Amarex is a global, full-service Contract Research Organization (CRO), whose leadership team has significant expertise conducting biomedical research, and whose combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides comprehensive services in Project Management (Phase I-IV, BE/BA, PK/PD), Regulatory Affairs (FDA Applications and meetings, Applications to International Health Authorities, GxP Compliance Audits), Clinical Operations, Adaptive Study Designs, Statistical Analysis, Data Management, Medical Monitoring, Safety and Pharmacovigilance, and General Consulting. Amarex can take your product through the entire approval process, from creating the regulatory approval strategy, to conducting trials, to writing the marketing approval application. Join our growing list of clients with approved products. Amarex provides high quality and cost efficient services.
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Allphase Clinical Research is a full-service clinical development company providing clinical trial management services, including regulatory affairs, project management, clinical monitoring, data management, quality assurance auditing, drug safety, and medical writing. Allphase provides Phase I to IV support throughout a wide range of therapeutic areas, with a predominant focus in oncology, CNS, and critical care diseases.
Allphase provides integrative and strategic clinical trial services that allow our international partners to realize the advantages of conducting clinical trails in North America, while reinforcing therir global development cpabilities.
Biostat International, Inc., is a contract research organization designed to meet the needs of device and pharmaceutical companies by providing a full range of product development services. Since its founding in 1994, BSI has delivered quality biostatistical and data management services and has expanded into project management, clinical monitoring, and medical writing. Its sincere devotion to quality, personal attention, support and commitment has made BSI a client-favorite CRO. The rED Cap system design is based on the CDISC Operational Data Model (ODM) (http://www.cdisc.org/site/index.php), and features multiple layouts for eCRFs, powerful data validation capabilities for increased data quality, and an easy and intuitive process for clinical site coordinators to enter data and manage query tasks. It also allows Monitors to keep up to date with source verification and data entry status, and sponsors to view data and custom reports. BSI offers the rED Cap tool to its clients interested in data management services where BSI statisticians provide ongoing trending and review of data entered into rED Cap. Cost effectiveness and transparent work accountability are important components of all of our service.
Celerion, a leader in early clinical research, delivers Applied Translational Medicine. Celerion applies our expertise and experience to translating information gained in research discoveries, to knowledge of drug action and effect in humans to support early drug development decisions and the clinical pharmacology labeling of new medicines.
With over 40 years of experience and 600 global clinic beds (including 24 in-hospital), Celerion conducts and analyzes First-in-Human, clinical proof-of-concept, cardiovascular safety (TQT, robust QT), ADME and NDA-enabling clinical pharmacology studies. Celerion provides expertise on modeling and simulation, study design, medical writing (protocols and reports), clinical data sciences, biostatistics, and PK/PD analysis as well as small and large molecule bioanalytical assays through clinical drug development. Regulatory, drug development and program management complement Celerion’s service offerings.
Our operations are strategically located in:
Lincoln, Nebraska (Corporate Headquarters)
Belfast, Northern Ireland,UK
Montreal, Quebec, Canada
Our goal is to assist you to properly plan and execute your clinical strategy to assure early FDA approval and expedite your product to market.
Clinstat Consulting was founded in 1999 by Patricia Hamilton, RN, MS.
Patricia is a clinical expert with over 25 years experience. She is a Registered Nurse and holds a Master's Degree in Business Management. She has had extensive senior level technical and management experience delivering clinical research plans and studies on time and within budget for Fortune 500 global corporations as well as for small companies and start-ups. She has set up and managed clinical departments from the ground level and has hands on experience in all phases of developing a clinical/regulatory strategy, securing investigators, site selection, protocol development, site monitoring, generation of final reports and writing FDA submissions. Patricia and her staff are well suited to guide start-up companies or assist established firms with any or all your clinical needs.