Alethea Wieland
Founder and President, Clinical Research Strategies, LLC
With more than 30 years of experience working in a variety of Sponsor, CRO and Digital/Healthcare IT companies, Alethea Wieland has numerous lessons learned from global initiatives involving research sites, sponsors, vendors, regulators, healthcare providers, and patients. Her core values and approach are to share pragmatic, risk-mitigation strategies that address the pitfalls in clinical development, trial operations and investor relations.
She is often asked to analyze the consequences of indecision, non-compliance, or taking shortcuts where life sciences companies could pay the ultimate price by struggling to manage sustainability. Her therapeutic area expertise includes oncology, immunoncology, precision medicine, digital health, critical care, nephrology, respiratory disorders, COPD/ARDs, CNS, mental health, pain, cannabis, regenerative medicine, orthopedics, women’s / reproductive health, rare disease, with special focus on Phase I-III for drugs and biologics, and Class II / III medical devices.
Clinical Research Strategies caters to start-up and mid-size life sciences organizations by providing a breath of practical and strategic solutions for many novel or first-in-class investigational products. Recent projects include assisting start-ups with clinical development and product roadmap planning; developing commercialization plans; participating in federal and international grants; submitting Pre-IND, breakthrough designation requests, Q-sub, IDE and 510(k) packages to the FDA; creating considerations for real-world evidence (RWE); providing functional service provider (FSP) teams on early and late phase clinical trials; writing EU-MDR Clinical Evaluation Reports and Literature Reviews; addressing 483 / warning letters; providing privacy and GDPR interpretation in contracts for large global clinical trials; and building or harmonizing quality management systems.
Prior to founding Clinical Research Strategies, LLC, Ms. Wieland worked for Dr. Bernard Fisher at the National Surgical Adjuvant Breast and Bowel Project (NSABP), CECity, Precision Therapeutics, ALung Technologies, and multiple CROs. Ms. Wieland serves on the executive advisory boards of eSimplify Solutions, Clinical Platform, and Root Health. She is a sought-after speaker and lecturer, and presents and teaches often at global conferences and via a variety of virtual platforms.
Ms. Wieland holds a bachelor’s degree from the University of Pittsburgh and is a life-long learner and contributor to corporate governance, regulatory policy and compliance, privacy, clinical research, digital health, interoperability, value-based care, and blockchain.