WHY CHOOSE IBA?
Our regulatory compliance project managers directly support principal investigator duties in planning, developing, monitoring, collecting, and storing data as it pertains to approved research studies. We understand the requirement to manage multisite activities as they pertain to research studies to include protocol development and project execution. We appreciate the dynamics of developing and coordinating approval of clinical protocols with IRBs, HRPOs, and ORPs including requirements for updating patient administration and privacy systems.
We coordinate with multiple institutional review boards (IRBs) during the production, review, and submission of study documents, including protocols, questionnaires, advertisement materials, and informational presentations. We also provide extensive training and direct project opportunities to research the statistical methods used in clinical research studies and to ensure we are monitoring regulatory compliance for projects. This training approach, in addition to required Department of Defense and federal government training, allows us to continue our solid relationships with the Office of Research Protections (ORP) and HRPO for clinical research studies.
WHAT WE OFFER
We continue to identify methods to streamline onboarding of study participants, leveraging our prior experience consenting patients onsite at military treatment facilities. We are intimately familiar with protecting PHI and PII, and managing study data storage in accordance with approved clinical protocols. Our team members include certified clinical research coordinators and licensed registered nurses. Our staff members have direct military background, have extensive experience supporting past clinical research studies, and are intimately familiar with electronic health record (EHR) systems, such as AHLTA, CHSC, AWCTS, and MHS Genesis.
Our regulatory project managers are experienced in wide ranging areas of expertise, and are key resources for our collaborators and stakeholders. Their analytical skills and vast knowledge enable us to identify evolving trends, protocols and policies for clinically significant data and information in an immensely dynamic industry.