Criterium Inc.

Our vision is to conduct clinical trials better and more cost effectively than anyone else. We accomplish this by working with our clients to not only deliver the clinical trial effectively, on time and within budget, but also by leveraging our in-depth expertise to ensure the clinical trial is properly designed.

We believe there is increasing need for innovation, creativity and scientific expertise in clinical research, characteristics often synonymous with small Biopharma and hence, though we are proud to have a number of the world’s largest pharmaceutical companies as our clients, greater than 80% of our client portfolio is small Biopharma.

ACLIRES has performed trials for an international array of biotech companies as well as for some of the largest global pharmaceutical companies. With our broad access to patients and expertise, our aim is to rapidly initiate our client’s studies, even when a very special patient population is required.

Our services include:
- Early Phase Studies
- Late Phase Studies
- Recruitment
- Regulatory Affairs
- Monitoring
- Site Selection
- Scientific Services/Medical Writing
- Consulting
- Quality Management

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.

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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As consultants for the pharmaceutical, biotech and device industries we know that teams assembled around product development and clinical trials need more than a competent project manager and top technology to be successful at delivering according to plan.

To be successful, project teams in the health industry need a leader, with a strong medical and industry background, that will inspire, coordinate their efforts, and act as a single point of contact or reference for all involved; sponsors, sites, CROs, data & safety monitoring committee, clinical endpoint committee, special labs, IRB, FDA.

Anabase, founded by two MDs with both clinical practice and industry experience, provides independent, dedicated, hands on, medical and regulatory guidance to your product development and clinical trial projects.

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)
Philadelphia, Pennsylvania
Phoenix, Arizona
Belfast, Northern Ireland,UK
Zurich, Switzerland
Richmond, Virginia
Montreal, Quebec, Canada

For more information, visit: www.celerion.com