Expertise

Clinical: Audit Plan/Report, Briefing Books, Case Report Forms (CRFs), Clinical Development Plan (CDP), Clinical Investigative Plan (CIP), Clinical Study Report (CSR), Data Management & Validation Plan/Report, Informed Consent, Safety Monitoring Plan/Report, Site Training, Standard Operating Procedures (SOPs), Statistical Plan/Report, Study Monitoring Plan & Manual.

Medical: Abstract, Adverse Event Reports, Annual Report, Design Dossiers, Patient Narratives, Periodic Adverse Drug Phenotype Annotations, Experience Reports (PADER), Periodic Benefit-Risk Evaluation (PBRER), Periodic Safety Update Report (PSUR), Protocol, Radiograph Annotations, Safety Narratives, Serious Adverse Event Reporting, & Technical Papers.

Regulatory: Amendments, Chemistry, Manufacturing, & Controls (CMC), Device History File (DHF), Investigative Device Application (IDE), Investigative New Drug Application (IND), Investigator Brochure (IB), Labeling, Marketing Authorization Application (MAA), New Drug Application (NDA) Summaries, Premarket Approval (PMA), Premarket Notification (510(k), Response to Health Authorities, & Trial Master File (TMF).

Business: Analytical Plans/Reports, Assembly Instructions, Briefing, Budget, Business Plan, Communications Plan, Confidential Disclosure Agreement, Cost Analysis, DMAIC/A3, Financial Forecast, Flowchart, Gantt Chart, Grant, License, Meeting Minutes, MS Project Schedule, Policy Manual, Presentation, Process Manual, Project Charter, Proposal, Quality Policy, Reports of Analysis, Request for Proposals, Risk Mitigation Plan, Specifications, Statement of Work, Status Dashboard, Summary, Timelines, Trackwise Plan, User Manual, Validation & Verification Plans, & Websites.