WIRB-Copernicus Group IRB and eClinical Experts to Present at the Site Solutions Summit
Sessions will discuss preparing for an FDA inspection, improving patient recruitment, and assessing site feasibility
PRINCETON, N.J., Oct. 10, 2014 – WIRB-Copernicus Group (WCG), the world’s largest provider of regulatory and ethical review services and software to support clinical research, announced today that Michelle Baptista, CIP, vice president of business development for its Aspire IRB and Lisa La Luna, senior vice president of business development at ePharmaSolutions, will be presenting at the Site Solutions Summit being held Oct. 10-12 in Amelia Island, Fla.
Ms. Baptista will co-host a mock FDA inspection entitled, “Are You REALLY Ready?” with three other presenters: Gary Yingling, Esq., partner at Morgan, Lewis, & Bockius; Michael Koren, MD, chief executive officer and clinical research investigator at the Jacksonville Center for Clinical Research; and Leah Andrews, FDA compliance consultant at Andrews Consultants.
“Preparation is the key to ensuring that a site has a positive FDA inspection and can continue to run its business smoothly at the same time,” said Ms. Baptista. “This workshop will help to ensure that participants are properly prepared for their next inspection and can successfully show their site performing at its best.”
This three-part, interactive workshop, which will be held from 1-4 p.m. EDT on Oct. 10, will give participants an opportunity to observe the inspectional process, review the complex documents involved, and learn how to best manage the logistical challenges that an inspection will create. Participants will take part in several simulated scenarios to determine best practices and ensure collective site success.
Ms. La Luna will be participating in two sessions on Oct. 11. She will lead the “SiteVoice” patient recruitment discussion entitled, “The Right Fit: Maximizing Patient Placement” at 3:15 p.m. EDT. Then, she will be a panelist in the session called, “Site Feasibility: Get it Right the First Time” about improving the site selection process at 4:45 p.m. EDT.
Three WCG companies are sponsors and exhibitors at this year’s Site Solutions Summit – Midlands IRB (booth #1), Aspire IRB (booth #24), and ePharmaSolutions (booth #33). Attendees will be able to see demonstrations of ePharmaSolutions’ SitePortal™, its new fully-validated, cloud-based, clinical trial portal for sites, in booth #33 during the show.
For more information on the Site Solutions Summit, please visit http://sitesolutionssummit.com.
About The WIRB-‐Copernicus Group
The WIRB-Copernicus Group (WCG) is the world’s largest and most trusted provider of regulatory and ethical review services for human research. The pioneer of independent ethical review, WCG continues to drive ingenuity in the clinical research space. Today, WCG’s solutions are built upon the foundation of ethical review, but have grown to include a suite of complementary services and technologies that expand the capabilities of the modern research professional. WCG delivers transformational solutions that stimulate growth, foster compliance, and maximize efficiency for those who perform clinical trials.
WCG is proud to serve the individuals on the frontlines of science and medicine, and the organizations that strive to develop new products and therapies to improve the quality of human health. It is our role to empower them to accelerate advancement, while ensuring that the risks of progress never outweigh the value of human life.
For more information, please visit www.wcgclinical.com.
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