Treatments
Experimental treatments, new approaches to surgery or radiation therapy require different CT design and protocol. We have specialists with field experience in this area.
Experimental treatments, new approaches to surgery or radiation therapy require different CT design and protocol. We have specialists with field experience in this area.
We provide a one-stop solution from recruitment of the participating investigators, training and all subsequent administrative coordination and data collection.
Because we know the specifics of device clinical trials and regulatories of AE and SAE handling in these studies, you can rely on our expertise for this CT domain.
Because of extensive knowledge with observational and screening studies, we know the importance of meticulous documentation for correct inferences about the effect of treatments.
Our reputation for rapid startups is based on our ability to evaluate, identify and select those sites most capable of rapidly enrolling high-quality patients. Our fast, study-startup process enables us to get sites up and running faster so we can start enrolling patients sooner.
Because we know the markets we are present in, we enroll not only on time, but frequently ahead of schedule and often with fewer sites than our competitors.
We write, review and compile electronic and paper submissions for all aspects of the IND process through to the NDA and annual reports.
We conduct critical reviews of key technical documents aiming to ensure completeness, scientific accuracy, regulatory compliance, consistency with other key documents and ease of review.
We deliver on our promise to meet milestones and use real-time metrics to demonstrate our success. A single point of contact is provided to you as well as to our vendors and project support teams
We know our clinical sites intimately, so we manage to the highest quality and accord significant adverse events the highest attention.
Our medical writing teams work in close collaboration to provide a variety of services, including briefing packages and supplements for investigational new drug (IND) and investigational device exemption (IDE) submissions.
Clinical protocols, clinical study reports (CSR), integrated safety/efficacy summaries (ISS/IES) and literature reviews are natural ingredients of the service packages offered.
We are dedicated not only to cardiovascular clinical trials.
Let our efficient and integrated structure be your advantage.
Senior staff with experience and knowledge. Exclusively MDs, CNPs etc.
We know documents and we know formal requirements. We create persistence.
We are experienced, because we listen to our clients.
Consolidate your European activities under one hood.
Because we undercommit and overdeliver.
Paperless and agile clinical trial monitoring experience.