Clinlogix
, a clinical research organization located just outside Philadelphia, is taking steps to broaden the services they provide. In recent years, pharmaceutical, biotech, and medical device companies have begun to outsource portions, or all, of their clinical trials. With this recent trend, clinical research organizations have grown in importance as they help complete these clinical trials.
On October 1, 2012, Julie McCusker joined Clinlogix to kick-off their Safety Services.
“I am excited to be part of company with such integrity,” said Julie McCusker. “Product safety needs to get back to its roots of exceptional data quality, with the combination of people, process and technology. Clinlogix is poised to deliver high-quality, on time and on budget. Safety services for devices, products and drugs are quickly changing in the safety arena. From case processing through aggregate reporting and one-off safety projects, Clinlogix’s experienced project team, is client focused and delivers results.”
JeanMarie Markham, President and CEO of Clinlogix, stressed the importance of the new service saying, “As outsourcing continues to be the norm, and the proliferation of small biopharmaceutical and medical device companies continues, it is becoming increasingly imperative for companies to have a strategic partner that can provide a web-based safety management platform via a proven, validated technology such as Oracle Argus to successfully meet regulatory compliance, at an affordable price point. It is not sufficient, though to have the technology; it must be coupled with a highly skilled and proficient safety team to maximize the effectiveness of the program.”
Clinlogix uses Oracle Argus supported by Sentrx, the industry leaders in pharmacovigilance solutions. The safety system, coupled with our new Senior Director, Safety Services, will allow the company to compete in a new fiel
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.