Performance, Excellence, & Efficiency in Research
With over 30 years of experience in the conduct, administration, review, and compliance oversight of research, George Gasparis launched The PEER Consulting Group ("PEER") in 2013. The consulting group consists of three divisions: 1) Associates for Clinical Trials Management (ACT Management), 2) Associates for Research Compliance (ARC), and 3) Associates for IRB/HRPP Solutions (AIS).
PEER currently has nearly 70 expert consultants in the three divisions. Our areas of expertise include: 1) monitoring of research on behalf of Sponsors, CROs, or Sponsor-Investigators; 2) management of research studies in a manner that ensures scientific objectives and compliance with regulatory requirements; 3) ethical and regulatory review of human subjects research; 4) management of compliance oversight activities, with specialization in root-cause analysis and development of appropriate corrective action plans; and 5) consultation for Research Administration, including Conflicts of Interest (COI) Committees, HIPAA/Privacy Boards, grants management/sponsored programs, research billing, Embryonic Stem Cell Research Oversight (ESCRO) Committees, and radiation/safety/Radioactive Drug Research Committees (RDRCs).
PEER also has extensive experience in reporting of compliance cases to federal regulatory agencies and resolution of regulatory concerns in a manner that maintains public trust of an institution's research enterprise or an investigator's professional reputation.
ACT Management provides services for the conduct, management, and oversight of clinical trials. ACT Management works closely with the Sponsor, CRO, or Sponsor-Investigator (SI) to ensure that all performance sites understand the study's goals and conduct the study in accordance with FDA regulations/GCP Guidance. Additionally, ACT Management can help resolve challenges that sites face to meet timelines. We also work closely with the data and/or statistical coordinating centers to ensure that data and endpoints are collected in compliance with the protocol.
ARC provides consultation for investigators conducting research. The consultation aims to promote excellence by the research team, not only by ensuring compliance with federal regulations and guidance, but also by enhancing capture of data and endpoints required by a given protocol. ARC meets its objectives by conducting evaluations, monitoring, or audits of studies. ARC also provides expert guidance and preparation for FDA audits or responses to FDA 483 reports or FDA warning letters.
AIS provides consultation for human research protection programs (HRPPs), institutional review boards (IRBs), or ethics committees responsible for the review of human subjects research. Institutions can improve the integration and effectiveness of its HRPPs through the consultation services provided by AIS. AIS also promotes excellence of an IRB/ethics committee by enhancing the quality and efficiency of its reviews. AIS provides either targeted or comprehensive evaluations of all components of an HRPP and/or IRB/ethics committee.