Clinical Research

 
An Eye For Detail Consultancy, LLC
Clinical project management services tailored to the client’s needs.

 
Services Include:
 
·       Clinical project management (Phase I – IV)
·       Management of CRAs (in-house and contract) and CROs
·       Study site selection
·       Site Monitoring (including Site Initiations and Close-outs)
·       Budget development and negotiation
·       Writing of protocols, informed consents, study manuals
·       CRF  and source document design
·       Organization of Investigator Meetings, Scientific Advisory Board Meetings
·       Over 20 years of experience in the Biopharmaceutical industry as well as in academic
        institutions and a clinical research organization.
·       Global Phase I – Phase IV trials in therapeutic areas such as Gout, Orphan Diseases
        (Metachromatic Leukodystrophy, Globoid Cell Leukodystrophy, San Filippo and Hunter’s
        disease), Oncology (CLL, glioma and Multiple Myeloma), Cardiovascular Disease, Gene
        Therapy, Scleroderma, Ulcerative Colitis and Diabetes.
 
Currently based in the San Diego area, but lived and worked in Europe for several years and developed international experience in Clinical Affairs. She has a thorough knowledge of ICH-GCP. Also experienced with electronic data capture (RAVE and Inform).
 
Contact Information:
Susan Szambelan
Director and Founder
Susan.szambelan@gmail.com
+1-508-404-3454 (PST zone)