The 10th Clinical Quality Oversight Forum offer and in-depth education on risk-based approaches for selecting, managing and monitoring clinical vendors and sites. The forum attracts senior-level clinical quality and operations professionals from leading pharma, biotech and device companies of varying size, making it an ideal event for networking and forming new business relationships. For additional information on sponsoring or exhibiting opportunities, contact Arthur Butler at 917-932-0429 or email@example.com.
Caligor Coghlan is a premier pharmaceutical and biotechnology services company specializing in clinical supply chain management from commercial drug sourcing and supply of comparators, standard of care therapies, rescue medicines, adjunctive care, medical devices, and ancillaries as well as providing full-service secondary clinical packaging, labeling, kitting, randomization, global distribution, storage, returns, and destruction for both investigational and commercial products. Caligor Coghlan also serves its clients’ global access needs, providing expertise, consultation and innovative solutions for named patient, expanded access, early access, post-trial access, and compassionate use programs
CluePoints® is a Risk-Based Monitoring and Central Statistical Monitoring solution that has been designed and perfected over the last 15 years. It employs unique statistical algorithms to determine the quality, accuracy, and integrity of clinical trial data both during and after study conduct. Aligned with guidance from the ICH, FDA, and EMA, CluePoints® is deployed to support traditional on-site monitoring, medical review and to drive a Risk-Based Monitoring strategy.
DArcy Consulting was established in 2014 to provide practical support for clinical compliance/ clinical quality functions. We are a Clinical Compliance Consulting Company with a singular focus on building compliance cultures for Life Science companies. One of our major areas of focus is Inspection Readiness: we conduct gap assessments to determine what is needed to ensure inspection success, e.g., Developing SOPs, Developing Training (GCP, Inspection Readiness), Building Quality Management frameworks & supporting processes, Creating Inspection Readiness Guidance, Conducting TMF assessments and Creating Roadmaps for compliant TMFs. Indeed for one of our clients, an FDA inspector commented on the quality of the clinical SOPs particularly the TMF SOP reviewed as part of the Inspection. Our client passed the inspection and subsequently launched its first product in the US.
Details on www.darcy-consulting.com
Halloran Consulting Group
Halloran Consulting Group makes life science companies better at what they do. We give you the direction and expertise needed to transform your company into a more efficient organization where quality is part of the culture, not an afterthought. We stick by your side when things get tough by helping to identify and fix problems within your organization. We’ve been there. We can find a solution.
Phlexglobal are the Trial Master File (TMF) experts, and pioneers in the provision of innovative, flexible and technology-enabled TMF solutions and services.
A specialist provider of electronic Trial Master File (eTMF) solutions and other support services to the global clinical research market, we offer a unique combination of technology, quality and services that deliver a range of flexible, targeted solutions to the life science industry.
Created through the merger of INC Research and inVentiv Health, Syneos Health™ (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization. Our Quality and Compliance Consulting team assess and help clients manage risk professionally, expertly and globally. To learn more about how we are shortening the distance from lab to life® visit SyneosHealth.com.