Consulting
Quorum/Kinetiq Acquisition & Integration:
What You Need to Know
On March 5, 2019, Advarra announced its acquisition of Quorum Review IRB and Kinetiq, the research and technology consulting division of Quorum.
For-Cause Investigation of Potential Misconduct and/or Fraud at Two of Site Management Organization’s Locations
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.
Preparing for and Responding to an FDA Inspection
Ellen Liedel-Sargent and Robert Romanchuk outline key activities that can help prepare a research site for a positive inspection experience.
Integration Update: Leading Compliance Adherence
The Advarra team is proud to announce that all major integration activities are now complete.
ICH-GCP Guidelines and Research Conducted in the US
Learn the basics of how ICH-GCP Guidelines can impact the study ICF and how we at Advarra came to our updated policy on the topic.
What’s the Difference Between Right to Try and Expanded Access?
Let’s take a look at the basics of what each program does and does not do for patients seeking to access investigational therapies.
The EU General Data Protection Regulation: Implications for Research
Leslie Thornton and Nick Wallace provide an introduction to the GDPR and its potential application to the US-based research community.
The GDPR and Its Impact on the Clinical Research Community (Including Non-EU Researchers)
Please note that this material is provided for informational purposes only and not for the purpose of providing legal advice.
Integration Update: Recent Milestones Completed
The Advarra team has worked to fully integrate our processes and policies to provide clients with unified capabilities and support for IRB, IBC and global research quality and compliance consulting services.
Integration Update: Expanded FAQ for Advarra Merger Efforts
The following FAQ expands upon previous FAQs we’ve published and provides additional insight into the integration process.
Inventory, Quality Control and Scanning of Trial Master Files
Advarra Consulting assists a small specialty biopharmaceutical company in upgrading storage of TMFs to a comprehensive electronic filing system.
Evaluation of Clinical Systems Requirements
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.