Newsletter | May 9, 2012

05.09.12 -- Emerging CROs: One Step Forward And Two Steps Back

Clinical Leader
Emerging CROs: One Step Forward And Two Steps Back
By Rob Wright, Chief Editor, Life Science Leader magazine
By Rob Wright, Chief Editor, <u>Life Science Leader</u> magazine In discussions with executives in pharma and bio, emerging markets are a hot topic. No longer are emerging markets places where companies can expect to be successful simply by attempting to market products developed in other countries and then retrofitted to function in the developing country.
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Featured Articles

Changing The Outsourcing Paradigm
RDP takes a unique approach to the outsourcing of clinical services. The company employs strategies wherever possible to exceed the goals of its sponsors in cost and timelines while maintaining excellence in quality. Read more.

Proof Of Principal Confirmed In FIH/SAD Study
A top-50 biotechnology client needed a contract research organization clinical partner who could conduct a first-in-human/single-ascending-dose (FIH/SAD) study in healthy volunteers for an anti-inflammatory indication. The study evaluated whether the drug product was safe and well tolerated at dose levels that inhibit >50% of the ex vivo prostaglandin D2-induced eosinophil shape change in whole blood. Read more.

IND Preparation And Submission: Fast-Track Resubmittal Of Pre-IND
When a client's pre-IND submission was refused by the FDA, Camargo was engaged to quickly prepare and submit an FDA guidance-compliant pre-IND package. Camargo's team of regulatory experts tackled the task and completed it within three weeks. Read more.

Featured Multimedia
Video: Digital Signatures For Clinical Operations Demo

Video: Digital Signatures For Clinical Operations Demo

As the expense and time required for clinical trials continues to rise, sponsors and CROs are looking to technology for cutting process times, increasing efficiency, and reducing costs.

Featured Products
Point Of Care: Drug Abuse Testing
Blinded Diagnostics specializes in the application of point-of-care diagnostic platforms for testing patients enrolled in clinical trials. Their point-of-care drug abuse tests include tests for methadone, opiates, THC, and amphetamines. Read more.
Biological Asset Logistics
Marken has trained professionals with global expertise to protect and manage the logistics of biological assets such as sensitive drug supply and study specimens with expertise in tissue, ambient, refrigerated, and frozen assets. Read more.
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