EDC MADE SIMPLE

Data processing services; Providing statistical information; Business auditing services, namely, performing pre-inspection goods manufacturing practices audits and assuring that user fee monies are submitted; Biostatistics and data processing services; Performing statistical analyses; Manufacturer representatives in the field of pharmaceuticals

Providing online database for use in gathering and providing clinical trial data; Scientific research; Technical consultation and research in the medical and pharmaceutical fields; Product research and development; Service research and development, namely, medical services related to medical providers; Technical writing for others; Providing quality assurance services in the field of pharmaceuticals; Reviewing standards and practices to assure compliance with medical and pharmaceutical laws and regulations; Reviewing standards and practices to assure compliance with US Food and Drug Administration (FDA) laws and regulations; Consulting Services regarding Food and Drug law and regulation compliance, namely, preparing for and conducting meetings to discuss and negotiate development strategies, preparing and submitting documents and forms required by the FDA, preparing responses to FDA questions and warning letters, follow-up with FDA on post application submission questions, preparing for and conducting meetings with legal counsel, troubleshooting product and process issues, performing analytical methods development and validation, and designing and implementing safety and regulatory toxicology programs; Intellectual property licensing in the fields of drug, drug product, pharmaceutical and pharmaceutical products; Medical and scientific research, namely, conducting clinical trials, specifically preparing protocols, case report forms and informed consent forms; performing qualification, initiation, monitoring and closeout visits, generating investigator study files, monitor drug supply, identifying study sites and managing investigator payments, and preparing clinical sites for FDA inspection; Consultation in the fields of drug development, including working with sponsor, medical, scientific, toxicology, manufacturing and business experts to clearly delineate development requirements, evaluating available and competitive technologies; Product and process development services; Technical writing for others, specifically, integrated clinical and statistical study reports and other regulatory manuscripts; Gathering and providing patient records and patient data via a global computer information network