Alethea Wieland – President, Chief Operating Officer & Founder, Clinical Research Strategies


Ms. Wieland is founder and president of Clinical Research Strategies, LLC, (“CRS”), a specialty CRO and executive management consulting firm that fits-for-purpose veteran life sciences executives, attorneys, regulatory scientists and strategists, clinical operations, project management, quality assurance engineers, and sales and marketing teams to take on the biggest challenges for start-up, mid-sized, and Top-50 life sciences companies, many of whom are facing complex regulatory reform or are developing novel, first-in-class drugs, biologics, diagnostics and medical devices, or software as a medical device (SaMD). Service areas of her firm include clinical trials, Functional Service Provider (FSP) models, selection and management of CROs, regulatory compliance strategy and submissions, QMS, EU MDR and GDPR, rescue trials, TMF, risk mitigation and remediation, training high-performing teams, staffing solutions, and decentralized trials.

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