About the Camera
At QuantifiCare, we are proud of our project team members who come from a wide variety of backgrounds in clinical and scientific research. Specializing in pharmaceutics, biotechnology, engineering and software development, our qualified staff consist of image specialists, project managers, data managers, trainers, statisticians, etc. who are on hand to understand your trial requirements and provide you with the latest imaging techniques. As a result, your trial may require fewer subjects, completed within shorter timelines and result in on-market approval sooner.
Proven Project Management approach
In the trial set-up phase, our cross functional Project team meets with our clients study team to develop an imaging approach tailored to your study. We create documentation which includes protocol-specific image procedures, timelines, training, monitoring requirements, budgets, etc. to ensure expectations are clearly understood by all team members and by site personnel.
During the on-study and closing phases, we provide centralized, data-base tools for ‘real-time’ communication between team members and we also address issues proactively which may hinder achievement of time-sensitive deliverables. Our ‘Project Leaders’ are the key point persons between the Sponsor and Investigator sites and/or third party CRO who safeguard the smooth operation of all the imaging aspects of the trial.
Our clinical staff members are all trained in GCP and acutely aware of national regulatory guidelines. We have developed both internal SOPs and adhere to world class regulatory standards which are in accordance to FDA 21CFR Part 11 & EU guidance.