List of Clinical Research Companies with Phase 2 Active Clinical Trial - 26
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AMT Medical Zonneoordlaan 17, Ede, Gelderland 6718, NL | AMT Medical is a clinical-stage medical device company based in Ede, Netherlands, with additional facilities in Utrecht. Founded in 2015, the company specializes in developing innovative solutions for cardiac and neurosurgical bypass procedures. Their focus is on transforming bypass surgery through minimally invasive techniques, which include off-pump heart bypass surgery that avoids stopping the heart or fully opening the chest. The company offers a Cardiac Bypass System designed for keyhole and robotic surgery, which has successfully completed First-in-Human trials and is currently undergoing CE certification in Europe. Additionally, AMT Medical has commercialized a Neurosurgical Bypass Device, recognized as a Class III medical device in the EU and U.S., and noted for its life-saving capabilities. With multiple patents protecting their technology, AMT Medical aims to set a new standard in the $15 billion coronary artery disease market, targeting cardiac and neurosurgeons with their advanced solutions. |
BioCytics Huntersville, North Carolina | BioCytics via the Human Applications Lab is focused on bringing personalized oncology treatments to the market. BioCytics has an ongoing IRB-approved clinical trial (BioCytics 0001; NCT00571389) that allows for the collection and study of blood and tissue samples from consenting cancer patients. We are incubated within Carolina BioOncology - a preferred cancer treatment and Phase I drug testing facility. BioCytics was founded by Dr. John Powderly, MD, medical board certified oncologist and a certified physician investigator (CPI), who is also president of Carolina BioOncology Institute (CBOI). |
bioRASI Aventura, Florida, United States | For over 20 years, Biorasi has been to go-to CRO (Contract Research Organization) for small to midsized biopharma companies, optimizing speed-to-market solutions across global clinical trials in oncology, neurology, dermatology, and cell and gene therapy. Our #OneTeam of leaders and clinical study experts focus on the qualities necessary to succeed in today's clinical trial industry – flexibility, reliability, and transparency. It is Biorasi's mission to be a catalyst for growth, innovation, and evolution in the field of clinical research – moving the industry forward while improving results for our partners and outcomes for their patients. Our culture is based on our strong commitment to building true partnerships with our sponsors. We approach all of our trials with urgency, commitment, and resolve. Biorasi is able to directly support studies in the Americas, Europe, and APAC. We have received multiple accolades including placement in the INC 500 and 5000 list of fastest-growing companies in America, Frost and Sullivan's Entrepreneurial Company of the Year for the CRO Industry, and the CRO Leadership Award from Life Science Leader magazine. |
Charles River Wilmington, Massachusetts, United States | At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guides us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. |
Citeline New York, US | Citeline powers a full suite of complementary business intelligence offerings to meet the evolving needs of health care professionals to accelerate the connection of treatments to patients and patients to treatments. These patient-focused solutions and services deliver and analyze data used to drive clinical, commercial and regulatory-related decisions and create real-world opportunities for growth. Our global teams of analysts, journalists and consultants keep their fingers on the pulse of the pharmaceutical, biomedical and medtech industries, covering it all with expert insights: key diseases, clinical trials, drug R&D and approvals, market forecasts and more. |
Conceivable Life Sciences New York, New York, United States | Conceivable has developed the world’s first fully automated IVF lab. Our end-to-end reinvention of today’s largely manual, artisanal labs delivers new levels of precision, quality, and scalability. Simultaneously, Conceivable brings the innovation of modern cell therapies to IVF. We are already exceeding the clinical benchmarks of today’s best IVF labs. Worldwide 95% of the infertile population–and 80% in the United States–don’t have access to IVF. Conceivable exists to change this. By automating the IVF lab we will vastly broaden the availability of this Nobel Prize winning therapy, improve results, and meet the demands of millions of infertile people wishing to achieve the dream of becoming parents. |
CSSi LifeSciences Glen Burnie, Maryland, United States | CSSi LifeSciences™ Drug & Medical Device Commercialization & Medical Device CRO Our goal is to ensure a successful and expeditious pathway to commercialization for our clients’ drugs and medical devices by providing insight-driven analysis that saves time, development costs, and resources. We enable faster, more informed decision making to increase commercial success, while reducing the risk of late-stage failures and post-authorization action. Unparalleled Success from Discovery to Commercialization • Commercialized over 500 new drugs, biologics, medical devices, and in-vitro diagnostics • Over 250 medical device 510(k) Class 1-3 submissions with 100% success. • Extensive Orphan, “First in Class,” and “First In” Indication success. • Reduced time to approval by over 600 days. • Over 100 NDA, ANDA and BLA submissions, with 96% success. • Greater than 60 EMA CHMP Marketing Authorizations. • SmartStudyTM design and feasibility assessments enhanced study efficiency and success and reduced protocol amendments by over 50%. CSSi LifeSciences Medical Device CRO has experience navigating regulations in over 100 countries. Often companies struggle with the pathways for a medical device from design to commercialization because of the ambiguity and complexity of the process. Regulations and requirements change frequently and vary by notifying bodies, country, level of risk (i.e., Class 1-3), specific product claims, and intended use. Our diverse team has many years of medical device commercialization experience, with the knowledge that goes beyond published guidance, documents and initiatives. CSSi LifeSciences Medical Device CRO aims to impact the timeline of regulatory clearance and increase profitability. |
DevPro Biopharma Miami, Florida, United States | DevPro Biopharma is a Clinical Research and Development Accelerator with the mission to design, develop, and deliver molecules into medicine. |
Elephas Madison, Wisconsin | Elephas is a biopharmaceutical company focused on developing an oncology imaging diagnostics platform to predict response to immunotherapy using the latest advances in metabolic and ex-vivo technology. The company is also building an instrument platform that will inform how clinicians treat cancer patients by interrogating live human tumors ex vivo. |
Enspire DBS Therapy, Inc. 9500 euclid avenue, cleveland, ohio, united states | Enspire DBS Therapy, in partnership with Cleveland Clinic and Boston Scientific, is developing a proprietary deep brain stimulation (DBS) therapy to restore motor function for stroke survivors living with disability. Enspire is currently sponsoring EDEN, a Phase I clinical trial of DBS therapy for stroke recovery. |
Erbe Group 17 waldhoernlestrasse, tuebingen, baden-wuerttemberg, germany | As a family-owned and operated business, Erbe develops, manufactures,and markets systems for professional use in various medical disciplines all over the world. Since the company's foundation, Erbe has continuously reshaped and adapted its business to an ever-changing reality in several key disciplines such as gastroenterology, general surgery, gynecology, pulmonology and urology. The portfolio comprises devices and instruments for electrosurgery, vessel sealing, plasma surgery, cryosurgery, hydrosurgery, and imaging. Over the last ten years, sales have increased by 75% with an 85% increase in employees to over 1.800 colleagues worldwide. Today, the international group of companies is represented in 110 countries around the world with sales and service units, sales and production units and an international distributor network. A dedicated team of around 260 employees works intensively in research and development. Close cooperation with renowned physicians from medical faculties and hospitals is a key success factor that helps Erbe to successfully drive medical development forward Imprint: https://de.erbe-med.com/de-en/meta-navigation/imprint/ Disclaimer: https://erbe-med.com/fileadmin/pdf/company/Terms_of_use_EN.pdf |
Fulgent Genetics 4399 Santa Anita Ave, El Monte, California 91731, US | Our mission is to develop flexible and affordable diagnostics and therapeutics that improve the everyday lives of those around us. Founded in 2011, Fulgent has evolved into a premier, full-service genomic testing company built around a foundational technology platform. Through our diverse testing menu, Fulgent is focused on transforming patient care in oncology, anatomic pathology, infectious and rare diseases, and reproductive health. We believe that by providing a wide range of effective, flexible testing options in conjunction with best-in-class service and support, we can redefine the way medicine is managed for patients and clinicians alike. - Our Products & Services - Fulgent Genetics https://www.fulgentgenetics.com/ Fulgent Oncology https://fulgentoncology.com/ Fulgent BioPharma https://biopharma.fulgent.com/ Picture Genetics https://picturegenetics.com/ HelioLiver https://www.helioliver.com/ Fulgent is a CLIA-certified and CAP-accredited laboratory. _____________ NASDAQ: FLGT |
HitGen Chengdu, Sichuan, China | HitGen Inc. (SSE: 688222.SH), founded in 2012, is headquartered in Chengdu, China, with subsidiaries in Cambridge, UK and Houston, USA. HitGen is committed to building a world-class innovative biopharmaceutical enterprise and contributing to the better life and health of mankind. Engaged in the discovery and optimization of small molecules and nucleic acid drugs, HitGen dedicates itself to cultivating an internationally leading drug discovery and optimization system centered on four key technology platforms, including DNA-encoded library technology (including DEL design, synthesis and screening, and application expansion), fragment-based drug discovery and structure-based drug design technologies (FBDD/SBDD), synthetic therapeutic oligonucleotide technology (STO), and targeted protein degradation technology (TPD). It provides new molecular entities (NMEs) at different stages of research and development for the pharmaceutical industry, through its diversified business models including research and development services, out-licensing of projects at different R&D stages, and new drug launches in the long term, with an aim to address unmet clinical needs with innovative therapeutic solutions. As a leader in the field of DEL technology, HitGen has been committed to the development, application and improvement of DEL technology since its establishment. HitGen has approximately 20 in-house drug discovery projects at different stages of research and development, among which 4 have obtained IND approvals and entered into clinical trials. HitGen is in collaboration with pharmaceutical, biotech and chemical companies, foundations and research institutes in the Americas, Asia, Europe, Africa, and Oceania. For more information, please call +86-28-85197385, +1-508-840-9646 or visit www.hitgen.com. For business development: bd@hitgen.com |
Inocras Inc. 6330 Nancy Ridge Dr, Suite 106, San Diego, California 92121, US | Inocras is a company for whole genome sequencing, providing a comprehensive view of a patient's entire genetic profile through WGS analysis and interpretation. Focusing on cancer and rare diseases, we aspire to fundamentally change how the world treats genetically driven diseases with an unsurpassed WGS databank and an integrated platform for generating, collecting, and analyzing genomic data. |
KGK Science Toronto, Canada | Since 1997, KGK Science has played a key role in the natural health product industry by providing our clients with high-quality clinical research and regulatory expertise to bring safe and effective products to global markets. As a full-service premium contract research organization (CRO) supporting the nutraceutical, cannabis and hemp industries, KGK is one of the most reliable resources for brands looking for an experienced, trustworthy team of scientific researchers, consultants, and regulatory specialists to develop customized claim substantiation and path-to-market strategies. From clinical study design to impactful product marketing, KGK has client success down to a science. At our state-of-the-art clinical research facilities, clinical staff, researchers, and regulatory experts quickly turn requests into results. We've guided hundreds of companies in taking their initial product concepts on to clinically proven claims and beyond, working to differentiate ideas and offer unique pathways through complex regulatory bodies including Health Canada, FDA, and FTC. Recognized globally as thought-leaders in cannabinoid science and regulation for the natural health product industry, KGK Science is proudly the first CRO in Canada to possess a Cannabis Research License, extending our 22 years of industry experience to include cannabis and hemp-derived products. As the leading CRO in the cannabis industry, KGK is focused on expertly conducting clinical trials and providing regulatory support to help bring innovative new health products to market, continuing to further global research and unlock the true value of the cannabis industry for clients and consumers. |
Lindus Health New York, New York, United States | Lindus Health is an anti-CRO running radically faster, more reliable clinical trials for life science pioneers – bringing ground-breaking treatments to patients more quickly. This is achieved through a commercial model that aligns incentives (fixed-priced quotes per study, with milestone-based payments), a world-class clinical operations team with its unique software platform, and access to over 40 million Electronic Health Records. Clinical trials are the biggest bottleneck to advances in healthcare. Lindus Health removes this constraint through end-to-end execution of clinical studies driven by technology and forward-thinking approaches to clinical operations.To date, Lindus Health has delivered clinical trials across the US, UK and Europe to tackle a range of conditions, including diabetes, asthma, acne, social anxiety, major depressive disorder, hypertension, chronic fatigue syndrome and insomnia. The company has raised over $80M from investors including Peter Thiel, Balderton, Creandum, Firstminute Capital, and Seedcamp. |
Massive Bio New York, New York, United States | Massive Bio collects and curates the latest scientific knowledge in genomics of cancer, connects with clinical information incorporate all new discoveries in treatment plans. |
Med Institute (Cook Biotech) West Lafayette, Indiana, United States | MED Institute accelerate product development. MED Institute is dedicated to bringing new medical device products to market that are safe and effective for patients. From concept to commercialization, our team has the knowledge and experience to guide your products through the complex steps required for market approval. |
Mendel San Jose, California, United States | Mendel AI is the only clinical AI platform that performs clinical reasoning to supercharge clinical data workflows. Powered by coupling large language models with a clinical Hypergraph, Mendel's AI copilots, known as Hypercubes, offer clinically trustworthy and explainable insights, streamlining tasks like cohort building, chart review, and data discovery. Mendel's solutions cater to biopharma, providers, and diagnostics, integrating seamlessly with existing tools and delivering proven results We strive for excellency, to be authentic and original, and to make a difference by greeting our challenges head on. Please visit our website, mendel.ai, to learn more about our company, goals, and values. |
Novotech Sydney, Australia | Founded in 1997, Novotech is a global full-service clinical Contract Research Organization (CRO) focused on partnering with biotech companies to accelerate the development of advanced and novel therapeutics at every phase. Recognized for its industry-leading contributions, Novotech has received numerous prestigious awards, including the CRO Leadership Award 2023, the Asia Pacific Cell & Gene Therapy Clinical Trials Excellence 2023, the Asia-Pacific Contract Research Organization Company of the Year Award since 2006. The Company offers a comprehensive suite of services including laboratories, Phase I facilities, drug development consulting, regulatory expertise, and has experience with over 5,000 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. With a presence in 34 office locations and a dedicated team of 3,000+ professionals worldwide, Novotech is a trusted end-to-end strategic partner of choice. For more information or to speak to an expert team member visit www.Novotech-CRO.com |
N-Power Medicine 2221 Broadway St, Redwood City, California 94063, US | N-Power and its purpose-built clinical research platform empowers oncology practices and biopharma companies to accelerate drug development and make better-informed decisions. N-Power catalyzes clinical research by equipping oncology practices with the N-Power Platform and connecting them to industry research sponsors. The N-Power Platform consists of: - The real-time Kaleido™ Registry, conducted with patient consent, that defines standardized data collection at the point of care and is malleable to partner needs, - A technology solution that enables data collection and analysis, and - Embedded on-site and virtual staff who support delivery of routine care, implement standardized, registry protocol-defined data collection and augment site staff in clinical research. By partnering with oncologists, research staff and patients in unlocking the full potential of every patient's data, we are expanding access to clinical trials and enabling unprecedented insights for biopharmaceutical drug development. |
Optimapharm Almeria Business Tower, 10th Floor, Ulica grada Vukovara 284, Zagreb, 10000, HR | Optimapharm is a globally operating, leading, mid-sized, full-service CRO aiming to deliver new therapies to improve and save patients' lives. Optimapharm's key priorities are our people and consistently exceeding our client's expectations. With 26 strategically located offices across Europe, Optimapharm gives unrivalled access to Patients and Investigators worldwide. In-depth expertise and long-standing experience, combined with a flexible and collaborative approach, allow optimization of design and planning; through its strong track record of delivery excellence and committed and stable project teams, Optimapharm has secured a high level of repeat business over the years. Companies Figures • 510+ staff members • Excellence in delivery and superior project performance with an investigator network of 1000+ active sites • Close client relationship & high client retention rate of 85% • Highly educated workforce & low staff turnover rate; less than 15%, across the organization • Regional Cost-effective solutions ==== Full-service study delivery, Stand-alone service and Functional Service Provider are the 3 pillars Optimapharm offers to best respond to planned clinical development and efficiently resource clinical projects. • Regulatory Affairs • Medical Affairs • Medical Writing • Clinical Monitoring • Project Management • Data Management • Biostatistics • Safety and Vigilance • Quality • Translation Services OPTIMAPHARM's offices: - Austria - Belgium - Bosnia and Herzegovina - Bulgaria - Croatia - Czech Republic - Estonia - Finland - France - Georgia - Germany - Greece - Hungary - Lithuania - Republic of North Macedonia - Moldova - Poland - Romania - Serbia - Slovenia - Spain - Sweden - Switzerland - The United Kingdom - The United States of America |
P95 Rue Edith Cavell 66/3, 66, Uccle, 1180, BE | 4Clinics is a Contract Research Organization (CRO) providing Data management, Biostatistics, Scientific Writing, Regulatory Affairs and Clinical Operations services for clinical and epidemiological studies with a particular expertise in vaccines, immunology, immuno-oncology and medical devices. 4Clinics serves pharmaceutical, biotechnology and medical devices companies as well as NGOs, hospitals and researchers with tailor-made services including remote biometry and medical writing platforms. 4Clinics has offices in Belgium, France and Morocco and has a global coverage. For more information, please visit www.4Clinics.com |
Pace® Analytical Services 1800 Elm Street, Minneapolis, MN 55414, US | Pace® Science and Technology Company makes the world a safer, healthier place. We partner with clients to provide the service, science, and laboratory data needed to make critical decisions that benefit us all. Through a nationwide laboratory network, Pace® advances the science of businesses, industries, consulting firms, government agencies, and others. ANALYTICAL SERVICES Pace® Analytical Services is a division of Pace® Science and Technology, providing local testing and analytical services backed by a large, national laboratory and service center network. Through in-lab, mobile, and emergency onsite containment and regulatory services, we ensure our air, water, soil, and more are safe for our communities and lives. LIFE SCIENCES Pace® Life Sciences is a division of Pace® Science and Technology committed to advancing the science of the pharmaceutical and biopharmaceutical industry by providing full-service CDMO/CRO capabilities and professional services for in-house labs through a nationwide network of service centers, manufacturing sites, and FDA-registered laboratories. COMMITMENT We believe the work our customers do is important to improving our communities and lives and are committed to supporting them through strong partnerships, delivering upon expectations, and providing exceptional customer service. |
Science 37 Los Angeles, California, United States | Science 37's mission is to accelerate clinical research by enabling universal trial access for patients. Through our solutions; the Metasite™ and Patient Recruitment, we accelerate enrollment by expanding the reach of clinical trials to patients beyond the traditional site and rigorously qualifying patients prior to referring them to a traditional site. Our solutions are powered by a proprietary technology stack with in-house medical and operational experts that enhance quality through standardized workflows and best-in-class study orchestration. |
SPINAL STABILIZATION TECHNOLOGIES, LTD Kilkenny City | Spinal Stabilization Technologies, LTD ("SST") is a commercial-ready U.S. medical device company with a manufacturing facility in Ireland through its Irish subsidiary. The Company has developed a new surgical device and procedure for restoring the nucleus pulposus of the lumbar spine. The company has extensive worldwide intellectual property. The products and techniques SST develops are based on the philosophy that less invasive surgery may be associated with better clinical outcomes. These products and techniques could improve the lives of many patients that have limited options for treating their back pain. The company is focused on evidence-based medicine, has completed three trials, is currently conducting a clinical trial and is in the planning phase of two additional clinical trials. |