Stram Clinical Services

Stram Clinical Services is a clinical research consulting company offering a full range of research consulting services to biotech, pharmaceutical and device companies in the United States, Canada and Europe. Stram Clinical Services was started in 1995, by Donna Stram. Our goal is to provide high-quality, efficient, research and development assistance to our clients running clinical trials.

Some of our services available include:

  • Clinical data and GCP/ICH auditing
  • Corporate training program development
  • Monitoring for safety and efficacy
  • Project management
  • Foreign language translation and monitoring
  • Complete site management
  • Recruitment and training of investigational centers and personnel
  • Study coordination
  • Regulatory assurance for device and drug studies
  • Medical writing (including IND/NDA/510K submissions)
  • SOP development
  • Study drug accountability auditing
  • CRF design
  • Regulatory Assurance (device and drug)
  • Quality assurance auditing
  • CRO oversight

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.