Case Study

February 28, 2020

Advarra Consulting provides in-depth analysis of German, European, and US regulations, allowing a cancer research study to move forward.

Monitoring accrual is a key responsibility for a cancer center administrator. From answering questions for leadership to preparing for a grant submission, knowing the ins and outs of a site’s accrual metrics can ensure greater operational efficiencies center-wide.

Renewing a Cancer Center Support Grant (CCSG) is a complicated process. In order to demonstrate value to the NCI, organizations need to showcase the impact of their research in the cancer center and beyond. Collecting, analyzing, and reporting on this data is often an inefficient and labor-intensive process, requiring a large amount of dedicated staff time and resources.

With an increasing number of clinical trials conducted each year, IU’s Simon Cancer Center searched for a system that would decrease clinical staff’s time spent paying study participants and reduce inefficient workflows and associated costs.

June 11, 2019

Clear and useful guidance enables BC Diabetes to clearly demonstrate its commitment to research excellence during the AAHRPP accreditation process.

As the Case Comprehensive Cancer Center approached their recent CCSG renewal, their team recognized they needed a better system to store and analyze CCSG requirements, including grants, publications, investigators, pilots, and more.

Advarra Consulting helped a site management organization pinpoint and correct suspected fraud at two study sites. Read more about Advarra’s investigation into the misconduct in this case study.

Team members at the Barbara Ann Karmanos Cancer Institute recognized the importance of operational efficiency, and investigated ways they could gather and present operational data they had already collected to identify areas of success and opportunities for growth.

Advarra Consulting assists a small specialty biopharmaceutical company in upgrading storage of TMFs to a comprehensive electronic filing system.

Advarra Consulting assesses a mid-size device company's processes, determining the need for new and modified electronic systems and processes and proposing a CTMS.

Advarra Consulting conducts process assessments and a mock FDA inspection at a small biopharmaceutical company to support the filing of their first new drug application to the FDA.

Advarra Consulting helps implement a highly compliant clinical trial infrastructure at a mid-size device company.