FIVERINGS strongly supports investigator-initiated clinical trials.

FiveRings Was Established To Support Investigator-Initiated Clinical Trials.

With extensive experience in conducting investigator-initiated clinical trials, our highly specialized
staff provides strong support for the implementation of investigator-initiated clinical trials.

FIVERINGS significantly reduces the burden on physicians or medical institutions n conducting
iinvestigator-initiated clinical trials, aand enables high-quality clinical trials to be conducted for use
in regulatory filings.

FiveRings CO., LTD.

Est. 2006

The Heart of FIVERINGS

We stand with investigators in the fight to ease patients’ suffering.

Supporting Investigator-Initiated Clinical Trials to Deliver Promising Treatments Sooner

In 2002, Japan’s Pharmaceutical Affairs Law (now known as the Pharmaceuticals and Medical Devices Act) was revised, making it possible for physicians to conduct investigator-initiated clinical trials (IITs). This regulatory change opened the door to developing treatments in areas where pharmaceutical companies may find it challenging to take the lead—such as rare diseases with very few patients or fields where academic research is already far advanced.

However, IITs place a significant burden on the principal investigator, as the physician must independently plan and manage the trial. Despite ongoing improvements in regulatory frameworks and the establishment of institutional support systems at universities and hospitals, conducting IITs remains a complex and demanding endeavor.

At FiveRings, we are committed to supporting investigator-initiated trials with the hope of accelerating the delivery of effective therapies to patients in need. With the shared dream of bringing new treatments to the bedside of those suffering from illness, our dedicated team works together to make this vision a reality.

Role of FIVEINGS

We provide support to ensure the reliability of clinical trials.

1

Organizing
We systematize the various elements required to conduct investigator-initiated clinical trials.

2

Consultation
We provide the necessary support to conduct investigator-initiated clinical trials with the level of reliability required for regulatory approval.

3

Operating
We provide robust support for the operation and management of clinical trials.

Key Features of FIVERINGS

We are always driven to improve and embrace new challenges.

1

Focus
FIVERINGS was established to support investigator-initiated clinical trials. We provide appropriate support for their preparation, operation, and management of investigator-initiated clinical trials.

2

Translational Research
FIVERINGS has extensive experience supporting investigator-initiated clinical trials conducted by universities and other institutions as part of translational research.。

3

Oncology
FIVERINGS has extensive experience supporting investigator-initiated clinical trials in the field of oncology, particularly cancer immunotherapy. We are actively engaged in supporting clinical trials involving immune checkpoint inhibitors, cancer vaccines, T-cell infusion therapies, and other forms of cancer immunotherapy.