The pharmaceutical landscape is constantly evolving, the ongoing growth of technology solutions within the clinical research sector presents new opportunities to engage more effectively with patients, enabling faster access to data, more accurate timely data and real-time oversight.

ESMS recognize that clinical technologies will only increase in use as time moves on and inevitably result in more patient lead devices being used to quantify clinical trial outcomes.

There is an ongoing need to identify and respond to patient safety needs quickly and efficiently. Potential adverse events can be identified and actioned more rapidly which may avoid an adverse event.

If we can work together to improve patient safety then ESMS would be interested in speaking with you. We believe opportunities exist in the following areas:

• ePRO
• IVRS/IRT
• EDC (Electronic Data Capture)

ESMS are continuously developing services to enhance patient safety in clinical research. To talk to us more about partnering on our 24/7 emergency information services to include medical escalation, please contact us.

Almac and ESMS Global collaborate to offer unique Clinical Trial Support
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, the 24/7 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 Principal 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 two great IRT solutions Simplify and IXRS 3 (Almac’s fully customizable Interactive Response Technology service) 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 Principal Investigator.” says Val Higgins, President & Managing Director of Almac’s Clinical Technologies.

“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.”

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.

Almac, a privately owned international organization has grown organically over 30 years and now employs in excess of 3,500 highly skilled personnel. Almac has its headquarters in Craigavon, Northern Ireland, with operations across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).

For more information visit www.almacgroup.com or e-mail media@almacgroup.com