Project Management White Papers & Case Studies
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Perception And Reality At CROs
4/19/2013
It’s hard to avoid CROs these days. From two-person virtual companies to the largest multinationals, everyone is outsourcing, and like everything else, this trend has its pluses and minuses. By Bruce N. Rehlaender, Ph.D., Director, Formulation Development, PharmaDirections, Inc.
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Maxxam Analytics Stays Ahead Of The Market With CoSign Digital Signatures
2/28/2013
Maxxam Analytics is the market leader in analytical services and solutions to the energy, environmental, food and DNA industries.
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Improving Life Science Operations With Digital Signatures eBook
2/27/2013
Today, 8 of the top 10 pharmas and 6 of the top 10 CROs use ARX’s CoSign® digital signature solution to help them benefit from fully electronic regulatory document lifecycles, compliance with various FDA GxP regulations, and efficiency in supporting audits.
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Phase II Primary Insomnia Program In Need Of Full-Service CRO Management
12/6/2012
Clinilabs, a contract research organization (CRO), was selected by an international drug discovery and development company to provide full-service CRO management of a phase II primary insomnia program.
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Ethnic Bridging
10/26/2012
Clinilabs, a contract research organization (CRO), was selected to characterize the pharmacokinetic prole of XXXX following the administration of four doses of XXXX to healthy Japanese and non-Japanese subjects aged 20 to 45 years by assessing serum concentration data over time.
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Therapeutic Expertise: Neuroscience & CNS Datasheet
3/27/2012
PRA is a leader in the clinical research industry, providing innovative solutions for CNS drug development.
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Persistence Leads To High Enrollment: PRA Convinces Client To Stick With Recruitment Strategies
2/21/2012
PRA was contracted by a large biotech client to evaluate the immunogenicity of a flu vaccine in adult subjects with rheumatoid arthritis. From the start, the PRA study team faced a shortened enrollment period and other timeline challenges, including the protocol’s late delivery as well as problems with the vaccine’s availability.
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PRA Exceeds Tough Enrollment Goals: Service Delivery Model Drives Positive Results
2/20/2012
Changes in resources for both the client and PRA teams led to significant challenges with the start-up and enrollment activities in Europe and North America.
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Human ADME & Studies With Radiolabeled Compounds
During clinical drug development there can be several situations where the use of radiolabeled medication or other radiolabeled compounds is required or favorable to accomplish the study objectives. This whitepaper is mainly focusing on human ADME studies and “microdose” studies to assess absolute bioavailability (BA). The major part of the information in this overview is also relevant for other clinical studies with a radiolabeled compound. By Ad Roffel and Henk Poelman, PRA Health Sciences