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Clinical Regulations Services In Usa
14 services found
by:Teladoc Health, Inc. based inPurchase, NEW YORK (USA)
With an unwavering commitment to delivering high-quality care, we deploy stringent virtual care protocols and clinical quality-assurance ...
Manufactured by:Atos Medical, part of Coloplast A/S based inMalmö, GERMANY
Atos Learning Institute is the learning and development platform of Atos Medical. The institute provides training and clinical tools for healthcare professionals working in the fields of laryngectomy and tracheostomy. The aim of Atos Learning Institute is to empower healthcare professionals through education and evidence-based practice to enhance standards of care and improve patient ...
by:DNAnexus, Inc. based inMountain View, CALIFORNIA (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 ...
Manufactured by:Regenity based inParamus, NEW JERSEY (USA)
Securing approvals can be challenging amid a shifting regulatory landscape. With a deep history in collagen-based products and polymer science, we support our clients through global regulatory submissions, claims development, as well as clinical study and protocol development consultations. With years of experience designing preclinical and clinical studies for regenerative devices, our team is ...
Manufactured by:Mevion Medical Systems based inLittleton, MASSACHUSETTS (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 ...
Manufactured by:Ariana Pharma based inParis, 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 patient selection and surrogate endpoint biomarkers as ...
by:Castle Biosciences, Inc. based inFriendswood, TEXAS (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 current staging or standards of care do not sufficiently ...
by:Noblis, Inc. based inFalls Church, VIRGINIA (USA)
Noblis effectively assists public-sector entities as they use enabling technology to solve many of the challenges that are commonplace in today’s healthcare environment. Appropriate use of IT can help improve the quality of care, reduce the costs of healthcare, prevent medical errors, and improve efficiencies as increased automation facilitates paperwork and workflow. Noblis’ staff ...
by:HingeClinica based inPrinceton, NEW JERSEY (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 from the pharmaceutical industry and clinical research ...
by:HingeClinica based inPrinceton, NEW JERSEY (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 ...
by:elminda Ltd. based inHerzliya, 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 endpoints, assisting in understanding drug mechanism, identifying ...
by:Freyr Solutions based inPrinceton, NEW JERSEY (USA)
After years of successful clinical research, submission of documents for Health Authority (HA) review requires a specialized skill of clear and precise clinical report writing. Such clear and precise clinical writing aids reviewers to easily comprehend the technicalities of clinical research, as a single error in clinical documentation may prove risky and costly for organizations, causing delays ...
Manufactured by:Imris Deerfield Imaging Inc. based inMinnetonka, MINNESOTA (USA)
IMRIS Clinical Applications Specialists are experts in integrating imaging modalities in the surgical environment. This knowledge is highly valuable when the proper use of imaging modalities is critical to the safety of patients and clinical staff. IMRIS Clinical Applications Specialists often provide consultation to surgical teams during procedures, leveraging their skills to implement best ...
Manufactured by:Invicro, LLC based inNeedham, MASSACHUSETTS (USA)
Radiopharmaceutical therapies represent an effective way to treat solid cancers by using tumor targeting small molecules, peptides or biologics to deliver a cytotoxic payload that induces DNA damage in tumor cells, while limiting damage to normal and healthy tissue. Streamlined development, evaluation and clinical translation of radiopharmaceuticals requires a partner that has extensive ...