SimpleCTMS

SimpleCTMS is a Clinical Trial Management System (CTMS) for Sponsors & CROs. They are an eClinical software company founded in 2008 and headquartered in Oakland, CA, with a focus on clinical trial management systems that improve planning, execution and tracking of clinical trials. With many years of experience on the front lines of clinical trial management, they have a passion for innovating web-based applications to improve planning, execution and tracking of clinical trials.

<div>SimpleTrials provides a clinical trial management system through a monthly subscription business model dependent on the number of users and research sites. The basic package for clinical sites starts at USD 399 per month and scales up based on the level of customer and user support required.</div>

Incorporating technology to improve efficiency and success rate of clinical trials

Clinical Trial Technology

SimpleTrials

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 SimpleTrials provides a clinical trial management system through a monthly subscription business model dependent on the number of users and research sites. The basic package for clinical sites starts at USD 399 per month and scales up based on the level of customer and user support required.
 
 
 The platform includes multiple modules, including 1) contact management, 2) document management and electronic trial master file, 3) project planning contract and payment management, 4) subject tracking, and 5) reporting and business analytics. Additionally, SimpleTrials&rsquo; platform can be integrated with any third-party electronic data capture platforms selected by the research team. The platform is compliant with 21 CFR Part 11 and ISO 27001.
 
 
 Key customers and partnerships
 
 
 As of May 2022, its platform was used by over 80 CROs/research sponsors across 40 different countries. Some of the company&rsquo;s customers include Pulse Biosciences, InGeneron, Sarepta Therapeutics, and Prana Biotechnology.
 
 
 As of May 2022, the platform had been used in over 400 studies, with a combined total of over 15,000 clinical research sites using SimpleTrials to manage their clinical trials.
 
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 Headquartered in Amsterdam, Castor is a cloud-based e-clinical data platform that can be used for a range of tasks and processes during a clinical trial. It offers four solutions: 1) electronic data capture (EDC) to capture and process data from multiple sources including researchers, 2) electronic patient-reported outcomes (ePRO) to collect and manage patient-reported data on a centralized platform, 3) e-consent - to enable patients to be recruited, screened, and enrolled remotely, and 4) a decentralized clinical trials (DCT) platform to assist operators with managing DCT technologies and devices through a central platform. The company&rsquo;s solutions are targeted at industries like biotech and pharma, diagnostics, and clinical research organizations.&nbsp;
 
 
 Castor aimed to collect enough clinical trial research data to enable the reuse of data for AI-driven clinical trials, which would lower the costs of operating clinical trials and reduce the time taken to bring new drugs to market.&nbsp;
 
 
 Key customers and partnerships
 
 
 As of May 2022, the company supported over 8,500 studies and clinical trials across more than 90 countries since launching in 2007. In terms of therapeutic areas, Castor has supported a range of different areas including oncology, cardiovascular diseases, and diabetes. The company has been engaged by over 300 organizations, including the World Health Organization, Click Therapeutics, and Stryker. Castor&rsquo;s solutions are built in line with industry-standard compliance and data protection standards including HIPAA, GDPR, and ISO 27001.
 
 
 It was the first to incorporate machine learning into its system for the identification of Covid-19 patients. The company offered free access to its system for Covid-19 research projects, with over 200 projects using the platform as of June 2022.&nbsp;
 
 
 Funding and financials
 
 
 The company raised USD 45 million in Series B funding in July 2021, led by Eight Roads Ventures and F-Prime Capital. The funds were earmarked for product development, interoperability with partner systems, and market research on decentralized trials. The company had a headcount of 150 at the time of the Series B and was planning to expand to 200 by the end of 2021.
 
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Castor

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 Florence Healthcare offers a platform for clinical trial management. It has four key components: 1) SiteLink to start-up and monitor remote clinical sites, 2) eBinders to digitize and store research binders, 3) eConsent to simplify and digitize the consent process, and 4) Electronic Trial Master File to digitize the storage and transfer of files between sites and research sponsors. The platform is compliant with standard industry requirements including HIPAA, 21 C.F.R Part 11, ICF/GCP, and GDPR.
 
 
 Key customers and partnerships
 
 
 As of May 2022, Florence supported over 10,000 research sites across 45 countries, with key customers including Pfizer. The usage of the company&rsquo;s software tripled in 2020, driven by an industry shift toward digitalization as a result of the Covid-19 pandemic. In February 2022, the company was ranked as the best clinical trial platform out of a group of 190 for ease of setup, ease of use, and customer support.
 
 
 Florence partnered with Greenphire, a company focusing on patient convenience and financial management for clinical trials, in Janauary 2024. Through the partnership, Florence's platform will be integrated with Greenphire's to improve payment systems within clinical trials. Benefits of the partnership included reduced manual work for sites, faster payments, and better visibility of site activity for sponsors and Contract Research Organizations (CROs).
 
 
 
 
 Funding and financials
 
 
 The company raised USD 80 million in Series C funding in May 2021 led by Insight Partners. The proceeds were to be used to scale up its sales and marketing teams and improve the value proposition of the platform by reducing the time required by customers to implement and manage clinical trials.
 
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Florence Healthcare

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 Huma is a UK-based clinical trial tech startup that provides a digital platform to manage clinical trials, including decentralized clinical trials. The platform can be used throughout the clinical trial process, including patient recruitment, screening, electronic consent, clinical outcome assessments, patient-reported outcomes, and telemedicine. The platform is built up to industry standards in data privacy and security, including ISO 27001, 21 C.F.R. Part 11, and TxP.
 
 
 In June 2023, the company 
 <a href="https://sp-edge.com/updates/19352">
 received FDA 510(k) Class II FDA clearance
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 for its configurable disease-agnostic platform, including its cardiovascular risk score algorithm. The company received this FDA clearance in partnership with Health Canada and it allows Huma's platform to be used to monitor patients of all ages with any condition, including pediatrics and pregnancy. The Class II clearance also enables the platform to host algorithms that provide automated AI-driven data analytics for diagnosis, screening, clinical decision-making, predictions on health outcomes, and recommendations on dosage.
 
 
 Key customers and partnerships
 
 
 Some of the key partners working with Huma include AstraZeneca, Johnson &amp; Johnson, Bayer, Stanford University, and the University of Cambridge. As of May 2022, the platform supported more than 3,000 hospitals and clinics with more than 1.8 million active users on the platform. Huma was awarded the 2022 Prix Galien Award, which is widely considered the &ldquo;Nobel Prize&rdquo; for pharmaceuticals and life sciences.
 
 
 The company announced a partnership with Xyla Elective Care in June 2022, to provide support to the UK&rsquo;s National Health Service in delivering and managing virtual wards.
 
 
 Funding and financials
 
 
 Huma raised USD 33 million from AstraZeneca in March 2022 as a strategic investment. Additionally, as part of the agreement, the companies are to launch new products for software-as-a-medical-device (SaMD), including customized software development of SaMD companion apps for customers.
 
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Huma

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 Based in California and founded in 2015, Medable is a digital clinical trial management platform with a range of modules for different processes. These modules include a decentralized clinical trial platform to support decentralized trials using remote tools for data gathering, monitoring, televisits, and consent; digital patient screening to screen patients remotely and at scale; e-consent to enable patients to digitally consent for clinical trials; electronic clinical outcome assessments; and patient-reported outcomes to document data in real time and provide easy access for researchers. It also includes remote patient monitoring to make it easy for patients to record and share data with clinical research teams.
 
 
 Medable operates on a SaaS business model, with customers having the option of selecting and deploying only the modules required as part of their uniquely customized solution.
 
 
 As of September 2022, the company expanded to provide services to over 300 clinical trials based in more than 60 countries and in 26 languages. The company&rsquo;s platform is compliant with industry standards, including HIPAA, FDA&rsquo;s 21 CFR Part 11, and GDPR. 
 
 
 Key customers and partnerships
 
 
 As of May 2022, Medable works with a range of partners, including Cognizant, Accenture, Oracle, and PwC.&nbsp;
 
 
 In February 2022, the company announced a Medable Partner Network, which brought together a range of partners across different types. This included direct-to-patient, service, data, technology, and site partners. The objective of this partnership network is to speed up the innovation process and deployment of the platform at clinical sites, creating value for Medable&rsquo;s customers.
 
 
 In September 2022, the company announced a four year agreement with GlaxoSmithKline to use Medable&rsquo;s platform for clinical trials across multiple products. Financial terms of the agreement were not disclosed.
 
 
 In October 2023, the company partnered with Pluto Health, a healthcare coordination company, to enhance the clinical trial experience for participants and improve data collection during trials. Through the partnership, the companies aimed to connect patients to the right medical resources including access to clinical trials and home delivery of medication. Pluto Health's platform would collect participants&rsquo; health information and create personalized care plans, while Medable would offer features such as patient identification and remote patient monitoring. The partnership also aimed to improve data quality and facilitate long-term follow-up with patients post-trial.
 
 
 Funding and financials
 
 
 Medable raised USD 304 million in November 2021 at a USD 2.1 billion valuation co-led by Blackstone Growth and Tiger Global. The proceeds were to be used for the development of decentralized clinical trial technologies including telemedicine and remote monitoring as well as for the expansion of global operations.
 
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Medable

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 Headquartered in Singapore, Obvio Health provides a full service for clients, supporting them throughout the clinical trial process from the design and recruitment stages to outcome measurement and reporting. In addition to its technological platform, the company provides professional services to execute clinical trials using its in-house clinical operations team. The platform caters to 17 therapeutic areas, including cardiology, oncology, respiratory, men's and women's health, dermatology, gi, hepatology, mental health, oral health, and infectious disease (Covid-19). The platform is compliant with industry standards including 21 CFR Part 11, ICH-GDP, GDPR, and ISO 27001.&nbsp;
 
 
 According to the company, its platform was designed from the ground up to cater to digital trials run by virtual clinical teams, which resulted in faster patient recruitment (three months for Obvio compared to 12 months for physical site trials). In January 2022, the company launched an augmented electronic patient-reported outcome (augmented ePRO) module, which incorporates AI and manual scoring by experts/clinicians. The company claims this improves the accuracy and quality of data collected.
 
 
 Key customers and partnerships
 
 
 As of May 2022, Obvio Health&rsquo;s client base include GlaxoSmithKline, Pfizer, Bayer, Danone, and General Mills. The company has supported 42 clinical trials from launch to May 2022, spread over 28 countries.
 
 
 In March 2022, Obvio partnered with Renovia to conduct the first fully virtual trial in urogynaecology, based on Renovia&rsquo;s Leva device. The device helped patients with performing kegel exercises more effectively, in addition to monitoring compliance over the trial period.
 
 
 In November 2023, Obvio then partnered with Chemist Warehouse, the largest retail pharmacy chain in Australia, to improve the reach and efficiency of clinical trials. 
 Through the partnership, Chemist Warehouse agreed to promote ObvioHealth-managed trials to its customers in Australia, using both offline and online channels. Additionally, ObvioHealth agreed to utilize Chemist Warehouse's Telehealth services for studies that require clinician assessments. The collaboration aimed to increase the awareness and convenience of clinical trials, addressing two major hurdles in participant recruitment. The long-term goal of the partnership was to expedite the introduction of innovative therapies to the market more efficiently and economically.
 
 
 
 
 Funding and financials
 
 
 The company raised USD 31 million of Series B funding in June 2021 led by Dedalus Group and Novotech Health. The investment was primarily strategic, with Obvio benefiting from its Dedalus partnership in terms of European clinical trial compliance, while it became Novotech Health&rsquo;s preferred virtual clinical trial provider.&nbsp;
 
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ObvioHealth

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Companies offering data and workflow management platforms and solutions to assist with the operational management of a clinical trial, including site management, monitoring processes in terms of risk and documentation, and payment automation.

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