Clinical Trials: New Interventions

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.

Clinical Trials: Novel Drugs

Novel Drugs

We provide a one-stop solution from recruitment of the participating investigators, training and all subsequent administrative coordination and data collection.

Clinical Trials: Devices

Devices

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.

Clinical Trials: Treatments

Observational

Because of extensive knowledge with observational and screening studies, we know the importance of meticulous documentation for correct inferences about the effect of treatments.

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Accelerated Startuptime to market decides

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.

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Regulatoryethics is key

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.

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Project Managementensure resource efficiency

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.

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Medical Writing

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.

Why select us

CRO with Heart

We are dedicated not only to cardiovascular clinical trials.

Save Time and Money

Let our efficient and integrated structure be your advantage.

Rely on our Staff

Senior staff with experience and knowledge. Exclusively MDs, CNPs etc.

Dilligent Documentation

We know documents and we know formal requirements. We create persistence.

You say - We listen.

We are experienced, because we listen to our clients.

Europe Support

Consolidate your European activities under one hood.

Rely on your Schedule

Because we undercommit and overdeliver.

Modern Trial Processing

Paperless and agile clinical trial monitoring experience.