RESEARCH PRACTICES

RESEARCH PRACTICES AT SEQIRUS

Research and development is vital to advancing solutions to disease and global health challenges. Healthcare professionals and the public rely on the safety and efficacy of vaccines and pharmaceutical products, and that these products are proven through clinical trials and developed in a regulated environment.

At Seqirus, we are committed to carrying out R&D in an ethical and transparent way as well as in accordance with government regulations and industry codes for good practice.

Clinical Trials

At Seqirus, clinical trials are one of the most important steps in developing new influenza vaccines in order to safeguard the public.

A clinical trial is a research study in which people volunteer to receive a new vaccine and to be observed for its effects in terms of its safety and effectiveness. Before a trial can begin, the vaccine is first tested extensively in the laboratory and where necessary, in animals. Clinical trials are carefully supervised, monitored, and documented. The applicable regulatory authority must grant approval to conduct testing in humans. Trials are overseen by independent review or ethics committees.

Clinical Trial Transparency

As part of the CSL Group, Seqirus is committed to ensuring the transparency and public accessibility of information related to our global clinical research activities. This information enhances scientific exchange, and helps people to make informed decisions about potential influenza vaccine options as well as potential participation in clinical trials. Seqirus makes every effort to comply with national and international standards relevant to clinical trial disclosure and data.

To this end, we are committed to:

The prospective registration on a publicly available trial registry of all Seqirus-sponsored clinical trials and applicable observational/non-interventional studies (NIS); and

The reporting of results of completed Seqirus-sponsored clinical trials and applicable observational studies/NIS on a results database or equivalent website, according to regulatory requirements. Results are made publically available, regardless of the outcome.

Conducting Clinical Trials

Seqirus has a Quality Management System that consists of an independent Quality Assurance function along with a Quality Operations group that is a part of the Clinical Development organization. Together, the two groups provide the foundation for a risk-based, proactively managed Quality System across Global Clinical Development ensuring regulated clinical trial activities are:

Conducted with a high level of quality;
Conducted according to regulatory requirements;
Consistent with industry best practices.

These objectives are achieved through:

Maintenance of a robust set of written standard operating procedures (SOPs) with staff adequately trained against them;
A compliance monitoring program to ensure adherence to the SOPs and drive inspection readiness;
A well-defined Corrective Action/Preventive Action (CAPA) management process that promotes a systematic approach to dealing with critical/major issues and enabling study teams to effectively apply real-time lessons learned;
Execution of audits on our investigative sites, vendors, and internal processes/systems.