Clinical Research Services

We provide expert staffing and program management to support all aspects of preclinical and clinical research including project management, program management, regulatory, data management, clinical monitoring, quality management, human subjects protection and clinical trials with human research subjects. As a result of decades of experience supporting clinical and social behavioral research and our constant drive to produce results through compliant, ethically conducted research we can offer professional services that will exceed expectations.

Our CRAs bring strong monitoring and clinical experience to our customers with most of their experience in key therapeutic and specialty areas.

In addition, each member is fully trained in FDA regulations, ICH guidelines, and GCP/SOP compliance. Our teams will help you get faster, more efficient

investigator site support and monitoring.

As a result, our monitors thoroughly understand the many complexities associated with trials in the therapeutic area in which they primarily practice, provide quality reports, performance feedback, study

training and technical support, data query resolution, source document review, and site management for all types of visits.

Medical monitoring ensures that investigators are:

• Appropriately selected
• Trained to complete the proposed protocol-driven research
• Able to adhere to proper patient/subject protection standards
• Recruiting eligible patients
• Compliant with protocol and required regulatory requirements and guidelines

Clinical Research Services provides regulatory

services to facilitate all stages (Pre-clinical - IV) of drug development. Our ability to assist sponsors obtain regulatory approvals is supported by a deep understanding of, and experience with FDA regulations, ICH-GCP guidelines and facilitating IND Support Services. We provide complete study management and/or as customized services.

Services:

• Regulatory dossier compilation
• Regulatory approvals for pre-clinical – phase IV studies
• Safety reporting
• Product registration for marketing approval