Medical and Scientific Writing

AAIPharma provides medical and scientific writing support at all stages of the development life cycle. Our clinical and scientific documents are produced by a medical writer working in close collaboration with input from other experts (medical, scientific, pharmacokinetic and regulatory) as appropriate. The team works closely to ensure conformity to appropriate regulatory requirements and the consistency, accuracy, presentation and medical/scientific quality of the document contents and statistical analyses.

Documents are drafted by our medical writers using the Sponsor's model or an in-house template adapted to the specifics of the individual study. All medical writers have a PhD or MSc in life sciences and the team includes native English speakers.

The medical writer is responsible for preparing and validating the document's ICH compliance, contents and format. CSR data validation (100%) is performed against the final statistical analysis output. Draft documents are sent to the Sponsor for review and comments are integrated before final approval.

The medical reviewer is responsible for protocol study design, designation of critical data management parameters, design of CSR data tables, medically-driven interpretation of the statistical data (including requesting additional statistical analyses where appropriate), performing literature reviews, providing medical background for protocols and CSRs, SAE narratives (if required) and review of all study-related documents.

Our statisticians provide protocol input for definition of study objectives and endpoints, study design, sample size calculation, randomization and statistical analysis sections. The statistician works closely with both the medical writer and medical reviewer for the preparation, review and interpretation of the statistical analyses.

The team places strong emphasis on the development of CSRs beyond standardized report writing. A maximum of medically relevant information is extracted from the study, and each report is specific to the drug, the indication and the current development context.