Sponsors Requesting 24/7 Medical Support & Emergency Unblinding can Save Time and Money
In a unique partnership arrangement, Almac, a global leader in advanced clinical technology and support services for the pharmaceutical and biotech industries, and ESMS, the24/7 medical emergency response service for clinical trials have combined their expert knowledge and decades of experience to offer clients an exclusive solution surrounding emergency unblinding procedures.
In compliance with E6 Good Clinical Practice (GCP) regulations [section 5.13], this unique partnership provides clinical trial sponsors immediate access to the clinical assessment for and, if deemed appropriate, emergency unblinding procedures to support patient safety even if the Principle Investigator is not physically present with the patient. This unique service results in reduced time, effort and disturbance to the study subject involved thereby guaranteeing patient retention at an optimum level and global capture of safety reports.
Almac's fully customizable Interactive Response Technology service (IXRS®) enables clients to manage key aspects of their clinical trials, including randomization, dosing, drug/clinical supplies inventory management and electronic Patient Reported Outcomes (ePRO) via phone or web. Coupling this innovative solution to ESMS' 24/7 emergency response service provides instantaneous and continuous support, which exceed regulatory requirements, thereby offering sponsors complete confidence should subjects with adverse events require medical support or an emergency unblind scenario occur.
As a result of the combined clinical knowledge base and expertise offered, typically from 95% of calls where emergency unblinding is initially requested, only 5% are actually performed. This reduces the significant expenditure concerned with acquiring new patients to ensure the trial is not compromised.
"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 principle investigator." says Jim Murphy, President of Almac's Clinical Technologies business unit "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."
Rita Fitzpatrick, ESMS General Manager commented on the collaboration "We are delighted to team up with Almac to provide this level of support and service to our global clients."
Find out more about Almac's IXRS service offering by visiting http://www.almacgroup.com/clinical-technologies/ixrs/
'Partnering to Advance Human Health'
The Almac Group is an established contract development and manufacturing organization that provides an extensive range of integrated services to over 600 companies globally within the pharmaceutical and biotech sectors. The services range from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.
The international company is a privately owned organization that has organically grown over 30 years and now employs in excess of 3,500 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).
Visit www.almacgroup.com e-mail [email protected]
Spanning five decades of service ESMS Global, provides extra peace of mind for all aspects of patient drug safety, from adverse event management and reporting, product complaints and defects through to the management and reporting of trial subject unblinding requests.
Described by the MHRA as "a center of excellence" and providing "a superior service", ESMS provide 24/7 emergency information services for clinical trials, specializing in a robust and reliable continuous service.