Kim Boericke

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strategic consulting safety management data management biostatistics statistical programming project management medical writing regulatory submissions adaptive clinical trial design site monitoring regulatory consulting clinical trial patient recruitment clinical trial data standardization clinicl trial design clinical trial management us regulatory agent pharmacovigilance marketing applications support ind support regulatory publishing biologic gene therapy fullservice cro oncology clinical trials research services clinical trials cro biologics cell & gene therapies vaccine trials rare diseases pediatric trials decentralized trials rescue trials clinical trial planning clinical trial conduct regulatory submission natural history studies regulatory affairs medical affairs biometrics data monitoring committees patient recruitment patient retention clinical trial safety full-service solutions adaptive designs chemistry manufacturing controls agency meetings clinical operations monitoring services site management fda compliance marketing applications advanced therapy therapeutic areas oncology neurology infectious diseases endocrine diseases immunology covid-19 research clinical trial expertise data integrity scientific consultancy study design therapeutic development clinical research organization full-service cro regulatory strategy biopharmaceutical consulting patient safety data analysis hematology metabolic disorders innovative therapies patient-centric design global compliance market access drug development commercialization support scientific excellence operational efficiency client collaboration complex therapies adaptive trial design post-marketing surveillance marketing authorization applications new drug applications cross-border trials therapeutic specialties industry expertise client satisfaction flexible work environment professional growth competitive landscape market challenges economic resilience b2b management consulting productivity health care health wellness & fitness hospital & health care data analytics