Foundation Clinical Research (FCR) provides the following services to the pharmaceutical, biotechnology and Clinical Research Organization (CRO) industries:

• Site Identification
  FCR assists in identifying the most qualified clinical sites for participation.
  
  
  
• Execution of Confidentiality Disclosure Agreements (CDAs)
  FCR prepares, distributes and tracks the status of all site specific CDAs.  No sharing of proprietary information between the sponsor and investigative site (pertaining to the investigational drug and/or study) will occur until a fully-executed CDA is in place.
  
  
  
• Pre-study/Qualification Visits
  FCR initiates a complete assessment of each clinical research site, capabilities of staff and evaluates the sites ability to adhere to FDA regulations, Good Clinical Practices (GCPs) and the overall conduct of clinical trials.  After this visit, FCR will provide the client in a timely manner, a complete, detailed report.
  
  
  
• Collection of Core Regulatory and Financial Documents
  FCR works with clinical sites during the pre-study/qualification visit to collect all core regulatory and financial documentation required for on-time study start-up.
  
  
  
• Preparation/Distribution of Initiation Packets and completion of Site Initiation Visits
  FCR reproduces and prepares the study initiation packet along with the site regulatory binder for distribution to the clinical sites.  FCR then provides full initiation of the clinical research site which includes but is not limited to review of protocol, regulatory documents, Case Report Forms (CRFs), enrollment requirements, investigational drug and responsibilities for the conduct of the clinical trial.  After this visit, FCR will provide to the client in a timely manner, a complete, detailed report.
  
  
  
• Site Training
  FCR provides training and development to investigators and site staff in the conduct of clinical trials, specifically, the review of GCP/ICH Guidelines and FDA Code of Federal Regulations.
  
  
  
• Review and Approval of site specific Informed Consent Forms (ICFs) and assistance to clinical sites with central and local Institutional Review Board (IRB) submissions and approvals
  Through the use of sponsor specific guidelines, FCR works with clinical sites to ensure that all required ICFs contain appropriate content and language.  We also assist clinical sites with the submission/approval process with their local/central IRBs.
  
  
  
• Contract and Per Patient Budget Negotiations
  FCR provides complete and timely contract and per patient budget negotiations with the clinical research site.  These services include, but are not limited to contract language negotiation, per patient budget negotiations and tracking of the fully executed contract and budget.