BCRS Services - How do we do it?

BCRS provides a complete range of services relevant to Phase I clinical and bioanalytical research. Whether working with pharmaceutical / biotechnology sponsors or partnering with Contract Research Organizations, we are fully capable of providing any combination of these services for our clients:

Site Qualification and Study Placement

Selecting a CRO with the expertise and experience that matches your needs can be a complex task. We will identify a site (or sites) that have the capabilities your program requires and assist with the placement of the study to ensure requirements are met for both performance and timing. Because we have conducted hundreds of studies, we know what to look for and the questions to ask before committing your project to a facility. Selecting the right site for your project can help reduce the risk to your study.

In-Life Monitoring

We provide on-site prospective review of study documentation as well as in-life monitoring to ensure compliance with the protocol, SOPs, and regulatory requirements. Status reports and audit reports are provided on a routine basis.

Third Party Auditing of Study Data for Regulatory Compliance

Ensuring the data produced by a CRO will meet FDA requirements is a major component of our business. Whether dealing with Phase I clinical data or bioanalytical data, we are highly experienced and fully capable of an unbiased review. Securing the quality and integrity of the study data before it leaves the CRO can facilitate the FDA approval process.

GCP/GLP Compliance

Government regulations of clinical and bioanalytical research are comprehensive and strictly enforced. We audit study data and relevant SOPs to ensure applicable Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) regulations have been followed. Ensuring the quality and integrity of your data is the cornerstone for a successful review and approval of your application.

Facility Inspections

We conduct Phase I clinical and bioanalytical facility inspections with an emphasis on the suitability of the facility for conducting studies. We review training and staff qualifications, SOPs, computer systems and validations, regulatory histories, equipment maintenance records, and all other areas with an impact on the ability of the facility to meet FDA expectations.

Simulated FDA Inspections

Knowing what the FDA expects and providing the information they require in an organized manner greatly facilitates the audit process. In order to assess the CRO’s preparation and to determine if additional data are required, we conduct FDA-style audits of the CRO and your study data. We will provide our assessment of the facility and the data along with our recommendations.

Our years of experience dealing with the FDA enables us to fully represent clients during study audits, assist in responding appropriately to FDA deficiencies, and formulate corrective actions. We provide this service to CROs in the United States and abroad, ensuring they are compliant with FDA requirements.

SOP Development

Standard Operating Procedures (SOPs) are the structural backbone of any federally regulated industry. We assist in the development of SOPs for Phase I clinical and bioanalytical research to ensure FDA expectations for process control are met. We also evaluate existing SOPs for content, consistency, and compliance.

GCP/GLP Training

Developing the technical skills and expertise of staff is a time consuming effort and can prevent managers and supervisors from their primary tasks. We provide both general and customized training programs to meet the needs of your staff and organization.

Technical and Management Consulting to Contract Research Organizations (CROs)

With extensive experience in the CRO industry, we provide management consultation on all aspects of Phase I clinical and bioanalytical research. We can evaluate your business or operational structure to ensure your organization is functioning at its maximum efficiency.

Learn more about BCRS > Learn about our team >
  • Site Qualification and Study Placement
  • In-Life Monitoring
  • Third Party Auditing of Study Data for Regulatory Compliance
  • GCP/GLP Compliance
  • Facility Inspections
  • Simulated FDA Inspections
  • SOP Development
  • GCP/GLP Training
  • Technical and Management Consulting to Contract Research Organizations (CROs)