Clinical Trials

Report: Record Number of Diabetes Clinical Trials in the Pipeline

Research firm Profil Institute reports burgeoning demand for clinical drug trials.

Profil Institute for Clinical Research, Inc., a company focused on early phase clinical trials for diabetes and obesity, announced today record growth in the number of clinical trials in the pipeline.  Profil Institute also reports an increase in the number of mid-size biotech and off-shore clients, while maintaining active collaborations with the largest global pharmaceutical companies, driven by a strong demand for Phase I and metabolic disease specialization. 

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Critical Aspects of Clinical Trial Packaging

Packaging service and technology providers support stringent trial needs with unit-dose packaging, cold-chain support.

By Marie Redding
Freelance Writer

Not much changes very often, or very quickly, in the world of pharmaceuticals—or in regards to packaging for clinical trials—but there are a few trends.

“In the past, we were mainly focused on clinical trials for solid-dose drugs,” says Manfred Zurkirch, CEO, Körber Medipak/Dividella. “In recent years, however, more injectable liquids are being tested,” he says.

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Almac Doubles Analytical Capacity in US Headquarters

Almac announced the doubling of analytical capacity at its 240,000 sq. ft. North American Headquarters. The facility, built on a 40 acre site in Souderton, PA, north of Philadelphia, and occupied since 2010, delivers full-service, integrated clinical packaging, drug supply management, and technology solutions to pharmaceutical and biotech clients.

Catalent Pharma To Acquire Aptuit’s Clinical Trials Supplies Business

Catalent Pharma Solutions, Inc., and Aptuit, LLC, announced an agreement for Catalent to acquire the clinical trial supplies business of Aptuit LLC for $410 million on a cash and debt free basis. The acquisition will expand Catalent’s Development & Clinical Services business, transforming it into the number two provider globally in clinical supply solutions.

Almac's Clinical Business Unit Recognized by the American Society for Quality

Almac’s Clinical Services business unit has been recognized with the ‘ASQ Philadelphia Section Large Company Member of the Year’ award. The American Society for Quality is a global authority on quality representing more than 85,000 members worldwide. The Philadelphia Section is one of the largest and most active of ASQ’s 250 sections, according to a press release issued by Almac.

Catalent Pharma Solutions Expands Its Clinical Supply Services

Catalent Pharma Solutions has announced two global expansion initiatives for its Clinical Supply Services business.

In the United States, Catalent’s Philadelphia site has just completed a 3000-sq-ft cage expansion to accommodate DEA Schedule III-V drugs and other special security storage needs. According to a press release, the expansion will provide 500 additional storage locations to existing capacity and offer additional storage, distribution, and return drug management capabilities.

Changes Affect Clinical Trials

By Marie Redding
Freelance Writer

Clinical trials are a critical step in the approval process for new drugs. Every detail is preplanned and closely monitored during the trial. Packaging plays an important role and can have an effect on patient compliance as well as the outcome of the trial.

FDA’s Center for Drug Evaluation and Research (CDER) continues to look for ways to improve the drug approval process, and recently presented a seminar in which some of the issues surrounding clinical trials were discussed.

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Almac and Exco InTouch Form Alliance to Deliver Patient Compliance

The Almac Group and Exco InTouch announced today that Almac’s Clinical Technologies business unit, the leading provider of IXRS® (Interactive Voice and Web Response) services relating to patient and drug supply management, has formed an exclusive integrated patient management alliance with Exco InTouch, an innovative firm specializing in patient recruitment, retention, compliance and ePRO services.
 
The alliance will be focused on the integration of both technology and processes by both firms to deliver patient management, compliance, retention, and

Catalent Pharma Solutions Enhances Global Sourcing

Catalent Pharma Solutions's global network of sourcing specialists will now enable the company to supply comparator drugs directly from manufacturers. The company expects to be able to reduce customer costs and ensure timely initiation and reliability of product supply.
 

Almac Readies Integrated Clinical Trial Facility In Pennsylvania

Almac said it is nearing completion on its new North American Headquarters in Souderton, Montgomery County, PA. The facility will usher in a new era of holistic execution of clinical trial services, supporting a state of integrated clinical supply and technology excellence that the company calls Pharmony.

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