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Clinical Research Strategies distills the complexities of research and regulatory disciplines into accessible terms and fill gaps in knowledge for life science executives, entrepreneurs, academic institutions, and investors alike, who play a pivotal role in the development and investment of a new product, to improve its chances of clearing performance hurdles toward successful commercialization or exit.

Alethea Wieland's Experience:

  • 15 years of proven clinical research strategy leadership, negotiations, operations, budgeting, publication, team-building/coaching/recruiting, and regulatory submissions in Class IIb/III medical device (CE/IDE/PMA/510k), drug (investigator-initiated INDs/CTAs), and laboratory developed test (LDT) environments.

  • Liaison and negotiations with US and international governmental bodies and regulatory officials.

  • Liaison with medical societies, independent medical advisers, principal investigators, ethics committees/institutional review boards, and investors.

  • Longstanding partnerships with medical device quality system and risk management professionals, biostatistical/bioinformatics professionals, reimbursement professionals, auditors, third party vendors, and contract research organizations.

  • Regulatory expert for FDA 21 CFR, Emergency Research 21 CFR 50.24, European MEDDEV and Essential Requirements in Medical Research, ISO 14155, HIPAA, DHHS 45 CFR Part 46, ICH Good Clinical Practices for Industry, Financial Disclosures and Conflict of Interests, Good Clinical Data Management Practices, Good Publication Practices in Medical Research, Good Laboratory Practices, Stark and Anti-Kickback Laws, Foreign Corruption Practices Act, Sunshine Law, False Claims Act, Park Doctrine, Off-label Use, EUCOMED and ADVAMED Code of Ethics, Data Use Agreement, Honest Broker, Risk Analysis and Assessment.

  • 2 years of business development in internet technology continuing medical education, performance and quality improvement, and maintenance of certification for healthcare professionals.

  • 5 years in communications directorship roles at major academic university and within a US-specialized cardiothoracic surgical association.

  • 10 years of experience with USA Federal Grants: NIH, NCI, DOD. Participation in defense at NIH.