Clinical Research Consulting
We are knowledgeable of FDA regulations and understand the values that this intellectual capital brings to the industry, as well as the impact that accurate, quality clinical research results can have on the future of medication and treatment for many therapeutic areas.
Clinical Trial Monitoring
The Bracane Company can provide clinical trial monitoring for your organization. With a team of fully-trained professionals, we can manage your clinical trials from start-up through phase II-IV trials. We also offer complete training and ongoing support for new physicians and study coordinators. Whatever the need, we have the expertise and the resources to support your needs, no matter how varied or complex.
We conduct the following:
Pre-Study/Qualification Visit - We can initiate a comprehensive assessment of the clinical research site, staff capabilities, and evaluate the site's ability to comply with FDA regulations, Good Clinical Practices (GCPs) and general conduct of clinical trials
Site Initiation Visit - We can provide a review of the protocol, regulatory documents, Case Report Forms, enrollment requirements, investigation of drugs and responsibilities with regards to clinical trials
Interim Monitoring Visit - With a focus on quality, we conduct ongoing clinical monitoring throughout a clinical trial. From reviewing compliance needs to ongoing regulatory and protocol adherence, we can assist your organization through all phases of a clinical trial
Close-out Visit - When a clinical trial is ready for completion, Bracane Company is able to perform the final retrieval of all data and review your documentation to ensure accountability