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Catherine M. Lareau. Clinical trial document preparation, including clinical protocols, Investigator’s Brochures, informed consent forms. Project management and coordination with regulatory, clinical investigators, Sponsor, QC team, and statisticians. 6 years regulatory/medical writing. 10 years biomedical writing (medical education for physicians and medical students, as well as, patient health education). Preparing Compliant eCTD Submissions, 2012- Regulatory Affairs Professionals Society (RAPS). Autho...

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Catherine M. Lareau. Clinical trial document preparation, including clinical protocols, Investigator’s Brochures, informed consent forms. Project management and coordination with regulatory, clinical investigators, Sponsor, QC team, and statisticians. 6 years regulatory/medical writing. 10 years biomedical writing (medical education for physicians and medical students, as well as, patient health education). Preparing Compliant eCTD Submissions, 2012- Regulatory Affairs Professionals Society (RAPS). Autho...

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Catherine M. Lareau. Clinical trial document preparation, including clinical protocols, Investigator’s Brochures, informed consent forms. Project management and coordination with regulatory, clinical investigators, Sponsor, QC team, and statisticians. 6 years regulatory/medical writing. 10 years biomedical writing (medical education for physicians and medical students, as well as, patient health education). Preparing Compliant eCTD Submissions, 2012- Regulatory Affairs Professionals Society (RAPS). Autho...

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