Sponsors – 8th Clinical Trials Inspection Readiness Summit
To learn more about sponsorship and exhibition opportunities at our 8th Clinical Trials Inspection Readiness Summit, ExL’s inspection preparation and compliance conference, please contact Chris Summa, Business Development Manager, at 917-932-0432 or firstname.lastname@example.org.
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
Just in Time GCP
Just in Time GCP supports small and mid-size pharma companies and CROs in managing their Trial Master Files. Whether you are anticipating a regulatory inspection, need resourcing for routine quality oversight of your TMFs or are planning the implementation of a TMF system, Just in Time GCP can support you. We have extensive industry experience in clinical operations and truly understand the complexities of trial management and drug development. We partner with your organization in ensuring that your TMFs are inspection-ready. We take the stress out of TMF management.
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.