Good Clinical Practices (GCP)- Auditing Services Since 1994, ClinAudits has been in the business of conducting domestic and         international Good Clinical Practice (GCP) regulatory compliance and auditing services to the pharmaceutical, medical device, biotechnology, biologics industries, and to major academic institutions. ClinAudits is a niche provider specifically targeting your GCP auditing tasks, GCP training, SOP design, creation, revision, project management requirements and IND/NDA/PLA writing responsibilities to increase your productivity. ClinAudits does not conduct or manage clinical trials, further justifying its objectivity and independence. Services, provided on a contract basis, include: Domestic and International Clinical Research Trial Audits- established expertise in Good Clinical Practices (GCP) auditing to comply with FDA regulations, International Congress on Harmonization (ICH) Guidelines, specific company SOPs/guidelines and local governmental regulations. Contract Research Organization Audits- expertise in auditing CROs for sponsor's pre-qualification consideration and post-capability CRO study management/CRO managed studies. Central Laboratory Audits- tracking clinical trial laboratory specimens through the laboratory environment to check for compliance to GCP. Clinical Trial Supply Audits- auditing all aspects of clinical trial supplies in a clinical trial in accordance with FDA, ICH regulations/guidelines. Institutional Review Board Audits- perform audits of IRBs (commercial, academic, private and hospital) in accordance with FDA/OPHR guidelines/regulations. Audits of Final Study Reports/NDA submissions/Safety Reports/IND updates- audits of database in comparison to reports/submissions to FDA or other governmental authorities Adverse Event Reporting System Audits- process audit of AERS procedures within a country or between countries/subsidiaries. Computer Systems Validation Audits System/Process Audits, e.g., Mock- FDA audits, electronic submission audits, clinical operations and monitoring, data entry and data management, biostatistical, medical writing departments. Training of Quality Assurance and Clinical Research Personnel- customized training to your SOPs. A sample of our training services include: Review of the History and Process of Clinical Research Review of Important Clinical Research Terminology Review of the Code of Federal Regulations and FDA Information Sheets Review of the International Conference on Harmonization (ICH) Guidelines and Essential Documents Needed for Clinical Research Clinical Trial Designs Responsibilities of the Investigator Responsibilities of the Research Coordinator Responsibilities of the Sponsor IND Studies, FDA/NIH Funded Studies Monitoring Requirements and Sponsor Visits Informed Consent Process and the Informed Consent Document Recruitment and Advertisement for Patients Financial Disclosure Investigator Misconduct Test Article Accountability Adverse Events, Serious Adverse Events and IND Safety Reports Protocol Issues Medical Device Studies Data Collection, Source Documentation and CRF Design and Completion Preparation for FDA Inspections Current Trends and Findings in Clinical Research Trials- An Auditor's Perspective Good Clinical Practices (GCP)- Regulatory Affairs Services Development/review/revision of Standard Operating Procedures Development of FDA IND Safety Updates Development of NDA/PLA submissions/updates Good Clinical Practices (GCP)- Other Services Development/review/revision of Standard Operating Procedures- including clinical operations, project management, monitoring, data entry, data management, biostatistics, medical writing, quality assurance, etc. Workflow analysis (consultation) Design and implement clinical project workflow/timelines (project management) Medical writing assignments ClinAudits employs a team of consultants for larger auditing projects. The expertise of our staff encompasses a broad range of disciplines including Oncology, Infectious Diseases, Respiratory Diseases, Central Nervous System (CNS) and Dermatology in Phase I - IV clinical research. Our staff has conducted audits in Europe, Australia, Asia, Canada, Scandinavia, and the U.S. For extensive US audit projects, ClinAudits utilizes a team approach to auditing; our 30+ auditors are regionally based throughout the U.S. and Canada. For each project, our team employs strict internal quality control measures and follows internal SOPs to ensure that our work meets your high standards. We maintain close communications with our clients by using voice and electronic communications, correspondence, and, if needed, visits to client sites. We always contact the client, by telephone, within 2 working days with notification of major audit findings. Our principal competitive advantage lies in the quality of our service, responsiveness to our customer needs and dedication to providing superior, timely, cost-effective and value-added solutions to customer problems. The key to our success is the expertise of our personnel who have a thorough understanding of the drug development process. We can provide you with the resources to augment your internal staff and enhance their productivity. We guarantee strict confidentiality and adherence to the highest standards. Our consultants can report directly to a representative within your organization so that you maintain control. We will guide your projects through the audit process with a commitment to cost effective and timely results. Good Clinical Practices (GCP)- Monitoring Services Clinical Monitoring Services include: Pre-study site evaluation and setup; Ongoing data verification, test article accountability, and study file monitoring; Study-site closeout visits; In-house prospective and retrospective clinical study data collection and CRF completion