A pharmaceutical company develops and commercializes innovative targeted oncology treatments to address major unmet medical needs and advance cancer care. Founded in 2006 and headquartered in Portland, Oregon, this company is pioneering research in the field with several drugs in the pipeline, one of which is already FDA approved.
Sequenom is a life sciences company committed to improving healthcare through revolutionary genomic and genetic analysis solutions. The medical device company, founded in 1994 and headquartered in San Diego, CA, develops innovative technologies, products, and diagnostic tests that target and serve discovery, clinical research, and molecular diagnostic markets.
Logistics can be one of the most complex aspects of successful clinical trials because samples shipped from study sites for testing at a central laboratory must be maintained within a very limited temperature range. Cold chain or refrigerated logistics, where temperature is controlled in the shipping environment, often brings added challenges and expense. LabConnect provides validated cold-chain solutions, however controlled ambient shipping solutions are becoming more important in cases where whole blood samples are required by the testing laboratories. This is seen most readily in PBMC and other analyses where high cellular viability and yields are critical.
In January 2013, SynteractHCR began working with Tacere Therapeutics (A Benitec Biopharma company) to prepare for an NIH Recombinant DNA Advisory Committee (RAC) meeting prior to submitting an Investigational New Drug (IND) application to the FDA for its TT-034 Hepatitis C therapy.
Often, early-development stage companies are working on pharmaceuticals and medical devices that have promising clinical intellectual property and commercial prospects. They may even have large pharma partners that help with financing and, eventually, submissions around the world. But in the beginning of trial phases they are often working with shoe-string budgets and simply trying to see if the innovative product will be efficacious.
SynteractHCR is a privately held contract research organization (CRO) dedicated to meeting the needs of biotech, pharmaceutical and medical device companies.
SynteractHCR, Inc. was sought out by sponsor MediciNova, a publicly traded biopharmaceutical company headquartered in San Diego, for assistance on a Phase 2 asthma trial, MN-221 Cl-007: A Phase 2, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of MN-221 in adults with acute exacerbations of asthma.
Using automated workflows that track process steps and completion dates results in better communication, increased productivity, simplified data gathering, and enhanced visibility to study startup status.
Using purpose-built tools to track and manage document exchanges and other study startup tasks results in reduced activation times.
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