InCROM has been supporting Phase I trials since 1983. Our know-how and experience gained through the years have made us proficient in supporting even the highly specialized studies such as FIH (First in Human) and FIJ (First in Japanese) studies. No matter the study type, for example, BE (biological equivalence) studies, vaccine studies, pharmacokinetic studies of anticancer drugs and medical narcotics, and even bronchoalveolar lavage (BAL) pharmacokinetic studies which require special techniques, services we provide are highly effective and efficient.

Examples of InCROM Supported Clinical Studies

・First in Human studies
・First in Japanese studies
・Drug-drug Interaction (DDI) studies
・Bioequivalence studies
・Skin Irritation studies (patch test/photopatch test)
・Biopharmaceutical and Biosimilar studies
・Antibodies studies
・Anticancer studies (in healthy adults)
・Bronchoalveolar Lavage (BAL) Pharmacokinetic studies
・Clinical Pharmacology studies in non-Japanese subjects
・Studies in pediatric/elderly subjects
・Vaccine studies
・Narcotic studies
・Investigator-initiated studies

Regulatory approvals in the past 5 years for which the Phase I trials were supported by InCROM

2022: ALS agent (scavenges free radicals and inhibits oxidative damage to motor neurons and other cells)
2022: Pneumococcal vaccine (precipitated 15-valent pneumococcal vaccine)
2021: Cold syndrome treatments (ibuprofen, ambroxol hydrochloride, etc.)
2021: Anticancer agent (tropomyosin receptor kinase inhibitor)
2021: Cancer cachexia agent (ghrelin-like agonist)
2021: Enterolavage agent
2020: Renal anemia agent (HIF-PH inhibitor)
2019: Antimicrobial agent (quinolone)
2019: Anti-hypertensive agent (selective aldosterone antagonist)
2019: Antibiotics (macrolide)
2019: Anti-influenza agent (neuraminidase inhibitor)