CLINARTIS, LLC
HOLLYWOOD, FLORIDA

Clinartis is a performance-based clinical research service provider with access to the best clinical researchers in the United States, the Baltics and Eastern Europe. Clinartis is entirely focused on delivering projects through a collaborative and personalized approach. Our expertise in specific therapeutic areas and specialized technologies provides the foundation for navigating the complexities of product development. Our foundation is based on quality and performance, every project is carefully analyzed at every step to ensure performance objectives are being attained with the best quality delivered. To make a difference in the lives of patients, our partners, employees and community through the passionate pursuit of the development of innovative healthcare products. Mission Clinartis strives to deliver exceptional services to our partners supporting their product development efforts on a global basis. At Clinartis our policy is to provide innovative clinical trial, regulatory and compliance management services that meet or exceed the critical needs of our customers. We are Clinartis drives our company culture through a strong foundation of core values: Maintain a spirit of doing more with less passing on our effectiveness to our partners in delivering cost effective product development solutions Create a philosophy of lifelong learning to continuously advance our companies growth and development Clinartis is always looking for great clinical talent for permanent or contract positions. Please email your CV and a description of your desired position to [email protected] Medrio, a leading Software as a Service (SaaS) company providing cloud-based data management capabilities to clinical researchers, and Clinartis, a contract research organization (CRO) providing clinical trial services in the United States and Europe, have announced a new partnership under Medrio's Partner Program. Medrio, a leading Software as a Service (SaaS) company providing cloud-based data management capabilities to clinical researchers, and Clinartis, a contract research organization (CRO) providing clinical trial services in the United States and Europe, have announced a new partnership under Medrio’s Partner Program. US Food and Drug Administration (FDA) has completed a successful inspection of pivotal clinical study of a biosimilar product managed by CLINARTIS. NO Form 483 observations were issued. Clinartis initiated multi-cohort Single-Ascending Dose (SAD) clinical trial for novel antibacterial agent for the treatment of infectious diseases. Clinartis initiated clinical trial in renally impaired and end stage renal disease patients on hemodialysis patients as part of 505(b)(2) program. US Food and Drug Administration (FDA) completed review of a Clinical Protocol prepared by CLINARTIS team as a part IND submission for novel antibacterial combination product for the treatment of pneumonia, febrile neutropenia, urinary tract infections, uncomplicated skin and skin structure infections. The clinical research trial conducted by CLINARTIS successfully passed US Food and Drug Administration (FDA) Inspection at our Sponsor’s facility as a part of FDA’s Bioresearch Monitoring Program. CLINARTIS participated in AAPS Annual Meeting and Exposition is Orlando, FL. Clinartis has completed Clinical Study Report for a pivotal clinical study of a biosimilar product. Clinartis has completed site close out visit of alcohol-interaction study in Canada. Clinartis meets with top clinical research investigators at the 2015 Annual Meeting of the American Society of Clinical Psychopharmacology to discuss upcoming clinical studies in schizophrenic subjects. Clinartis initiated two clinical trials in patients with mild, moderate and severe hepatic impairment for a 505(b)(2) program. Clinartis initiated two clinical trials in patients with mild, moderate and severe renal impairment for 505(b)(2) program. Clinartis has launched a pivotal clinical trial of a biosimilar product in comparison with an FDA-approved biological reference product. Clinartis completed an early phase clinical trial with four-way crossover replicated design of a novel inhalation aerosol product for 505(b) (2) NDA submission Clinartis has obtained FDA review and agreement on a clinical trial protocol for the safety study in special population. Clinartis has met enrolment milestone in a Phase I pharmacokinetic study of a novel antibiotic product in patients with mild to severe hepatic impairment. Clinartis has completed subject recruitment in a clinical trial of a novel antibiotic against MRSA to evaluate pharmacokinetics in epithelial lining fluid (ELF) and alveolar macrophage (AM) cells in bronchoalveolar lavage samples. Clinartis completed early phase clinical trial with four-way crossover replicated design of dry powder inhaler product for ANDA submission. Clinartis has completed clinical study report for the clinical trial evaluating safety, tolerability and pharmacokinetics of multiple escalating doses of intravenous novel antibiotic. Clinartis has been appointed by the European stem cells biotech company to facilitate its communication with the FDA for the development of a novel gene-therapy drug product for seeking US marketing authorization. Pre-IND meeting package will be compiled and submitted to CBER/OCTGT at FDA to discuss specific questions related to the preclinical and clinical development program for the gene-therapy drug product, intended for the treatment of peripheral arterial disease. Clinartis has entered into a collaborative partnership with a European pharmaceutical company for the regulatory strategy and clinical development program of a novel anti-influenza product. The program aims conduct of global phase II-III clinical trials in Northern and Southern hemispheres for seeking worldwide marketing approval. Clinartis completed enrollment in a skin irritation and sensitization study of a novel transdermal delivery system for the treatment of postmenopausal symptoms.