Published: September 2023
During the aftermath of COVID-19 pandemic, the pharmaceutical industry witnessed several drug developers entering collaborations with the virtual CROs for utilizing their services and platforms supporting decentralized clinical trials (DCT). We analyzed over 135 service providers that offer decentralized clinical trials / virtual clinical trial services across different regions. In this article, discover 10 virtual clinical trial companies and their capabilities in this industry.
The development of a novel molecular entity, for pharmacological use, is complex as well as cost intensive. It requires close to 10 years and over USD 2.5 billion in capital investment for a prescription therapeutic to traverse from bench to the market. A significant proportion (40%) of the pharmaceutical R&D budget in the US is spent on clinical research, evaluating the safety and efficacy of novel therapeutic interventions in human subjects. Conducting clinical trials is fraught with several challenges, including (but not limited to) patient recruitment related concerns, inadequacies in handling (generation, logging and processing) clinical data, risk of failure (mostly owing to safety concerns and side effects of the drug / therapy being evaluated), and unforeseen delays leading to deterrence from predetermined completion timelines. In fact, retrospective studies have demonstrated that, in over 90% of the cases, clinical trials are delayed due to the inability to either recruit or retain the required number of patients.
The concept of virtual clinical trials, also known as siteless clinical trials or decentralized clinical trials, is one among the many developments in the modern pharmaceutical industry. The virtual clinical trials companies enabled therapy developers / trials sponsors to address some of the exigent concerns related to clinical trial conduct and offered the means to resume clinical research even during the pandemic. Presently, there are several virtual contract research organizations offering a wide range of services and solutions for conducting and managing various aspects of clinical trials. Further, by allowing sponsors / trial affiliates to become more patient centric, improving the reach of clinical trials to wider pool of patients and reducing the workload of trial investigators, the decentralized clinical trials market will continue to witness growth beyond pandemic. There are several start ups that have emerged in the last 3-4 years to offer services related to decentralized clinical trials like Annex Research Solutions, CareShare and xCures. However, the established contract research organizations have expanded their offerings to virtual clinical trial related services. Several other pharma giants namely Boehringer Ingelheim, Bristol Myers, Modera, Otsuka, Pfizer, Sanofi and Squibb, have been actively engaged in using decentralized clinical trial technologies to facilitate the conduct of their trials.
Roots Analysis has conducted an exhaustive study on Decentralized Clinical Trials / Virtual Clinical Trials Market featuring the current market landscape and future opportunity for the service providers involved in offering virtual clinical trial services, over a span of 12 years.
Since virtual / decentralized clinical trials are more patient-centric, this approach not only reduces the clinical drug development timelines, but also addresses the challenge of high capital investments required in the development of pharmaceutical products. The adoption of virtual / decentralized approach by pharmaceutical companies and Contract Research Organizations is believed to alter the trends in the clinical research industry.
Below, we have listed (in alphabetical order), the top 10 Decentralized Clinical Trials Companies / Virtual Clinical Trial Companies transforming clinical research.
1. ICON
2. IQVIA
3. Lab Corp
4. Medpace
5. Oracle
6. Parexel
7. PPD
8. Science 37
9. Signant Health
10. Syneos Health
Interested in exploring all 135+ Decentralized Clinical Trials Companies / Virtual Clinical Trial Companies Offering Services?
This article highlights the top decentralized clinical trials companies to watch out for in the pharmaceutical industry. These established companies were chosen based on their service portfolio strength (based on number of types of decentralized clinical trial services offered). It is essential to note that the selection of top players can differ substantially according to the defined criteria(s).
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ICON offers clinical and consulting services to help support the product authorization requirements of its clients. It helps the pharmaceutical, biotechnology, medical device and government organizations via outsourcing services related to drugs and devices’ development. Within the clinical research sector, ICON is actively advancing their technologies and moving to newer requirements of patients as well as pharma players. In this regard, the company’s expertise includes personalized digital health by shifting from traditional trial model to decentralized trials. ICON offers hybrid model of deploying decentralized clinical trials services.
The company acquired PRA Health Sciences in July 2021 for a sum of approximately USD 12 billion. PRA Heath Sciences was one of the leading CROs driving trial decentralization during the COVID pandemic.
ICON offers following types of decentralized clinical trial services:
Recent Developments Related to DCT Solution:
In March 2023, ICON signed a collaboration with LEO Pharma, where ICON is planning to inculcate its DCT capabilities in the development of new treatments for dermatological disorders.1
Additionally, In June 2023 the company launched an updated version of its Digital Platform, that allows integration of patient, site and sponsor. Further information related to key offerings and phase-related studies is available in the full report.
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IQVIA is one of the leading providers of advanced analytics, contract research services and technology solutions to the life sciences industry. The company leverages data science and analytical solutions for developing novel approaches for clinical development and accelerate advancement in healthcare. Further, the company has capabilities to conduct completely remote or hybrid clinical studies, thereby helping various sponsors to achieve their recruitment goals by identifying the correct patient pool, as well as maximize patient engagement. IQVIA offers fully virtual as well as hybrid model of deploying decentralized clinical trials services.
The company launched its virtual trial solutions in 2018 and as per the fact sheet published by the company in January 2022, IQVIA has conducted more than 300 decentralized clinical trials across 50+ countries.2
IQVIA offers following types of decentralized clinical trial services:
Recent Developments Related to DCT Solution:
The company is also running decentralized clinical trials for consumer health products. In March 2023, IQVIA along with ObvioHealth initiated a fully decentralized clinical trial for an infant goat-milk formula from Jovie USA under the FDA guidance.
In September 2022, IQVIA became the first company to receive TRUSTArc validation for its DCT program, validating its GDPR compliance as per Europe data privacy regulations.2 Further information related to key offerings and phase-related studies is available in the full report.
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Labcorp offers the digitized clinical trial solutions via its technology platform with an aim to reduce the patient and study site administrative tasks as well as improve the trial resiliency. Its CRO business was managed by Covance, which was acquired by Labcorp in 2015. The business changed its name to Labcorp Drug Development in June 2021. Labcorp offers fully virtual model of deploying decentralized clinical trials services. More recently in 2023, the company spin-off its CRO business in to a separate entity which will operate under the name Fortrea.
During its journey to offer decentralized clinical trials, the company also acquired SnapIoT in 2020. The latter had a suite of software and platform to support DCT.
Labcorp offers following types of decentralized clinical trial services:
Recent Developments Related to DCT Solution:
In March 2022, Labcorp extended the collaboration with Medidata for their proprietary technology platform to co-develop digital biomarkers and consolidate their decentralized clinical trial services. Further information related to key offerings and phase-related studies is available in the full report.
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Medpace is a full-service clinical research organization that claims to offer a comprehensive array of clinical development services to both medical device and biopharmaceutical companies. It assists its clients via offering solutions to conduct virtual clinical trials and overcome existing challenges. With its proprietary platform, TrialPACE® ePRO/eCOA/eDiary system, Medpace is collecting patient data participating in decentralized clinical trials. Medpace offers fully virtual as well as hybrid model of deploying decentralized clinical trials services. The company also claims capability to collect and integrate the data from wearable devices in to clinical trials having worked with devices such as rhythm monitors, actigraphy and continuous glucose monitors.3
Medpace offers following types of decentralized clinical trial services:
Recent Developments Related to DCT Solution:
In October 2022, Medpace partnered with FindMeCure’s TrialHub and provided fund to contribute for patient awareness and engagement in clinical research. Further information related to key offerings and phase-related studies is available in the full report.
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Oracle, a cloud technology company is offering its computing infrastructure and software to the various types of companies for the innovation as well as making the operations more effective. In the sector of life sciences, Oracle has supported 250k+ trials till date and now accelerating the clinical studies by integrating decentralized related services for the end-users. Oracle offers eclinical solutions to allow fully virtual clinical trials.
Oracle offers following types of decentralized clinical trial solutions:
Recent Developments Related to DCT Solution:
In October 2022, Oracle collaborated with ObvioHealth to integrate Oracle’s systems with ObvioGo platform to collect, integrate and analyze the data collation from the devices, labs, patients and sites. Further information related to key offerings and phase-related studies is available in the full report.
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Parexel, a leading CRO has implemented various technologies for conducting decentralized clinical trials. Moreover, Paraxel is a founding member of Decentralized Trials & Research Alliance, wherein the focus is to look for newer technologies, research practices as well as policies for the decentralized clinical trial related offerings. Paraxel offers fully virtual as well as hybrid model of deploying decentralized clinical trials services.
Parexel was involved in the first virtual clinical trial, REMOTE which was sponsored by Pfizer and was initiated in 2011. The trial though was terminated in 2012 citing enrollment challenges. Till 2021, the company claimed to have conducted more than 100 decentralized / hybrid clinical trials.4
Parexel offers following types of decentralized clinical trial services:
Recent Developments Related to DCT Solution:
In February 2022, Parexel extended the partnership with Medidata to set new goals for life science sector, focusing on reducing the timelines for clinical research with decentralized clinical trial technologies. Further information related to key offerings and phase-related studies is available in the full report.
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PPD, now part of Thermo Fisher has developed a Decentralized Clinical Trial (DCT) network with a vision to identify sites and investigators for the virtual clinical trials. It was recently recognized by ISG as a leader in the decentralized clinical trial solutions, specific to its design and implementation. PPD offers fully virtual as well as hybrid model of deploying decentralized clinical trials services.
In April 2022, the company collaborated with Matrix Clinical Trials to employ their mobile clinical trials site with clinical staff to identify, recruit and retain clinical trial participants.
PPD offers following types of decentralized clinical trial services:
Recent Developments Related to DCT Solution:
In April 2021, PPD signed a collaboration with Science 37 to utilize the DCT based SaaS platform for remote eConsent, eCOA, eSource and other related services. Further information related to key offerings and phase-related studies is available in the full report.
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Science 37 is a clinical research company focused on the development of networked patient-centric models for clinical research to accelerate the drug development process and reduce clinical trial costs. The firm has entered into various collaborations with national mobile nursing companies, pharmacy chains, virtual e-consenting firms, mobile device companies and patient advocacy groups to provide decentralized clinical trial solutions to its clients. Using the company’s Metasite model, patients and study coordinators are able to connect safely and securely without any geographic limitations. Science 37 offers fully virtual as well as hybrid model of deploying decentralized clinical trials services.
The company was established in 2014 and has since worked with several big pharmaceutical companies to conduct decentralized clinical trials. Science 37 does not use the traditional site-centric approach for clinical trials and as per the August 2023 investor presentation, the company has till date launched 150+ decentralized clinical trials.5
Science 37 offers following types of decentralized clinical trial services:
Recent Developments Related to DCT Solution:
In February 2023, the company acquired a life science platform from Vault Health to enhance the clinical trial workflow capabilities of its Metasite platform. In July 2023, Science 37 partnered with Synlogic to incorporate the technology related to virtual clinical trial for patient enrollment in the Phase III trial for investigational drug labafenogene marselecobac for the treatment of phenylketonuria (PKU). Further information related to key offerings and phase-related studies is available in the full report.
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Signant Health, an evidence generation company, focuses on digitizing systems, which can manage the trial data. The company has designed various tools and technologies capable to reduce patient and site burden via offering end-to-end services for decentralized clinical trials. The SmartSignals ecosystem of Signant Health is assisting the sponsors by incorporating data aggregation solutions, direct-to-patient medication supply and home nurse partnerships. The company’s virtual study solutions enable extraction of clinical research data and generation of valuable insights, thereby reducing the overall cost and time associated with clinical trials. Signant Health offers fully virtual as well as hybrid model of deploying decentralized clinical trials services.
The company been growing its decentralized clinical trials service portfolio through the acquisition of VirTrial in November 2020, followed by recent acquisition of DSG in July 2023.
Signant Health offers following types of decentralized clinical trial solutions:
Recent Developments Related to DCT Solution:
In July 2023, Signant Health acquired DSG for decentralized clinical trial advanced technologies namely electronic data capture (EDC) and direct data capture (DDC). In January 2022, Trial@home had selected Signant Health to develop and standardize tools for the makeover of clinical trials in the European Union.
Further information related to key offerings and phase-related studies is available in the full report.
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Deep insights, agile technology, creative trial design expertise, and operational excellence are the cornerstones of Syneos Health's Decentralized Solutions, which improve product development by bringing clinical trials closer to the patient. The team at Syneos Health is focused on minimizing the patient as well as site burden via offering unique study designs to run the trial. Syneos Health offers fully virtual as well as hybrid model of deploying decentralized clinical trials services.
Syneos Health offers following types of decentralized clinical trial services:
Recent Developments Related to DCT Solution:
In February 2023, Syneos Health launched the Decentralized Clinical Trial (DCT) Site Network to promote proper DCT adoption, facilitate high-quality DCT and digital health technology solutions delivery. Further information related to key offerings and phase-related studies is available in the full report.
The above presentation features ten decentralized clinical trials companies selected from a pool of over 135 players that we have compiled. If you're interested, you can download the Sample Report on this topic by Roots Analysis. For personalized assistance in identifying the most relevant solutions based on your specific criteria, please don't hesitate to reach out to us at sales@rootsanalysis.com.
I am Nancy Kapila, an accomplished pharmaceutical consultant with a rich and diverse experience spanning more than 5 years. My educational background includes a Master's degree in Pharmaceutics (M.Pharm) from Panjab University, which has provided me with a solid foundation in understanding the intricate mechanisms of drugs and their interactions within the human body. Throughout my professional journey, I have had the privilege of working with various pharmaceutical companies, leveraging my expertise to provide valuable insights and strategic guidance.
What sets me apart is my unwavering commitment to staying at the forefront of the ever-evolving pharmaceutical landscape. In an industry characterized by rapid advancements and dynamic changes, I make it a priority to remain well-informed about the latest developments, regulatory updates, and emerging trends. This continuous learning not only keeps me well-equipped to navigate the complexities of the field but also enables me to offer innovative solutions that drive client success. I am deeply fascinated by the potential of data analytics and its transformative impact on decision-making. By delving into data, I can identify patterns, trends, and opportunities that might otherwise remain hidden. This enables me to provide clients with evidence-based recommendations that optimize processes, enhance product development, and drive operational efficiency
My journey has been marked by a continuous quest for knowledge, an unrelenting passion for data-driven insights, and an unwavering commitment to guiding pharmaceutical companies towards success in an ever-changing world.
Nancy.Kapila@rootsanalysis.com
https://www.linkedin.com/in/nancy-kapila-4336b4129/
Sources
Source 1: https://investor.iconplc.com/news-releases/news-release-details/leo-pharma-and-icon-enter-strategic-partnership-propel-clinical
Source 2: https://www.iqvia.com/-/media/iqvia/pdfs/library/fact-sheets/iqvia-virtual-trials.pdf
Source 3: https://www.medpace.com/wp-content/uploads/2023/03/Article-Wearable-Biosensors-for-DCTs-and-HCTs.pdf
Souce 4: https://www.parexel.com/application/files/resources/assets/TopTenRulesFor-Success-in-DCTs_Article_r2.pdf
Source 5: https://investors.science37.com/static-files/0fc6f687-528d-43c5-a229-a6ba4f2a664c
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