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Clinical Regulations Services Available In Northern Ireland
19 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: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, ...
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: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: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 ...