Services
Tiffany Goethe at Bella Labae Enterprise LLC has over 19 years of combined experience in the field of clinical research. I have worked with all therapeutic areas including hematology, oncology, cardiovascular and phase 1 trials to name a few. I am a Certified Clinical Research Professional since 2006. I have been acknowledged for my compliance, recruitment, and the quality of work in the industry. I possess the knowledge and background to assist you in your research needs. I have worked in the private sectors of Mayo Clinic and Baptist Heart Specialists. My CRO experience includes ICON and PPD/ThermoScientific working with dedicated sponsors.
I can assist in utilizing eSource, CTMS, and eRegulatory software for clinical trial sites. I have reduced data errors, streamlined regulatory workflows, and accelerated timelines for industry, intramural and federal/foundation studies. This increases revenue to the sites, funding for additional personnel and new access to fast paced FDA drugs/devices.
Check out my LinkedIN profile to find out more about my experience
My Clinical Trial Consulting Services include:
New Site Start-Up
Help with the creation, modification, and implementation of site or company-specific Standard Operating Procedures (SOPs).
Consult on staffing and infrastructure to provide recommendations on current organizational concerns, training opportunities, and future partnerships.
Perform Internal Audits at your site with a focus on tracking protocol deviations, queries, and adherence to GCP, internal and sponsor SOPs, and regulatory guidelines; provide corrective and preventative action plan tools and root cause analysis as needed
Provide guidance on site selection – including preparation of detailed questionnaires – and oversight in adherence with company guidelines. Review your budget and contract against Industry sponsors for missing revenue or staff effort; perform Medicare code and coverage analysis for your study ensuring research items are paid per Medicare guidelines in your state.
Initiate and oversee research activities within private practices; conduct initial site set up.
Project Management
Identify and Contract Appropriate Vendors for project completion. Prepare/ review necessary regulatory documents including Clinical Trial Agreement (CTA) and Budget agreements.
FDA Rapid Response Team
Prepare for FDA inspections through on-site review of charts and regulatory documents as well as assist with responding to FDA 483s, including Corrective and Preventative Action Plans.
