35
MANAGEMENT ASSISTANCE FOR CLINICAL TRIALS OF INVESTIGATIONAL DRUGS, NAMELY, ARRANGING FOR SITES TO PERFORM CLINICAL TRIALS, ARRANGING FOR THE IMPORT, PACKAGING, SHIPPING, LABELING, AND DISTRIBUTION OF DRUGS AND OTHER INVESTIGATIONAL SUPPLIES AND EQUIPMENT TO AND FROM THE CLINICAL TRIAL SITES, ARRANGING FOR THE CENTRAL COLLECTION OF LABORATORY SPECIMENS FROM CLINICAL TRIAL SITES, MAKING ANY AND ALL FILINGS REQUIRED BY THE FOOD AND DRUG ADMINISTRATION FOR INVESTIGATIONAL NEW DRUGS AND NEW DRUG APPLICATIONS, PREPARING STATISTICAL REPORTS RESULTING FROM CLINICAL TRIALS; COOPERATIVE ADVERTISING AND MARKETING OF NEW DRUGS
37
REAL ESTATE SITE SELECTION, NAMELY, INSPECTING BUILDINGS AND OFFICES AS POTENTIAL SITES FOR HOSTING CLINICAL TRIALS
41
TRAINING CLINICAL TRIAL SITE PERSONNEL CONCERNING DRUG PROTOCOL REQUIREMENTS AND THE USE OF TESTS AND RATING SYSTEMS FOR SUCH PROTOCOL; TRAINING CLINICAL TRIAL PERSONNEL IN THE USE OF MEDICAL AND RESEARCH EQUIPMENT REQUIRED BY DRUG AND/OR DEVICE PROTOCOLS; ARRANGING MEDICAL CONFERENCES AND SYMPOSIA; PROVIDING CONTINUING MEDICAL EDUCATION TO PHYSICIANS AND OTHER HEALTH-CARE PROVIDERS AND ARRANGING AND MANAGING SPEAKERS' BUREAUS IN CONJUNCTION THEREWITH; MEDICAL MANUSCRIPT PREPARATION AND SUBMISSION; DEVELOPMENT AND PUBLICATION OF MEDICAL JOURNALS
42
TECHNICAL WRITING OF CLINICAL TRIAL REPORTS FOR OTHERS; DATABASE DEVELOPMENT SERVICES TO PROCESS DATA COLLECTED FROM CLINICAL TRIALS; PHARMACEUTICAL DRUG DEVELOPMENT SERVICES
44
PROVIDING MEDICAL MONITORING SERVICES, NAMELY REVIEW OF TRIAL DATA REPORTS FOR SAFETY PURPOSES, AND TO DETERMINE AND ASSURE COMPLIANCE WITH CLINICAL STUDY PROTOCOL REQUIREMENTS AS WELL AS COMPLIANCE WITH GOOD CLINICAL PRACTICES AND FOOD AND DRUG ADMINISTRATION AND/OR OTHER REGULATIONS GOVERNING CLINICAL TRIALS
Die Bezeichnungen wurden automatisch übersetzt. Übersetzung anzeigen