|By Business Wire||
|May 27, 2014 10:02 AM EDT||
Ximedica, provider of comprehensive product development services to leading medical device, pharmaceutical and healthcare companies announced significant additions to its Human Factors and product testing research capabilities. From upgrades to processes, the addition of 4 new observation rooms in its 2 U.S. locations and the hiring of senior team members, Ximedica is poised to meet the increased industry need for Human Factors Evaluations that are tailored to the level of rigor required by clients and partners.
Says Aidan Petrie, Chief Innovation and Co-founder, “We have always driven our business to meet the needs of our clients and as this base grows to include emergent start-ups, established medical device manufacturers and now pharmaceutical companies it is more and more evident that there is no one size fits all in usability studies due to variety of subjects, the wide variety of programs and the increasing burden put upon them by different regulatory bodies. It was a simple decision to review and redraft a number of our SOPs related predominantly to research practices and Human Subject Protection that allow us to provide the right level of rigor for each study while maintaining a competitive cost structure. We believe this is an unprecedented offering in the landscape of Human Factors/Usability service providers today.”
To further support this need for studies Ximedica has built out four observation rooms onsite in its Providence and Minneapolis that allow sophisticated video recording and streaming in a controlled environment. In addition the team has added five new members in the past 6 months including a Human Factors veteran from Siemens Healthcare and a clinical expert.
Michael Pereira, SVP, Technology & Operations oversaw the upgrade to the SOP’s and notes, “Offering different levels of rigor associated with our Human Factors and Usability capabilities is simply another move in keeping with our flexible and nimble processes that can be tailored to meet the needs of the organizations we partner with on straightforward assignments to being able to meet the highest rigors required by our pharmaceutical clients.”
Core to these updates is the adoption of a formalized process on how to plan, conduct, analyze and report human research studies aligned with GCP standards.
“Our research practices have always applied the rigor needed for protection of participants and high quality data, but by codifying these practices in our SOPs, we have strengthened our ability to manage human research according to established principles of ethical conduct and methods of ensuring scientific integrity of the process and data generated. This adds considerably to the trust we have already built with clients and with regulatory authorities that review our work,” States Tom Varricchione, SVP, Clinical & Regulatory Affairs.
Recent changes encompass the following:
- Ability to identify early and subsequently tailor the levels of controls on a study to clients’ needs from the outset
- Policies regarding privacy, scientific misconduct
- Appropriate controls for protection of health information (data encryption etc.)
- Required training on our human subject study (HSS) procedures
- Onsite observational facilities and Usability Labs that ensure tighter control of data protection and cost control
Ximedica is a full service ISO 13485 certified and FDA registered product development firm with an exclusive focus on medical products. With more than 25 years of experience developing medical devices, combination products and consumer healthcare products our client base spans the globe and ranges from start-ups to the world's largest OEMs. www.ximedica.com
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