Medical, Regulatory & Scientific Writing
Pharsight has medical writing capabilities to support protocol writing, individual study reports, and PK sections of integrated reports for regulatory submission. Medical writing deliverables include documents prepared in accordance with FDA, EMA, Health Canada, ICH, and CONSORT guidelines as well as established in-house QC/QA processes and SOPs.
We have experience using a variety of customized reporting templates and client-specific style guides/standard operating procedures.
Protocol Study Design Outline (SDO): in collaboration with biostats group, based on regulatory (FDA, Health Canada, EMA) guidance requirements for clinical trials and specific drugs/therapeutic areas.
- Overall design factors to meet study objectives
- Proposed PK/PD/safety endpoints
- Statistical approaches to measure primary and secondary endpoints
- Sample size calculations
- PK sampling
- Analytes to be measured
Statistical Analysis Plan (SAP): in collaboration with the biostats group, as needed; in-house or customized templates.
Critical Review of Sponsor Study Documents: protocols, SAPs, regulatory documents.
Pre-clinical GLP Study Reports: Includes TK, allometric, IVIVC analysis and reporting.
Noncompartmental, Compartmental, and Population PK/PD Analyses and Reporting
ICHE3 Clinical Study Report (CSR): complete report and appendices including efficacy and safety, in-depth review from the biostats group of CSR methodology and results sections. Experience in Phase I and Phase II reporting, including:
- ADME Mass Balance Studies
- Absolute/Relative Bioavailability
- Single Ascending Dose (SAD)
- Multiple Ascending Dose (MAD)
- Food Effect Studies
- Drug-Drug Interaction Studies
- Effect of Age and Gender, Hepatic and Renal Impairment, and Genetic Polymorphisms of Drug Metabolizing Enzymes on PK/PD.
Abbreviated PK/PD Reports and Synopses
Coding of Adverse Events Using MEDRA
Patient Narratives
Pre-IND and NDA Briefing Packages
Electronic Common Technical Documents (eCTD): Modules 2.4, 2.5, 2.6, and 2.7.
Abstracts, Manuscripts, Posters