Instem, a leading provider of IT solutions to the global early development healthcare market, announced today that BioKinetic Europe (“BioKinetic”) has deployed the ALPHADAS® clinical trials software solution in its Phase I unit located in Belfast, Ireland.
BioKinetic purchased ALPHADAS following a competitive evaluation of commercial software systems and vendors. Instem’s ALPHADAS software suite was chosen as the best solution on the market to help modernize processes, improve quality and further enhance the services BioKinetic provides to its sponsors.
A phased implementation approach began with a rapid deployment of the ALPHADAS Recruitment module during March 2016. This has enabled BioKinetic to more quickly and accurately dissect and search their patient database and has dramatically reduced the time taken to prepare proposals for new clinical studies as well as recruit for ongoing studies. The second phase of the implementation is now underway and BioKinetic expect to be capturing all clinical trial data electronically during Q1 2017. As part of this phase of the project, BioKinetic will also be utilising ALPHADAS’ ability to provide remote monitoring capabilities to clients and enable the direct delivery of fully SDTM compliant datasets.
“We are pleased and proud to now be powered by ALPHADAS,” comments David Bell, Medical Director at BioKinetic. “One of the most important elements of this project was to get our users trained and into live production within a very aggressive timeframe. The Instem Clinical staff really delivered, and along with our participation they led a collaborative and focused project team that enabled us to realize immediate benefits and returns on our investment.”
BioKinetic has completed over 400 clinical trials for global sponsor companies in Europe, North America and Asia, offering services covering a wide range of therapeutic areas. They work collaboratively with clinical research teams to design a program of early phase studies best suited to sponsors’ needs.
“Knowing we were replacing an existing system, while simultaneously introducing new process improvements across a wider application area, it was important for us to ensure our Rapid Deployment Model was organized and executed in manageable portions addressing the most pressing pain-points first,” states Gwen Aston, Senior Vice President at Instem Clinical. “Along the entire project route, our processes and services had been designed to safeguard the success criteria of BioKinetic’s project to deliver that very quick return on investment they required, while helping develop their longer term vision.”
BioKinetic users are accessing ALPHADAS over the Web via Instem’s professionally managed online platforms which are run from centralized state-of-the-art data centers and are being used by drug developers, contract research organizations, universities, research institutes and government agencies around the world.
Accessed on-site or via the Instem Cloud, the ALPHADAS software solution suite is a proactive early phase eSource data capture system with comprehensive CTMS capabilities. ALPHADAS is mobile, schedule-driven, and provides real-time bedside or station based direct data capture that virtually eliminates paper-based data.
About BioKinetic Europe
Based in Belfast, Ireland and formed in 1996, BioKinetic has been at the forefront of early phase drug development for over 20 years. The company has been steadily increasing in size, now employing over 50 full-time members of staff operating to the UK regulatory body’s (MHRA) highest standard of Supplementary Accreditation. BioKinetic Europe has developed a reputation for meticulously managed Phase I —III studies on behalf of pharmaceutical companies in Europe, Asia and the United States. BioKinetic is a FPM (Faculty of Pharmaceutical Medicine) approved educational training unit, with a range of Principal Investigators and Clinical Research Professionals with experience and expertise across all therapeutic areas.
Learn more about their mission at www.biokineticeurope.com
Instem is a leading supplier of IT applications and services to the early development healthcare market delivering compelling solutions for data collection, analysis and regulatory submissions management. Instem solutions are in use by customers worldwide, meeting the rapidlyexpanding needs of life science and healthcare organizations for data-driven decision making leading to safer, more effective products.
Instem’s portfolio of software solutions and consulting services increases client productivity by enhancing product development processes while offering the unique ability to generate new knowledge through the extraction and harmonization of actionable scientific information.
Instem supports over 500 clients through offices in the United States, United Kingdom, France, Japan, China and India.
For more information please visit www.instem.com
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Last updated on: 21/11/2016
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