Founded in 1996, FCA Venture Partners has a long history of investing in successful healthcare entrepreneurs. The firm is passionate about building sustainable businesses and providing strategic value to their portfolio companies. FCA invests $3-6M in fast growing healthcare companies making processes in the industry faster, better, and cheaper while improving the quality of care and the patient experience. With its location in Nashville, roots with Clayton Associates and the McWhorter Family, and deep involvement in the growth of the U.S. healthcare community, FCA Venture Partners is poised to take advantage of disruptive opportunities that help move healthcare forward.

FCA Venture Partners

PJC is an early-stage venture capital firm focused on investing in, supporting, and building relationships with entrepreneurs who are creating the future. The firm has invested in over 100 companies across North America including notable companies like Expensify, Nest, BlockFi, GetWell Network and Nexamp. PJC was founded in 2001 and is based in Boston, Massachusetts.

GenHenn Capital is a single-family office that specializes in private equity and venture capital investments.

GenHenn Venture

Diligent Pharma

Diligent Pharma is a platform that streamlines the selection and qualification of clinical trial service providers. It simplifies and accelerates the process for identification, selection, and qualification of clinical trial service providers. Trial sponsors can access standardized Vendor Qualification Assessment (VQA) reports and Request for Information (RFI) information from Diligent. As a result, they will require significantly less time and money to qualify a GCP vendor before beginning a clinical investigation.

Pennsylvania-based Diligent Pharma provides software for selecting clinical trial vendors. The company additionally provides a centralized technology platform to assist with vendor qualification and clinical trial execution. Its vendor qualification process supports vendor-submitted responses to Requests for Information (RFI), as well as validating Vendor Qualification Assessment (VQA) reports based on independent assessments.

Incorporating technology to improve efficiency and success rate of clinical trials

Clinical Trial Technology

Pennsylvania-based Diligent Pharma provides software for selecting clinical trial vendors. The company additionally provides a centralized technology platform to assist with vendor qualification and clinical trial execution. Its vendor qualification process supports vendor-submitted responses to Requests for Information (RFI), as well as validating Vendor Qualification Assessment (VQA) reports based on independent assessments.The company works with both clinical trial sponsors and service providers to provide its platform on a subscription basis, which it claims can expedite the process of ensuring compliance, risk-based vendor selection, and onboarding of vendors. Funding and financialsIn May 2023, Diligent Pharma raised USD 8.3 million in a Series A funding round led by FCA Venture Partners, along with participation from other venture capital firms and private investors. The raised funds were set aside to scale the company’s data offerings, along with its content strategy.

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’s solutions are targeted at industries like biotech and pharma, diagnostics, and clinical research organizations. Its solutions are built in line with industry-standard compliance and data protection standards including HIPAA, GDPR, and ISO 27001.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.Key customers and partnershipsAs of June 2024, the company had supported 14,000+ studies and 6 million patients through clinical trials across 90+ countries, since launching in 2007. In terms of therapeutic areas, Castor had supported a range of different areas, including oncology, cardiovascular diseases, and diabetes. The company had been engaged by 500+ organizations, including the World Health Organization, Click Therapeutics, and Stryker. 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. In February 2024, the company partnered with Microsoft to use Microsoft Azure to bring modern AI to clinical trials. The feature was released to help Castor users develop their studies faster by simplifying complex tasks in the study build process. The company additionally noted that it was planning to release its first in a line of Practical AI features to all its users in public Beta. Funding and financialsThe 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.

Castor

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 partnershipsAs of June 2024, Florence supported over 18,000 research sites, across 55+ countries, with key customers including Pfizer. The usage of the company’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 financialsThe 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.

Florence Healthcare

Huma is a UK- and US-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 </a>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.In July 2024, the company was <a href="https://sp-edge.com/updates/31552">estimated to be valued at nearly USD 1 billion</a> when it secured a Series D investment of USD 80 million. Key customers and partnershipsSome of the key partners working with Huma include AstraZeneca, Johnson &amp; Johnson, Bayer, Stanford University, and the University of Cambridge. As of July 2024, the platform supported 3,000+ hospitals and clinics, screened over 35 million individuals, and had 1.8 million active users across 70 countries. Huma was awarded the 2021 Prix Galien Award, which is widely considered the “Nobel Prize” for pharmaceuticals and life sciences.The company announced a partnership with Xyla Elective Care in June 2022, to provide support to the UK’s National Health Service in delivering and managing virtual wards.

Huma

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.In August 2024, Medable launched 'Medable Studio', an all-in-one application for configuring, translating, validating, and launching electronic clinical outcome assessment (eCOA) Plus solutions (which include eCOA, e-consent, televisits, and sensors) into clinical trials. The no-code suite aimed to simplify the complex eCOA launch process, offering biopharmaceutical companies greater control and transparency. Medable Studio includesda point-and-click builder for creating assessments and instruments, a visual schedule of assessments builder, a translation workbench, and a content library. The platform enabled users to rapidly build and launch complex clinical trials, with the ability to create protocol-fit study designs in hours instead of months.As of June 2024, the company offered its platforms across 60 countries and was accessible by over 120 companies. The company’s platform is compliant with industry standards, including HIPAA, FDA’s 21 CFR Part 11, and GDPR.Key customers and partnershipsAs of June 2024, Medable claimed to work with 14 out of the top 20 pharmaceutical companies, in addition to working with a range of partners, including Cognizant, Accenture, Oracle, and PwC.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’s customers.In September 2022, the company announced a four year agreement with GlaxoSmithKline to use Medable’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’ 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.In May 2024, Medable partnered with Masimo, a medical technology provider, to incorporate new wearable devices in clinical research. Medable announced it would include the MightySat Rx pulse oximeter by Masimo in its platform for various major clinical trials, particularly in lung and breast cancer research.

Medable

Headquartered in New York, 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.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.In April 2024, the ObvioHealth launched ObvioGo 2.0, an enhanced platform and mobile application designed to meet the unique needs of trial sites and sponsors. The upgraded platform allows the combination of hybrid and virtual trial designs within one study. It includes features such as the ability to create site-specific workflows, integration with other clinical systems, and a streamlined translation process. Additional features include a built-in virtual assistance team, COACH, for trial tasks support and a patient identifier tool for patient registration and data correlation.As of June 2024, the platform catered 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. Key customers and partnershipsAs of June 2024, Obvio Health’s client base included companies like GlaxoSmithKline, Pfizer, Bayer, Danone, and General Mills. As of June 2024, the company’s operations were spread over 28 countries and had supported obtaining consent from 40,000+ patients across 40 clinical trials since its launch.In March 2022, Obvio partnered with Renovia to conduct the first fully virtual trial in urogynaecology, based on Renovia’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 financialsThe 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’s preferred virtual clinical trial provider.

Obvio Health

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.

Companies using remote patient monitoring tools and other connectivity solutions to enable remote collection of patient data and monitoring and run trials virtually, without requiring the patient to be physically present in the clinical trial site.

Companies that offer workflow management platforms that are used to manage logistics tasks and processes for clinical trials, primarily the randomization of assigning patients in a clinical trial and automation of logistics workflows based on clinical trial data.

This is the use of software, incorporating AI and Machine Learning technology to improve the matching process of patients with suitable clinical trials.

Companies that offer software solutions for identifying and evaluating potential trial sites, along with documentation and workflow management systems to complete the processes before launching, including electronic patient consent and other required regulatory tasks.

Includes companies that provide digital data management platforms to collect and store patient reported outcome data. These platforms are also incorporating data analytics to help understand the results and identify trends and patterns. Additionally, the platforms are enabling connectivity with remote monitoring devices, including Medical Internet of Things.

Companies that provide software tools that help with the design of clinical trials, including identifying protocol violations, collecting participant input on potential design ideas for the trial, and crowdsourcing of protocol ideas for clinical trials.

Most CTT platforms are offered on a B2B basis to companies carrying out clinical trials

Startups in this hub use IoT to support report patient monitoring and data gathering

Offers digital platforms that accelerate clinical trials and evaluations

AI/ML algorithms can be used to automate the analysis of patient data

Startups in this hub seek to improve clinical trial diversity by including underrepresented communities

Diligent Pharma

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