Experience & Publications

Work History

Stram Clinical Services, Dunstable, MA

Consultant, President, 6/95 – Present
Since June of 1995, Donna Stram has operated a pharmaceutical research consulting
company, acting as both Director and Principal Consultant, on diverse
projects. She has extensive experience auditing and monitoring clinical
trials from initiation through closeout, performing project management,
recruiting and training novice research personnel, building a clinical
department, performing complete site management of research centers,
acting as the Study Coordinator for large centers, writing and filing
FDA submissions, supervising CRO personnel, auditing and assuring
device and drug study regulatory compliance.

ImmunoGen, Inc., Cambridge, MA

Clinical Research Associate II, 12/93-6/95

    • Monitored safety and efficacy of antibody-linked anti-neoplastic toxins.
    • Designed case report forms for HIV-associated non-Hodgkin’s lymphoma studies.
    • Co-authored a publication summarizing Phase II study results for an HIV-associated non-Hodgkin’s lymphoma study.
    • Prepared study-relevant annual report sections.
    • Developed SOPs for Clinical Operations.
    • National Medical Research Corporation, Hartford, CT
    • Senior Clinical Research Associate, 2/93-12/93
    • Monitored safety and efficacy of recombinant thrombolytic agent.
    • Directed the activities of six CRAs on the above project.
    • Made formal bi-weekly progress reports to the corporate sponsor.

Symtonic S.A., Boston, MA, Renens, Switzerland and New York City, NY

Clinical Trials Administrator, 3/90-2/93

  • Monitored safety and efficacy of anxiolytic and somnogenic agents.
  • Designed Case Report Forms.
  • Reviewed and analyzed clinical data.
  • Managed Annual Budget

National Medical Research Corporation, Hartford, CT

Senior Clinical Research Associate, 2/93-12/93

  • Monitored safety and efficacy of recombinant thrombolytic agent, audited clinical and regulatory data
  • Directed the activities of six CRAs on the above project.
  • Made formal bi-weekly progress reports to the corporate sponsor.

Publications

Scadden DT, Doweiko J, Bernstein Z, Schenkein D, Luskey B, Stram D, Esseltine D, Levine AM. Combined immunotoxin and chemotherapy for initial treatment of AIDS lymphoma. Abstract and poster presented at the 36th Annual Meeting and Exposition of the American Society of Hematology, 1994.