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Clinical Regulations Services In Europe
12 services found
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, ...
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 ...
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: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, ...
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 ...
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 ...
by:Almac Group based inCraigavon, UNITED KINGDOM
Pharmacodynamic (PD) biomarkers are extremely important in early drug development trials and can be used to measure the level of response to an administered drug, whether it is biologically active & can help to determine target engagement and mechanism of action (MOA). PD Biomarkers assist investigators to understand if the drug is having the intended pharmacologic effect and be used to guide ...
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 ...