Celerion acts to meet demand for hospital-based US trials

14-Dec-2010 - Last updated on 14-Dec-2010 at 10:59 GMT

Celerion is partnering to access a medical centre Phase I unit that will support increased demand for trials conducted at US hospitals.

Allying with BryanLGH Health System, a non-profit healthcare organisation, gives Celerion use of 24 in-patient beds in a Lincoln, Nebraska, US hospital. The hospital provides Celerion with on site 24-hour emergency care, which was critical in the Northwick Park incident, and medical expertise.

Hospital-based clinical trial units are common in Europe, Philip Bach, vice president of clinical research at Celerion, told Outsourcing-Pharma, and demand is now increasing in the US.

Increased demand is driven, in part, by US Food and Drug Administration (FDA) pressure for certain types of medicine to be tested in a hospital environment, said Bach. This ensures safety infrastructure needed to handle serious adverse events is on site and operational 24/7.

Celerion and its clients will also benefit from the hospital’s medical expertise and technologies, such as chest X‐rays, PET (positron emission tomography) scans, and MRI (magnetic resonance imaging). These technologies will also support trials at Celerion’s existing Lincoln clinical facility.

Paperwork for the Celerion-BryanLGH Clinical Research Unit has been signed and the partners are now working to implement Celerion’s standard operating practices (SOP). Celerion intends to have this process complete and the site operational by March 2011.

Once operational the unit will perform early stage clinical trials of compounds from all therapeutic areas. The unit will be staffed by BryanLGH and Celerion employees, with the number from each organisation depending on the details of the clinical trial.

Repurposing a site

The hospital unit has been used for patient care for a number of years, Kimberly Russel, president and CEO of BryanLGH, told Outsourcing-Pharma, and is now being repurposed for clinical trials.

Partnering with Celerion expands activities at BryanLGH into clinical research, said Russel, and allows it to support a local company. BryanLGH operates 664-beds that serve patients throughout Nebraska and parts of Kansas, Iowa, South Dakota and other states in the region.