Clinical Validation Services
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based in USA
Method comparison studies, interlaboratory reproducibility studies, enrollment studies, exploratory staining studies, digital pathology primary diagnosis , validations, new instrument ...
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Manufactured by ResMetrix Medical Ltdbased in ISRAEL
Resmetrix clinical results show high correlation between respiratory signals from Resmetrix’ strap and a spirometer/flow meter tidal volume signals. In asthmatic patients, the system detected successfully changes in respiratory patterns during mild attack and response to treatment. Studies in exercise, the system demonstrate the ...
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based in USA
Deliver effective treatments to your patients. Our clinically validated software programs are designed to deliver effective treatments to your patients while offering the favorable safety profile inherent to a digital ...
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by Biodesixbased in USA
Evidence-based clinical research; We are committed to continuously add to our growing body of clinical evidence by publishing and presenting new data and insights on the clinical validation and utility of our diagnostic ...
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by Natera, Inc.based in USA
Why partner with Signatera for your clinical trial? Clinically validated across multiple solid tumors, Signatera has shown to predict relapse in >98% of patients without further treatment. Experienced team with Global reach: CE Mark, three FDA Breakthrough Device Designations, 8 Non-Significant Risk (NSR) determinations. >60 Natera IP ...
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Manufactured by Resolution Medicalbased in USA
Class I, II, III products from idea/concept through commercialization. Solid Modeling and Prototyping. Extensive 3D Printing. Bench model development & testing. Pre-clinical study support. Engineering Feasibility Studies. Design and Development. Test Method Development & Validation. Design Verification Testing. Design Validation ...
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Manufactured by SEQENS Groupbased in FRANCE
Seqens provides GMP testing on Active Pharmaceutical Ingredients (API) and excipients. We have an extensive team focused on the development and clinical phase appropriate validation of sensitive and specific analytical methods. Our analysts work closely with our chemists to develop In Process Control, isolated intermediate, and finish ...
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Manufactured by Nexelisbased in USA
From Fit-for-Purpose Development to Qualified and Validated Clinical Assays. Nexelis, a Q² Solutions Company, is a leading partner in assay development and technology transfer, with scientific discipline, critical thinking, and agility. Fit-for-purpose assay development on a wide variety of platforms support your small molecule, ...
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based in USA
Building your own wearable and digital health solution is expensive and time-consuming. Biostrap Connect makes it affordable and ...
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Manufactured by Ulisse BioMedbased in ITALY
As a provider of excellent molecular diagnostic solutions, ULISSE BIOMED offers to customer the development of customized solution tailored to any need, working in any phase of the project. Because your success is our ...
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based in USA
Delivering a medical product to market can be a long and complicated process, even when you’re familiar with the regulatory requirements.But when requirements are rapidly changing or when you’re entering international markets, the process can seem ...
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based in AUSTRIA
The objective of the Hepatitis B virus (HBV) Program is to utilize the HOOKIPA Technologies to design arenavirus vectors (Lymphocytic Choriomeningitis Virus or Pichinde Virus based) suitable for treatment, cure or prevention of HBV. Together with our partner Gilead Sciences we intend to develop functional therapies for patients already infected with ...
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based in USA
5 year survival for breast cancer is 5x higher in the earliest stage of the ...
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Manufactured by Humworld Inc.based in USA
Integrating behavioral health care with primary care (“behavioral health integration” or “BHI”) is an effective strategy for improving outcomes for people with mental or behavioral health ...
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by ACMIT Gmbhbased in AUSTRIA
From the initial idea to the clinical application of a medical technology product, many development steps are to take and obstacles to overcome. ACMIT is your ISO-13485 certified partner during the complete innovation process and offers expertise, guidance and assistance in every single step. ...
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Manufactured by Veracytebased in FRANCE
Veracyte’s professional framework for clinical trial assay (CTA) and companion diagnostics (CDx) development allows our clients to confidently advance priority projects. With an end-to-end service infrastructure, we support all aspects of assay development, manufacturing, life cycle management, regulatory submissions, marketing ...
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based in CHINA
Burning Rock offers integrated companion diagnostic development services for biopharma partners to streamline the co-development and commercialization of targeted drugs and respective CDx (including registration testing, clinical evaluation and finally obtain registration certificates. Our US-based lab and R&D team ...
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Manufactured by Novela Neurotechbased in USA
The SPEAC® System is a portable system designed to monitor and analyze surface electromyography (EMG) signals that may be associated with generalized tonic-clonic (GTC) seizures and to provide an alarm to alert caregivers. The System provides adjunctive monitoring during periods of ...
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based in GERMANY
Implementing outcome measurement in routine clinical practice is an ongoing and interactive process. Since 2014, Heartbeat Medical has worked with leading healthcare organizations to make digital PRO collection part of their day-to-day operations. So far, together with our partners, we have made the monitoring of treatment outcomes a ...
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based in GERMANY
Biomarkers are important when it comes to the development of novel drugs and mechanisms and are also gaining importance as companion diagnostic ...
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