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.
Complion’s mission is to reinvent site regulatory and document management by eliminating human error and redundant work to achieve maximum efficiency and compliance. We are the first and are the largest eRegulatory platform built for sites, health systems, academic medical centers, and cancer centers.
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.
inSeption’s insistence upon securing the “right” people to integrate into a true partnership alliance with its clients eliminates the vulnerability so often felt by operational leaders faced with evaluating traditional outsourcing options. inSeption’s core competency of identifying and securing the most experienced and proficient professionals builds the crucial foundation of a successful drug development program. Actively collaborating with its clients to custom design, hand select and assemble high-performing project teams empowers inSeption to tailor its services specifically to meet the needs of their programs. The inSeption model provides increased control, full transparency of project deliverables and timelines, and significant operational and cost efficiencies.
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.
Syneos Health Consulting is a management consulting firm specializing in the biopharmaceutical industry and part of Syneos Health, the only fully integrated biopharmaceutical solutions organization. We provide services across a comprehensive range of key areas, including portfolio strategy, brand commercialization, and commercial model strategy/planning; medical and regulatory affairs; risk and program management; and pricing, market access, and HEOR. Recognized by Forbes magazine as one of America’s Best Management Consulting Firms, we combine industry focus and depth of functional expertise with strong scientific and market knowledge to tackle highly complex business and market challenges and develop actionable strategies for our clients. For more information, visit https://www.syneoshealth.com/solutions/consulting
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.