Audits & Oversight

Audits play a crucial role in evaluating the qualifications and capabilities of outsourced functions, such as clinical vendors (e.g., Clinical Research Organizations (CROs)) or non-clinical vendors (e.g., laboratories, contract development and manufacturing organizations (CDMOs)).

They also assess critical internal processes, verify routine performance, or investigate noncompliance issues. Moreover, audits serve as robust demonstrations to health authority representatives, showcasing thorough evaluations of vendors and processes affecting data integrity and patient safety. This instills confidence in regulatory bodies, assuring them that sponsors maintain vigilant oversight throughout their clinical development program.

OUR APPROACH

Developing a Risk-Based Audit Program We collaborate with clients to create a risk-based audit program/plan tailored to their needs.

Defining Audit Scope We assist in defining the scope of each audit, ensuring comprehensive coverage.

Agenda Development We develop detailed audit agendas to guide the inspection process effectively.

Audit Scheduling & Coordination

Our team handles audit logistics, scheduling, and coordination throughout the program.

Assembly of Audit Team We assemble audit teams comprising experts with relevant expertise to ensure thorough evaluations.

Conducting Audits Whether on-site or remote, we conduct inspections, interviews, and observations as per the audit plan.

Comprehensive Reporting We prepare detailed audit reports summarizing findings, observations, and recommendations for improvement.

OUR EXPERTISE

Halloran conducts numerous Good Practice (GxP) audits of clinical trial vendors and suppliers, including Laboratories, CDMOs, CROs, clinical supply depots, and safety and pharmacovigilance entities. We also audit Institutional Review Boards (IRBs), Investigator (clinical) sites, and Trial Master Files (TMF), in addition to internal process audits. With a proven track record, we deliver successful audit programs for clients across the life science industry.

PARTNERING WITH HALLORAN

Customized Audit Program Management: We tailor audit programs to your organization's goals, objectives, and timelines, ensuring maximum efficacy.
Comprehensive Audit Support: From inception to closure, we offer dedicated support throughout the entire audit lifecycle, ensuring a seamless experience.
Client-Centric Approach: Your success is our priority. We design programs aligned with your unique challenges and objectives, delivering maximum value.

Elevate your audit processes, alleviate the burden of compliance, and experience firsthand the impact of tailored, client-focused solutions by partnering with Halloran.

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