Navigation Links
Agility Clinical Partners with PSR Orphan Drug Experts
Date:3/5/2013

CARLSBAD, Calif., March 5, 2013 /PRNewswire/ -- Agility Clinical, Inc., a specialty consulting and clinical research organization, has partnered with PSR Orphan Experts, a European orphan drug specialty consulting and clinical research company, based in the Netherlands, 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.

Carlsbad-based Agility Clinical and Netherlands-based 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.

"We're excited to mutually benefit from the collaboration and expertise of the two firms, and see a growing need in this important area," says Ellen Morgan , Agility CEO and 30-year industry veteran. "With few CROs focused on rare diseases, partnering with another like company to share knowledge and experiences strengthens our services to clients, and our reach." Prior to joining Agility, Morgan co-founded and was CEO and chairman of a California-based CRO that grew to over 300 employees and provided clinical services to hundreds of companies during her tenure.

"Given the current challenges in orphan drug development, it is of crucial importance to provide innovative & solid infrastructure and expert services," says Roger Legtenberg, CEO of PSR Orphan Experts. "By further strengthening the geographical reach for both companies to both sides of the Atlantic, we are able to provide an efficient clinical drug development strategy to our clients."

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.

About Agility Clinical
Agility Clinical, founded in April 2012, with an experienced executive management team whose mission is to help small and virtual pre-clinical and clinical stage companies develop drugs and devices, particularly in the orphan drug category. In addition to consulting, Agility provides customized full clinical trial services including project management, clinical operations, data management, biostatistics, medical, regulatory, and scientific affairs, medical writing and electronic source records (ESR). The Agility team has a true appreciation for the challenges its clients face in obtaining the expertise they need. The firm's senior staff volunteers time with its partner, the Public Health Alliance for Clinical Trials (PHACT), the first non-profit CRO dedicated to conducting clinical trials for products to treat diseases that affect the poorest people in developing countries. Agility has established operations in Carlsbad, CA. For more information, visit www.agility-clinical.com and http://www.phactcro.org.

About PSR Orphan Experts
PSR Group B.V., established in 1998, is a leading expert in orphan drug development in Europe. PSR assists companies to design and execute successful clinical development strategies for orphan indications, thereby specializing in complex clinical development programs requiring innovative regulatory and clinical approaches. PSR's services range from regulatory & clinical consultancy to full clinical research services (project management, monitoring, regulatory affairs, electronic data capture/data management and statistics/medical writing). For more information, please visit http://www.orphandrugexperts.com

Contact: Amy Zimmerman
A.Z. Communications
619-501-1875
amy@azcommunications.net


'/>"/>
SOURCE Agility Clinical, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Quebec Clinic Launches Canadian Use of Elektas Agility Beam-Shaping Innovation for Radiation Therapy of Cancer
2. Agility Clinical Expands Consulting Services to More Broadly Serve Small and Virtual Biopharma and Device Companies
3. Elekta to Showcase Revolutionary Agility Beam-shaping Innovation at Radiation Physics Annual Meeting
4. Austrian Medical Center Upgrades Cancer Treatment System, Improves Patient Care with Elektas Agility Beam-shaping Device
5. Pharma Clinical Trial Services: World Market 2013-2023
6. Synteract und Harrison Clinical Research vereinbaren die Gründung eines multinationalen Auftragsforschungsinstituts
7. Synteract and Harrison Clinical Research Close Deal to Form Multinational CRO
8. Citiustech Announces Launch of Bi-Clinical Cloud and App-Based Architecture
9. Elsevier Showcases Predictive Analytic and Clinical Integration Solutions at HIMSS13
10. Spring Bank Pharmaceuticals Closes $10.5 million Series A Financing to fund Phase I Clinical Trials in HCV-infected Patients
11. Independent Study Published in Clinical Infectious Diseases Highlights the Importance of Antimicrobial Removal Systems in Blood Culture to Rapidly and Accurately Aid in the Diagnosis of Sepsis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/5/2016)... , Feb. 5, 2016  Patients in Alabama ... focused ultrasound (HIFU) therapy no longer have to travel out ... its partnership with Urology Centers of Alabama to ... FDA-cleared procedure for qualifying patients. Alabama ... in the treatment of prostate cancer using many different modalities. ...
(Date:2/5/2016)... 5, 2016 Aethlon Medical, Inc. (Nasdaq: AEMD ... CEO, will be presenting at Source Capital Group,s 2016 Disruptive ... at 2:15 p.m. ET on Wednesday, February 10, ... discussion taking place at 3:15 p.m. ET. http://www.aethlonmedical.com ... hour after the conclusion of the live event. The panel ...
(Date:2/5/2016)... 5, 2016 Dehaier Medical Systems Ltd. ... "Company"), which develops, markets and sells medical devices ... China and international markets, today announced ... to concentrate the Company,s resources to develop its ... and to focus more on its major businesses. ...
Breaking Medicine Technology:
(Date:2/7/2016)... ... February 07, 2016 , ... HealthSmart Holdings, ... and organizations with the tools and information to lower the costs, and increase ... the cost of providing employee healthcare benefits by as much as 22%:, + ...
(Date:2/7/2016)... Scottsdale, AZ (PRWEB) , ... February 07, 2016 ... ... & Neck and Facial Plastics, has added Kybella® to his medical and surgical ... is a newly approved FDA injectable medication used as a non-surgical alternative for ...
(Date:2/6/2016)... , ... February 06, 2016 ... ... 303-368-6225 , MEDIA ADVISORY: 5000 PERIOPERATIVE NURSES EXPECTED AT AORN SURGICAL CONFERENCE ... perioperative nurses in the world with an estimated 5000 perioperative nurses in ...
(Date:2/6/2016)... ... February 06, 2016 , ... US Sports Camps is ... (YUCC) . This event brings together top non-profit leaders, ultimate organizations, and coaches from ... Ultimate”. Valerio Iani, Bay Area Disc Program Director of Youth and Education, describes this ...
(Date:2/6/2016)... Viejo, CA (PRWEB) , ... February 06, 2016 , ... ... quickly and easily add warm color grades to their footage. A LUT is a ... every pixel's color to the corresponding color indicated by the table. By manipulating each ...
Breaking Medicine News(10 mins):