The need for clinical data is essential in proving clinical evidence for medical products, and to better understand device safety and effectiveness after clearance or approval.
(PRWEB) March 26, 2015
Ale Gicqueau, Founder and President of Clinovo, will co-present with Victor Chen, Director of Clinical Affairs at Align Technology, on “Conducting Postmarket Registries - Rationale and Execution” at the upcoming ACRP 2015 Global Conference and Exhibition on April 25th through April 28th in Salt Lake City, Utah.
During the poster presentation, Ale Gicqueau and Victor Chen will discuss the rationale for creating and running a Postmarket Registry, the requirements and resources to conduct the registry, as well as understanding the available cost-efficient clinical databases and how to choose from wide range of solutions.
This presentation is well suited for clinical trial experts looking to gain insight on the potential benefit of post market registries, and the options available to set up and execute a clinical database in a cost-effective manner. “The need for clinical data is essential in proving clinical evidence for medical products, and to better understand device safety and effectiveness after clearance or approval”, said Ale Gicqueau, President of Clinovo. “Clinical trials are becoming cost prohibitive, as trials are required to follow Good Clinical Practice. Clinical registries provide real-life exposure to the use of the device, and can provide valuable clinical data, if designed appropriately.”
Ale Gicqueau is a Founder and President of Clinovo, a leading provider of cloud-based eClinical software. With over 10 years of experience in Clinical Data Management, Ale Gicqueau is an expert in clinical databases, from design to implementation, as well as the regulations surrounding data collection and compliance.
Victor Chen is a Director of Clinical Affairs at Aligh Technology, a global medical device company that pioneered the invisible orthodontics market. With over 25 years in clinical research, Victor Chen has designed and executed more than 30 clinical trials in pre and post market settings, with 2 PMA approvals, several 510k clearances, and numerous publications.
The Association of Clinical Research Professional (ACRP) Global Conference and Exhibition is the largest annual clinical research conference uniquely focused on supporting the professional growth and development of individuals conducting clinical trials through education, exchange, and peer-to-peer engagement. Each year, the conference brings together more than 2,000 of professionals to network and exchange ideas, best practices, and more.
Clinovo is a leading provider of cloud-based eClinical software. Clinovo’s flagship solution ClinCapture® is the only validated electronic data capture software, available for free. ClinCapture empowers CROs, Pharmaceuticals and Medical Device companies to build studies themselves, lower their clinical trials costs and streamline their data capture processes. Clinovo is headquartered in the Silicon Valley.
About Align Technology
Align Technology is a global medical device company with industry-leading innovative products such as Invisalign clear aligners, iTero Intraoral scanners, and OrthoCAD digital services that help dental professionals achieve the clinical results they expect and deliver effective, cutting-edge dental options to their patients.
Founded in 1976, ACRP supports clinical research professionals through membership, training and development, and certification. ACRP is the leading organization championing the interests and perspectives of clinical research professionals. ACRP plays an active role in public discourse of clinical research and in raising awareness of the issues important to clinical research professionals.
Sophie McCallum | Director of Operations
sophie(dot)mccallum(at)clinovo(dot)com | +1 (408) 773 6258