Clinical Regulations Services
25 services found
Manufactured by:Avania based inBrunswick, AUSTRALIA
In tandem with preclinical strategy development, partner with us for a clinical program strategy that will move your product ...
by:Phortas GmbH based inAachen, 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, ...
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:GenomeMe Lab Inc. based inRichmond, BRITISH COLUMBIA (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 ...
Manufactured by:Bracco Spa based inMilan, 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. ...
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:Envigo based inCambridgeshire, 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, demonstrating safety at many times the human dose in animals, ...
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 ...
Manufactured by:Medexter Healthcare based inVienna, AUSTRIA
Arden Syntax is a language for the representation and processing of clinical knowledge in a standardized way. Our ArdenSuite is based on this syntax. The software suite is a powerful tool that will help shape the future of healthcare information technology. As it is extremely versatile and flexible, it can be applied to a grand variety of clinical tasks and has proven an effective way to ...
Manufactured by:Avania based inBrunswick, 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 ...
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 GCP guidelines. We strive to be responsive, flexible and mindful throughout the trial ...
by:F. Hoffmann-La Roche Ltd. based inBasel, 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 order to gain marketing approval and, ultimately ...
by:OracleBio based inGlasgow, 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 clinical-trial data are credible (EMA Website). For ...
by:International Drug Development Institute (IDDI) based inLouvain-la-Neuve, 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 study designs, best practice randomization methods, regular ...