Sponsors – 9th Clinical Quality Oversight Forum

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 abutler@questex.com.


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.

Website: http://www.cluepoints.com/

DArcy Consulting

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

Website: http://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.

Website: http://www.hallorancg.com


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.

Website: http://www.phlexglobal.com

Syneos Health Communications

Syneos Health Communications (previously inVentiv Health Communications) is the only healthcare communications network that is part of a company on the frontlines of healthcare, with a clear view into the everyday complexities of life and health. As part of Syneos HealthTM, our advertising, branding, public relations, managed markets and medical communications agencies are engaged in every point of influence in health, providing real-world insight into markets and audiences. We work in scalable, collaborative teams that partner across disciplines and geographies to deliver integrated communications strategies that accelerate brand performance. We create ideas that will work in the real world because they were built there.

Website: https://www.syneoshealthcommunications.com/


Since 2003, YourEncore has been delivering premier strategic and technical advisory services and solutions to the Life Sciences and Consumer Goods industries. Our subject matter experts are experienced industry practitioners – alumni from some of the most respected companies in the world – offering their extensive hands-on experience in solving the same challenges our clients face today, to help them outthink, outpace, and outperform the competition. Our mission is to enable a world of experience to make a difference in the world.

Website: https://www.yourencore.com/