Clinical Regulations Services
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by HingeClinicabased in USA
Our clinical operations teams have extensive experience in conduct of multicentric global clinical trials in various therapeutic areas. Our team consists of experienced Clinical Managers, CRAs, Medics, Pharmacologists with excellent medical background and in-depth knowledge on clinical trial regulations and ICH ...
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by Phortas GmbHbased in GERMANY
Our Medical Writers can help you develop all documents needed to support your product in a development phase: Investigators Brochure (IB), Investigational Medicinal Product Dossier (IMPD), Development Safety Update Report (DSUR), Clinical Study Protocols and Reports, Pediatric Plans, Briefing Documents for any Authority meeting, ...
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Manufactured by Avaniabased in AUSTRALIA
In tandem with preclinical strategy development, partner with us for a clinical program strategy that will move your product ...
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based in RUSSIA
Development of a full document set for trial; Clinical study design. Clinical study protocol. Informed consent. Investigator’s Brochure. Clinical study reports. Articles and publications. Translation of ...
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based in USA
With an unwavering commitment to delivering high-quality care, we deploy stringent virtual care protocols and clinical quality-assurance ...
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based in USA
The xVantage Group helps customers with their medical device submissions, their clinical trial protocols and submissions, managing data collaboration from CROs, their regulated production diagnostics, and other regulated processes that occur on the DNAnexus ...
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Manufactured by Bracco Spabased in ITALY
The Company focuses on researching, developing, manufacturing and marketing of contrast agents, medical devices and solutions for improving Diagnostic Imaging efficiency, patient safety and cost effectiveness. ...
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Manufactured by Mevion Medical Systemsbased in USA
Mevion’s commitment to its customers does not stop at implementation. Mevion looks forward to forming a long-term collaboration to further develop proton therapy as part of a comprehensive customer care ...
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Manufactured by GenomeMe Lab Inc.based in CANADA
Immunotherapy is emerging as the treatment of choice for cancer and has been used to successfully cure many cancers already. However, immunotherapy requires precision diagnostics using IHC-based biomarker detection, with most clinical protocols allowing for the detection of only one biomarker at a ...
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by Envigobased in UNITED KINGDOM
A Phase I study is a safety trial in a small number of healthy human volunteers or patients. It is typically the first human exposure to a New Chemical Entity (NCE) and takes place in a controlled clinical setting. To be granted permission by the regulatory bodies to perform such a study, a comprehensive package of toxicology data, ...
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Manufactured by Ariana Pharmabased in FRANCE
Using our pioneering eXplainable AI platform KEM® we design and execute Precision Medicine clinical trials, with an unparalleled successful track record across multiple therapeutic areas. Thanks to our XAI KEM® platform we integrate extensive pre-clinical, clinical as well as Real World Evidence data, to define best dose, identify ...
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by OracleBiobased in UNITED KINGDOM
Good Clinical Practice (GCP) is an internationally recognised ethical and scientific standard for designing, recording and reporting trials that involve the participation of human subjects. Studies conducted in accordance with this standard provides assurance that the rights, safety and wellbeing of trial subjects are protected and that ...
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Manufactured by Avaniabased in AUSTRALIA
Avania clinical safety management specializes in the distillation and dissemination of the information you need to design an efficient program and bring your product to ...
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by Noblis, Inc.based in USA
facilitates paperwork and workflow. Noblis’ staff has extensive experiences in IT management, software development and implementation, electronic medical and patient records, technology integration, direct patient clinical and diagnostic care, business-case analysis, product recall and alerts, and evaluation of disease trends. Noblis has ...
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based in USA
A Focus on Transforming Disease Management. Our approach to product development starts by identifying areas of unmet medical need where precision medicine could significantly improve disease staging and/or patient care decisions. We focus first on confirming the clinical challenges of these unmet needs and look for opportunities where ...
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based in BELGIUM
Biostatistics Services is IDDI’s DNA and Core CompetenceAdvanced Statistical Methodology and Operational Excellence for Leaner and Faster Clinical Trials. Biostatistics is at the heart of every clinical study, driving study design, protocol development, clinical data collection, data analysis, and reporting. IDDI delivers optimal ...
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based in SWITZERLAND
Clinical trials are critical for determining the safety and efficacy of new medicines and the clinical value of diagnostic tests. They also provide critical information on the cost-effectiveness of a treatment or diagnostic test and how a treatment improves quality of life. This information is shared with regulatory authorities and payers in ...
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by Almac Groupbased in UNITED KINGDOM
the intended pharmacologic effect and be used to guide appropriate clinical dose-response studies as part of the agreed overall clinical trial ...
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by HingeClinicabased in USA
Our Medical and scientific Writing team is an integral part of clinical research. Our Medical Writers closely associate with biostatistics, medical affairs, safety and data management teams to deliver accurate, timely, and cost effective deliverables to the highest quality and scientific standards. We have a wide breadth of experience drawn ...
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by elminda Ltd.based in ISRAEL
CNS drugs exhibit the lowest approval success rates due to multiple challenges such as lack of efficacy in early and advanced stages of development, Poor target selection / engagement, poor translation from pre-clinical models and disease heterogeneity. BNA may contribute in CNS research and drug development by adding new objective ...
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