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NO OBLIGATION CONSULTATION   +1.724.272.1245

CRS Lin

 AWARDS

 2017 Governor Tom Wolf Recognition in PA Life Sciences

 2017 Women in Bio P.O.W.E.R. Award

 2017 Pittsburgh City Council Recognition in Life Sciences


 MEMBERSHIPS / ADVISORY ROLES

  • Women-in-Bio, Pittsburgh Chapter, Mentorship program
  • Advisor-Partner to Crucial Data Solutions, Zircon Technologies,  PhenoMx, Clinical Platform, TAB Clinical Trials (US-based CRO)
  • Pittsburgh Technology Council 
  • German American Chamber of Commerce

Specialties: 

· FDA Regulatory Negotiations/Submissions · Clinical Research Operations
· Corporate Compliance · CRO Selection and Management 
· Budgeting and Forecasting · Requirements Analysis · Legal Analysis
· US Transfer Pricing and At Arms' Length Agreements · International Business
· Grant, RFP and Proposal Writing · Coaching/Training · Strategic Planning 
· Process/Quality Improvements · Risk Analysis/Management  
· Client/Investor Relations · Gap Analysis · IT Healthcare Technology 
· Team Leadership/Development · Consensus-Building · Fiscal Discipline
· Contract Review and Negotiation · Human Resource Programs 
​· EHR-to-EDC Interoperability · Rescue Trials · IND Regulatory Agent

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About

OUR MISSION

TO IMPROVE YOUR BUSINESS' PERFORMANCE AND PROVIDE A SUCCESSFUL CLINICAL RESEARCH DEVELOPMENT PLAN AND STRATEGY.

Alethea

“Alethea demonstrated rapid assimilation in our clinical development planning and was instrumental in showing us risks we never thought of evaluating. Her insights are really invaluable and we want to continue our collaboration to bring our PARP inhibitors into the US for trials!”


H. J. 

PRESIDENT AND FOUNDER, EU IMAGING COMPANY

ALETHEA WIELAND

Years of experience: 25+
President & Founder | Management Consultant


  • CEO, President, Secretary, Treasurer Board of Directors
  • ​Foreign direct investment (FDI) relationship building with EU Sponsors and parent company, Chinese VCs and Chinese drug executives
  • Expert partners within life science industry for small and large projects
  • US transfer pricing regulations and at arms' length agreements
  • Navigation of US FDA regulatory landscape: strategy, face-to-face negotiations, pre-Subs, IND, IDE, 510(k), DeNovo submissions, US Regulatory Agent
  • Indications: Oncology, Precision Medicine, Regenerative Medicine, CNS, Orthopedics, Surgery, Critical Care, Respiratory, Women's Health, Nephrology, LDTs, biomarkers, and assays
  • Submittals and regulatory strategist for international regulatory authorities: EMA, UK MHRA/NICE, Australian TGA, Health Canada HPFB, German BfArM, French Ministry of Health, Korean MFDS, and Notified Bodies 
  • 20+ years of international clinical research operations, trial design and execution, quality assurance, inspection-readiness, and CRO due diligence/selection/management
  • 18 years of corporate compliance in life sciences and federally-funded programs (NIH, DoD) 
  • 16 years of publications/medical advisory/endpoints committee/data safety/adjudication committee management, business development, client relationships, and board interactions 
  • 10 years of strategic planning, risk management, and change management 
  • 10 years of process and continuous quality improvement implementation and training 
  • 8 years of influence and human resource management in positive corporate culture that prioritizes employee engagement, development and advancement 
  • Fiscal discipline and pragmatic forecasting that reduces the squandering of resources or unexpected spend 
  • A lifetime of true grit, creativity, innovation, collaboration, accountability, flexibility, and win/lose early mindset