5 Project Management Directors

Experts from CRO, Sponsor & Site side

  • ≥ 10-20 years experience in research
  • Consulting and Advisory Services
  • Drug, biologic, device, IVD
  • Phase I - IV
  • Pilot-to-pivotal
  • Adaptive Design and Risk-based Monitoring
  • TMF audit masters for inspection-readiness
  • Protocols, Consents, Literature Reviews
  • Audit vendors
  • Cardiovascular, oncology, regenerative medicine, CNS, women's/men's health, implantable devices, vaccines, infectious diseases, GI, metabolic, immuno-oncology, respiratory, rheumatology, nephrology, rare diseases...and many others

10 Senior Clinical Research Associates

Experts from CRO, Sponsor & Site side

  • ≥ 20-30 years experience in research
  • Consulting and Advisory Services
  • Drug, biologic, device, IVD
  • Phase I - IV
  • Pilot-to-pivotal
  • Adaptive Design and Risk-based Monitoring
  • TMF audit masters for inspection-readiness
  • Site relationship management
  • SQV, SIV, IMV, RV, COV, audit-prep
  • Cardiovascular, oncology, regenerative medicine, CNS, women's/men's health, implantable devices, vaccines, infectious diseases, GI, metabolic, immuno-oncology, respiratory, rheumatology, nephrology, rare diseases...and many others
David Link, MBA

Years of experience: 30+
Chief Quality and Regulatory Officer & Founder 


Innovative and transformative leader with 30 years of progressive accomplishments in Quality Engineering, Quality Assurance, and Quality Management with market leading technology and medical device manufacturers. Proven track record of assuring customer quality satisfaction and improving profitability by identifying critical priorities, marshaling commitment, and managing cross-functional teams to successfully execute. Results-driven by solving complex problems, driving change, and fostering and enabling quality culture for learning and improvement.

3 Senior Executive Scientists

Experts from Sponsor & Government Firms

  • ≥ 15-30 years experience in life sciences
  • Consulting and Advisory Services
  • Drug, biologic, device, IVD
  • Phase I - IV
  • Pilot-to-pivotal
  • Commercialization
  • Business plans
  • ​Start-ups, Fortune 100
  • Medical Writing, Literature Reviews and Clinical Evaluation Reports (CER) per MDR
  • Protocols, Investigator Brochures
  • Grants (NASA, DoD, NIH, EU)
  • Risk Assessments
  • Regenerative medicine, CNS, women's/men's health, implantable devices, vaccines, infectious diseases, GI, metabolic, respiratory...and many others
ALETHEA WIELAND

Years of experience: 30+
President, Chief Operating Officer & Founder


Expertise in providing solutions including analyzing the intersection of healthcare innovation and policy; providing flexible clinical trial resourcing; developing sustainable corporate affairs programs and policies; training and managing resilient, high-performing clinical operations teams; mitigating risks of clinical trials; and facilitating transparent, accountable sponsor-CRO partnerships.  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

Photo Credit Jen Worley

OUR MISSION

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

Alethea

Integrity

Trust

Compliance

Transparency

Authenticity


Purpose

On-demand ICH GCP Restoration, TMF Audit, Rescue, and Compliance Team

OUR INDUSTRY EXPERTS

TEAM

CALL FOR CONSULTATION   +1.724.272.1245