April 19, 2014 4:52 PM ET

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Company Overview of Agility Clinical, Inc.

Company Overview

Agility Clinical, Inc., a contract research organization, provides clinical trial services. The company offers project management services, including project feasibility, study budget and timeline management, study tracking reports, risk assessment, mitigation, and vendor management; clinical operations services, such as investigator selection, regulatory document collection and submission, TMF set up and maintenance, clinical monitoring, and site management; and data management services, which include database design and validation, data cleaning, and EDC. It also provides biostatistics, such as protocol review and study designing, sample size determination, statistical analysis planning, D...

7220 Avenida Encinas

Suite 208

Carlsbad, CA 92011

United States

Founded in 2012

Phone:

760-520-0395

Fax:

760-520-0608

Key Executives for Agility Clinical, Inc.

Chief Executive Officer
Vice President of Business Operations
Vice President of Medical
Vice President of Biometrics
Vice President of Project Management and Clinical Operations
Compensation as of Fiscal Year 2013.

Agility Clinical, Inc. Key Developments

Agility Clinical, Inc. Partners with PSR Group B.V. Orphan Drug Experts

Agility Clinical, Inc. has partnered with PSR Group B.V. Orphan Experts, a move that will provide clients with access to orphan drug development expertise and services on both sides of the Atlantic. The term "orphan drug" refers to pharmaceutical products developed specifically to treat rare diseases. A rare disease is one that affects fewer than 200,000 Americans or less than one in 2,000 Europeans. Agility Clinical and PSR specialize in orphan drug development, helping pre-clinical and clinical stage companies, by providing strategic and operational consulting support, in addition to traditional CRO services. Both firms specialize in developing complex clinical development programs that require innovative regulatory and clinical development approaches. The number of rare diseases for which no treatment is currently available is estimated at approximately 6,800, according to the National Institute of Health (NIH). Nearly 30 million Americans, almost 1 in 10, are affected by a rare disease. Orphan drugs present fundamentally different regulatory and operational challenges than their traditional drug counterparts. Agility and PSR both specialize in helping companies develop efficiencies and economies of scale to help patients with rare diseases by bringing innovative new drugs and devices to market.

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