Clinical Research Consulting
The Bracane Company has been in business providing clinical research monitoring and compliance consulting since 2002. As a consulting firm, we specialize in supporting medical professionals, pharmaceutical and device companies that conduct clinical trials by providing site management, monitoring, and project management.
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 various therapeutic areas.
We have experience with the following therapeutic areas:
- Women’s Health
- Pain Management
Clinical Trial Monitoring
The Bracane Company can provide the 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 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 clinical trials. 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
Bracane Company offers staffing services for temporary, temp, temp to hire, contract to hire, project-based employment and direct hire opportunities for outpatient clinics, hospitals and government agencies. Our staffing solutions include clinical research program resourcing of clinical research associates, data managers, project managers and regulatory staff.
Health care organizations rely on quality assurance programs to develop and implement ways to ensure that mandatory standards are being met. This is needed because of the enormous amount of protocols and regulations within the field of health care.
Bracane Company works to analyze clinical research and health care requirements, develop ways for protocols to be implemented, and put a system in place to audit protocols for compliance. Organizations rely on Bracane’s quality assurance systems to identify areas of improvement and to work with their employees to ensure that regulations are properly understood and followed.
In the field of health care, noncompliant organizations face numerous risks such as legal reprimands and other consequences for disobeying state or federal health care regulations. The Bracane Company works to minimize the incidences of noncompliant organizations.
Training & Education
Bracane Company prides itself on providing regular, ongoing training for our clinical research staff. We also offer a full-range of training services to help our organization obtain the right information and hands-on training to complete your clinical trials with precision and efficiency.
Recurring Training Programs
- Basics of Clinical Research Monitoring
- Stress Management
- Diabetes Prevention Health Coach
- Seminars and Special Training Sessions
Whatever your training needs are, Bracane Company can provide it.