Nitrosamine Impurities Affecting Drug-Drug Interaction Studies – Learn More

Medical Writing and Reporting

Timely, high-quality reporting when you need it most

Comprehensive Reporting and Medical Writing Services

Working with our experienced team of medical writers and scientists ensures timely delivery of high-quality reports while conforming to regulatory requirements.

With a focus on early phase clinical trials, our team of medical writers interprets and summarizes safety and pharmacodynamic (PD) data from studies involving healthy volunteers and patients, including verification of coding. Our medical writers have experience across a diverse range of therapeutic areas (including cardiovascular, respiratory, metabolic, and neurology) and are made up of recipients of B.S., M.S., and Ph.D. degrees in public health, nursing, and the medical sciences.

Working in collaboration with our pharmacokinetic scientists, biostatisticians, principal investigators and other subject matter experts, we consistently provide complete and accurate interpretation and reporting of clinical data. As early phase study designs become more complex with the incorporation of patients, PD measures, and efficacy endpoints, our medical writers’ clinical and scientific expertise allows them to extrapolate relationships across safety and PD data to ensure accurate assessment of proof-of-concept and safety during the early stages of drug development.

Our reporting team ensures that all sponsor-specific publishing requirements are efficiently executed and all appropriate submission and regulatory standards are met for fully integrated ICH-compliant clinical study reports and other scientific reports, publications or presentations as required.

Effect of OM3-CA on PK / PD and Platelet Activation

Discover the effects of OM3-CA on warfarin PK / PD and on ASA-dependent and independent platelet activation.

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