Step 1 of 4 · 2014–21

Patients recruited without a site

Two answers to the site problem

IQVIA attacked slow enrollment by making the existing trial model smarter. In May 2016 Quintiles, a CRO, agreed to merge with IMS Health, a healthcare data company, with the stated aim of improving trial design, recruitment and execution using IMS's patient information SCIX-9. By 2021 the combined company, IQVIA, held more than 1.2 billion non-identified patient records and used analytics for site identification and patient recruitment SCIX-4. Sponsors could keep their CRO and their procedures and still get better site choices and patient lists.

Science 37, founded in 2014 by Noah Craft and Belinda Tan, who served as its chief executive and chief medical officer, attacked the site itself SC1. It recruited patients independent of any site, often through media or referrals from patient groups, providers and pharmacies, and served them at home through its own telemedicine investigators, mobile nurses and remote coordinators working on one technology platform SC1. By early 2022 it reported more than 100 trials executed and over 500,000 patients engaged SC1. Sponsors bought the work of running the trial along with the software, which spared them assembling those pieces SC1. The same choice put Science 37's own staff and money behind each study: some trials required large upfront spending on patient recruitment that sponsors did not always repay SC1. David Coman, formerly IQVIA's chief marketing officer, became chief executive in November 2019, and the company settled with both founders in June 2020 SC1.

Rivals IQVIA combined Quintiles' trial operations with IMS Health's data in 2016 and by 2021 used more than 1.2 billion patient records to choose sites and find patients SCIX-9 SCIX-4.

Tech-Enabled ServicesM&A Strategy

Step 2 of 4 · 2020–22

A virtual site inside CRO-run trials

Many of IQVIA's decentralized trials launched in 2020, as the pandemic disrupted studies, inside trials it already managed. It offered telehealth, virtual site management, home health nursing and direct-to-patient engagement, and let sponsors choose fully virtual or hybrid designs SCIX-3. By March 2021 more than 60 registration trials in over 40 countries used these services, IQVIA had enrolled more than 150,000 subjects since starting the work, and it ran Johnson & Johnson's late-stage COVID-19 vaccine test virtually SCIX-3 SCIX-2. By October 2021, 30% of IQVIA's studies used at least one decentralized component, and 89 ran fully on its platform for 34 sponsors SCIX-8. A sponsor could add home visits without hiring a second company.

Science 37 had positioned itself as that second company. It offered full decentralized trials, served as a "Metasite" handling part of the patients in a trial run through traditional sites, or licensed its technology alone SC2. It chose to grow through the CROs: "Science 37 views CROs as partners and a sales channel" SC2. PPD, a CRO that was also a beneficial owner of Science 37, supplied 22.9% of its 2021 revenue SC1. In May 2022 CEO David Coman credited CRO partnerships for a record pipeline SCIX-7. Some CROs already called Science 37 a competitor SC2. In April 2022 PPD, by then owned by Thermo Fisher, folded Matrix Clinical Trials' mobile research sites and virtual investigator network into its own hybrid and decentralized portfolio, and in October 2022 it launched a network of DCT-trained sites with the stated aim of becoming customers' preferred DCT partner SCIX-14 SCIX-13 SC2. Science 37's revenue from PPD fell from $13.7 million in 2021 to $6.9 million in 2022 SC2.

Rivals IQVIA offered decentralized and hybrid designs inside its own full-service trials, used in 30% of its studies by October 2021 SCIX-8 SCIX-3.

End-to-End Workflow