Pharma outsourcer Almac has signed a deal that allows it to add emergency services to its clinical trial management platform, allowing sponsors to quickly handle unforeseen problems and minimize the need for unblinding data, the company said.
Under the agreement, Almac will couple its IXRS service, which allows clients to remotely manage trials, with partner ESMS' emergency response system. That gives sponsors immediate access to clinical assessments in the event of an emergency, allowing them to make rapid decisions to ensure patient safety and trial retention, Almac said.
In cases of extreme adverse reactions in clinical trials, physicians will often unblind a patient's data to better administer care, which forces the subject to drop out of the study and increases costs for sponsors. Almac says ESMS' 24-hour service is a means of reducing the need for emergency unblinding, as faster responses allow for better interventions.
"The strategic relationship we have formed with ESMS allows us to combine our knowledge and expertise to enable us to equip clinical trial sponsors with immediate access to information enabling them to make an instantaneous decision whether or not to unblind the patient, even in the absence of the principal investigator," Almac Clinical Technologies President Jim Murphy said in a statement. "This partnership is further evidence of our commitment to help sponsors get their new drugs to market faster by being innovative in all aspects of our service offering."
- read the statement