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Regulatory Affairs/Clinical Trial Support Services

ATC has the expertise on staff to help our clients meet regulatory requirements for conducting clinical research and for drug and device development at every stage. Our staff includes experienced regulatory affairs scientists, medical writers, clinical trial monitors and auditors, human subjects protection scientists, statisticians, product managers, and specialists in health informatics, IRBs, and quality assurance. We assist our clients with writing and submitting documents such as NDAs, INDs, IDEs, Investigator Brochures, protocols, consent forms, annual reports, continuing reviews, SOPs, case report forms, and final clinical study reports.

ATC manages a branch for Regulated Activities and Facilitated Training. We provide trainings from one to five days in length on a variety of topics, including current Good Clinical Practices (cGCP), current Good Manufacturing Practices (cGMP), current Good Laboratory Practices (cGLP), Human Subjects Protection, CAPA, and other topics related to clinical research. These trainings are offered in the U.S. and internationally, and have been attended by many Army personnel, civilians who support the Army’s clinical studies, and personnel from other regulatory agencies and private industry. We also have training support such as PowerPoint development and suggestions for icebreakers and activities to keep attendees alert, engaged, and free from boredom. ATC has transcription services to include recording and producing meeting minutes in multiple formats.