Drug development experts for FDA and EMA regulatory submissions.
We gather, summarize, code, analyze, write, and report, to quickly reach regulatory milestones and achieve drug approval.
Regulatory and Scientific Writing
- Clinical Trial Protocols
- Investigator Brochures
- Drug Applications (IND/NDA/aNDA/sNDA)
- Orphan Drug Applications (ODA)
- Meeting Requests
- Meeting Request Packets
- Statistical Analysis Plans (SAP)
- Clinical Study Reports (CSR)
- Pharmacy Manuals
Statistics
- Statistics Services
- Study Design
- Protocol Development
- Statistical Analysis Plans (SAPs)
- Analysis Dataset Development
- Data Cleaning
- Statistical Tables
- Data Listings
- Figures
- TLFs
- Randomization
- Sample Size Estimates
- Reporting for Data Review Committees
- Drug Safety Monitoring Boards
- Institutional Review Boards
- Formulation Screening
- Formulation Equivalence
Pharmacokinetics
- Pharmacokinetic Data Analysis
- Pharmacodynamics
- Bioequivalence
- Clinical Equivalence
- Simulations
- Parameter Comparisons
- Figures
- Report Summaries
- Sample Size Estimates
Contact
For a Pop-Up Consultation please contact us at:
rmacarthur@researchpharmacy.com
Calendly
https://calendly.com/rmacarthur-researchpharmacy
About
For over 40 years, Robert has been actively involved in commercial drug development and manufacturing, clinical research, and hospital pharmacy practice. His diverse work experience encompasses biotech startups, orphan drug startups, large pharmaceutical companies, commercial phase 1 units, GMP drug manufacturers, and academia.
For more information visit my LinkedIn Profile:
https://www.linkedin.com/in/rbmacarthur