JUST IN TIME GCP

Business consulting and process assessment services in the nature of providing information management services in the field of document management in clinical research trials and clinical trial result submission; Business consulting in the field of clinical research trials; Clinical research compliance consulting, namely, tracking and assessing clinical research regulatory compliance for business purposes; Business consulting and management in the field of clinical trials, namely, clinical data and regulatory submission management on behalf of pharmaceutical, biopharmaceutical, biotechnology and medical device companies to assist in clinical research, clinical trials and applications for drug approval; Providing independent review of clinical trials for business purposes; Data-processing and creation and management of documents, namely, services comprising the review and analysis of business information comprised of written communications and information in documents and management of business records in the nature of documents, for use in connection with clinical trial master files in relation to good clinical practices, all for business purposes

Educational services, namely, classes, workshops, seminars and training programs in the field of clinical trial quality management systems, clinical trial auditing, and good clinical practice standards and procedures

Quality management services, namely, quality evaluation and analysis, quality assurance, and quality control, in the fields of pharmaceutical, biopharmaceutical, biotechnology and medical device clinical research and testing; Quality audit services in the nature of evaluation and analysis, and quality assurance consultancy in the field of clinical trial and clinical research quality control for others; Technical inspection services, namely, inspection of clinical data, clinical procedure, clinical process, clinical database, and clinical reports for others, for quality control purposes; Preparation of reports in relation to clinical trials and clinical research and preparation of reports on management of scientific research projects, clinical research projects, clinical trials, and clinical trial audits, pharmaceutical product evaluations, drug development and pharmaceutical product evaluations, all of the foregoing for quality control purposes

Consulting in the field of governmental regulatory compliance inspection preparedness, namely, regulatory compliance assessment and auditing services in the pharmaceutical, biopharmaceutical, biotechnology and medical device field, for regulatory compliance purposes; Consulting services in the field of pharmaceutical, biopharmaceutical, biotechnology and medical device clinical trial regulatory compliance in the fields of creating case report forms for clinical trials, generating compliance and performance reports, managing clinical data, monitoring and tracking clinical trial audit activities, reviewing and auditing clinical trial data, and accessing clinical trial standard setting resources, all for regulatory compliance purposes