optimization strategies, focusing on enabling technologies that streamline workflows, provide transparency and ensure timely payments, thereby addressing cash flow concerns for sites.
2. Augmenting and supporting site capabilities
As sites and investigators decide how and where to invest their time, it is crucial for CROs to introduce innovative offerings and engagement models to provide more transparency and visibility regarding new and existing clinical trials that may appeal to their experience and interest. Within these solutions, challenges such as site access to clinical trials, staffing and the provision of support to ensure site capacity and capability to deliver clinical trials need to be addressed. Furthermore, careful attention should be given to challenges related to enrollment and the need for a diverse and relevant participant pool.
Finding new sites with the necessary skills and patient populations is becoming increasingly challenging due to a decline in principal investigators joining clinical trials. Furthermore, decentralized and precision medicine trials require additional skills and training of sites, adding to the pressures on the clinical research environment. In many cases, multiple sponsors and CROs have ongoing studies at a single site, leading to numerous complicated touchpoints throughout a clinical trial.
Building strong relationships with investigators and sites that are “clinical research-ready” is crucial in meeting the needs of diverse patient populations globally. It is also important to ensure that the needs of investigators are met to provide a seamless clinical trial experience. We are very active in this space, offering site-focused solutions including strategic partnerships, training and tailored site support solutions designed to enhance site capacity and capabilities.
A differentiated investigator experience
By prioritizing these two areas, we can deliver a differentiated investigator experience, leading to optimized financial and operational support that better addresses site needs, increased patient enrollment and diversity, enhanced site capability for decentralized trials and specific therapeutic area requirements, and improved availability of clinical research-ready sites.
Over the next several months, we will be writing about additional steps that we are taking to enhance the site investigator experience in these and other areas.