June 1, 2011
Improving Insight and Increasing Control of Temperature-Sensitive Supplies in Clinical Trials

Improving Insight and Increasing Control of Temperature-Sensitive Supplies in Clinical Trials

Demand for temperature-controlled distribution has increased steadily over the past few years, as a result of the increased use of biologics and the proliferation of clinical trial conduct in emerging markets.

The need for temperature control and monitoring does not end with the storage of products. To ensure the quality of temperature-sensitive supplies, accurate temperature monitoring throughout the distribution cycle is a must. Rapid access to temperature data from these shipments is essential for cost and time savings.

During this webinar, speakers involved will introduce a unique web-based solution for gaining rapid insight into temperature-sensitive shipments in clinical trials. Shipping Temperature Electronic Monitoring System, STEMS, was launched by Almac in late February 2010. Using USB-enabled temperature monitors, STEMS allows for online upload of temperature results upon shipment arrival, making temperature reports available for review in real-time.

       Join us for a closer look at STEMS

       - Comparison of report turn-time on traditional monitors and STEMS
         compatible devices
       - Benefits of online review
       - Areas for cost-savings
       - Technical requirements for use
       - Overview of the STEMS process

• Senior level executives from global pharma / biotech companies involved in the outsourcing of formulation development and clinical supply manufacturing.
• Procurement Managers

Shirley Attryde graduated from Arizona State University in 1996. She started in clinical trials with MDS Harris (now Celerion) and continued to expand her clinical conduct experience at other research facilities. She has spent over nine years working in the clinical trial industry. Shirley commenced employment with Almac in 2005, serving in various project management roles. She was appointed the role of Product Manager for STEMS in 2009. She was named the first ACE (Almac Celebrates Excellence) Ambassador for the Durham, NC facility in September 2010.

Providing a wide range of drug development and clinical trial supply services, Almac assists global Pharma and Biotech companies reach their critical clinical milestones and ultimately commercialisation.

Offering innovative pharmaceutical development services for solid oral dose drug products, Almac can work with client partners to produce an optimum formulation and manufacture clinical batches from initial First in Human supplies to phase IV / registration.

Following your protocol designs, Almac can additionally provide a range of solutions for blinding and over-encapsulation from single tablet filling to multiple mixed input units and controlled powder / excipient dosing.

Almac has invested heavily in these service areas to ensure recognition as a market leader. With processing capabilities ranging from small-scale manual filling of capsules to large-scale fully / semi automated technology, Almac ensures high quality, efficient clinical supplies to meet client / clinical requirements.