President
CurrentYour Data Deserves Rock Star Treatment...... Your Data is My Passion! Please reach out if you need any clinical data management assistance. I am a results oriented hands-on data manager and proven leader with over 25 years of experience in the area of clinical data management in both CROs and Biotechs. I have worked as the only person in DM overseeing all outsourced activities, to building out CDM departments and managing them. Ensuring a successful End Game (Database Lock) starts by including an experienced Data Manager on the front end. Protocol development is the best time to start including data management and it's never too soon!Offered Services Include:~ Thorough and complete protocol review as related to CRF design and database setup~ Oversight of outsourced data management activities for Sponsors from start up through database lock~ CRF design based on CDASH and SDTM CDISC requirements and database setup~ Sponsor User Acceptance Testing including scripts (if necessary) of database entry screens and edit checks~ Data management document review and creation~ Data listing specification and review of data~ Medical Coding review of AEs, ConMeds, and MedHx~ SAE Reconciliation~ Data Transfer Agreement and Specification setup~ Vendor evaluation and qualification~ SOP review, development~ Experienced with 21CFR Part 11, CDISC, PMDA requirements, FDA regulations
