From initial IRB review to first patient first visit (FPFV)

Within 1 Month from Initial IRB Review To FPFV

Study No.Target DiseaseSiteIRB Review DateFPFV DateNumber of Days Required
569CLIAllergic ConjunctivitisOPHAC HospitalJun 9, 2022Jun 11, 20222 days
495CLIType 2 diabetes mellitus (clinical study)OCROM ClinicMar 14, 2019Mar 20, 20196 days
496CLICold SyndromeOPHAC Hospital
ToCROM Clinic		Mar 14, 2019Mar 22, 20198 days
559CLIType 2 diabetes mellitus (clinical study)OPHAC HospitalDec 2, 2021Dec 13, 202111 days
564CLISeasonal Allergic Rhinitis (Clinical Research)OCROM ClinicFeb 3, 2022Feb 15, 202212 days
568CLIType 2 Diabetes Blood Draw (Clinical Research)OPHAC HospitalApr 28, 2022May 13, 202215 days
507CLIContact lensesOphthalmic practitionerOct 31, 2019日Nov 18, 201918 days
562CLIAllergic ConjunctivitisOPHAC Hospital
ToCROM Clinic		Feb 3, 2022Feb 22, 202219 days
470CLIType 2 DiabetesOCROM Clinic
ToCROM Clinic		Aug 3, 2017Aug 24, 201721 days
549CLIAGA (clinical research)OPHAC Hospital
ToCROM Clinic		Jul 29, 2021Aug 19, 202121 days
566CLIType 2 DiabetesOCROM Clinic
ToCROM Clinic		Feb 3, 2022Feb 24, 202221 days
463CLIType 2 diabetesOCROM Clinic
ToCROM Clinic		Jun 1, 2017Jun 24, 201723 days
466CLIAtopic Dermatitis (Clinical Research)OPHAC HospitalAug 3, 2017Aug 27, 2017日24 days
503CLIHypertriglyceridemia症OPHAC Hospital
OCROM Clinic
ToCROM Clinic		Sep 12, 2019Oct 6, 201924 days
485CLIGlaucoma6 ophthalmic practitioner facilitiesJul 12, 2018Aug 6, 201825 days
531CLISeasonal allergic rhinitisToCROM ClinicFeb 4, 2021Mar 3, 202127 days
567CLIContact dermatitis (clinical research)OCROM ClinicApr 28, 2022May 26, 202228 days
500CLIEye strainOCROM Clinic
ToCROM Clinic		Jul 11, 2019Aug 11, 201931 days

High Subject Enrollment Index Exceeding 50%

As part of the study feasibility assessment, based on our subject panel database, we are able to provide client the subject number forecast with clear rationale(s) and high confidence level.
Prior to study start, we develop the subject recruitment plan, and fine-tune per needed by revisiting the subject panel database. If actual enrollment does not progress per forecast indicated by the enrollment index, we revisit the recruitment plan and procedures, and make prompt adjustments necessary to increase the enrollment speed.

Enrollment Index for Clinical Trials Conducted at Heishinkai Study Sites
（Click here for details of the enrollment index）

Study No.Conducting medical institutionDisease namePhaseNumber of contracted cases (first time)Entry index (%)
419CLIOPHAC HospitalSeasonal allergic rhinitisⅢ20064
419CLIToCROM ClinicSeasonal allergic rhinitisⅢ21059
454CLIOPHAC HospitalAllergic ConjunctivitisⅢ6472
454CLIToCROM ClinicAllergic ConjunctivitisⅢ6470
503CLIOPHAC HospitalDyslipidemiaⅡa2064
503CLIOCROM ClinicDyslipidemiaⅡa2078
503CLIToCROM ClinicDyslipidemiaⅡa2071
524CLIOCROM ClinicObesityⅡb1085
524CLIToCROM ClinicObesityⅡb1070
535CLIOCROM ClinicDiabetic nephropathyⅡb570
535CLIToCROM ClinicDiabetic nephropathyⅡb562
545CLIOCROM ClinicInsomniaⅢ670
546CLIOCROM ClinicPresbyopiaⅡb2561
546CLIToCROM ClinicPresbyopiaⅡb2071
556CLIOCROM ClinicDiabetic peripheral neuropathic painⅡa869
556CLIToCROM ClinicDiabetic peripheral neuropathic painⅡa876
1085PBOPHAC HospitalInfluenza vaccineⅢ32066
1085PBOCROM ClinicInfluenza vaccineⅢ35065
1085PBToCROM ClinicInfluenza vaccineⅢ35067
1123PBOPHAC HospitalCOVID-19 vaccineⅡ/Ⅲ11559
1123PBOCROM ClinicCOVID-19 vaccineⅡ/Ⅲ11576
1123PBToCROM ClinicCOVID-19 vaccineⅡ/Ⅲ19058

Heishinkai Study Sites Capabilities

Heishinkai study sites are capable of conducting studies across a wide range of therapeutic areas.
Studies requiring special equipment such as PSG (Polysomnography) and colonoscopies, as well as population-specific studies such as non-Japanese and the elderly patient studies have been conducted at all Heishinkai study sites. FIH trials and various vaccine studies including COVID-19 can also be conducted at our sites.

Phase I Clinical Pharmacology Studies

Heishinkai has been recognized by the industry for our knowledge and experience gained from over 30 years of conduct of clinical pharmacology studies, and have conducted many highly specialized studies such as FIH (First In Human) and FIJ (First In Japanese) studies. Also, our infra is proficient in conducting studies no matter the study type, including studies that require special study procedures such as BE studies, vaccine studies, pharmacokinetic studies of anticancer agents and narcotics, and intra-alveolar pharmacokinetic studies.

Vaccine Studies

Our vaccine study subject recruitment ability is of top class in Japan, with a record high of a total of over 2000 subjects enrolled in a single season and OPHAC Hospital alone enrolled more than 750 subjects including those under the age of 20.
In 2021, a total of 1020 subjects were enrolled in one month. We have also supported a few COVID-19 trials with a few hundred subjects each.

Patient Studies

We have conducted more than 600 patient trials to date, and have outstanding recruitment performance including the successful enrollment of 765 pollinosis patients in a single season. In addition, for lifestyle-related disease trials such as diabetes, hypertension, and dyslipidemia, we maintained the enrollment of over 500 patients per year and over 100 patients for a single-sited trial. We can also conduct clinical pharmacology inpatient trials, and have conducted 46 trials (mostly lifestyle-related diseases) that included more than 1000 patients.
Examples of our large-scale recruitment capability – we can commit to enrolling 100 or more patients in 2-3 months for one untreated type 2 diabetes trial, or 100 or more patients in 1-2 months for one dyslipidemia trial.
Key Achievements

Contents
【Phase I studies】
･ Bioequivalence study: 288 patients included in 1 study
･ FIH/FIJ study
･ Conducted studies on white healthy adult subjects, anticancer agents, BAL (bronchoalveolar lavage), and intestinal lavage agents
 
【Vaccine study】
･ COVID-19 vaccine study: 420 subjects included in 1 study
･ One study at 3 sites with 1,020 subjects (elderly)
･ 1 study at 1 site, 750 cases (including minors)
 
【Lifestyle-related disease study】
･ Dyslipidemia: 1 study (288 cases) (1,955 cases included in the past)
･ Type 2 diabetes: 9 studies were conducted for 651 cases per year (4,476 cases were included in the past)
 
【Allergic Rhinitis Study】
･ Seasonal rhinitis: 615 cases were included in 1 study at 3 sites (6,197 cases were included in the past).
･ Perennial rhinitis: 765 cases were included in 1 study at 4 sites (2,120 cases were included in the past)
 
【Other】
･ Insomnia study: 1 study (42 cases)
･ Sleep apnea syndrome study: 1 study (12 cases included)
･ Lipid disorders study: 1 study (110 cases at 3 sites)
･ Type 2 diabetes mellitus CGM study: 1 study (2 sites, 60 subjects)
･ Alopecia areata study: 80 cases at 2 sites in 1 study
･ Knee osteoarthritis/low back pain study: 10 studies (500 subjects)
･ Obesity Study: 20 studies (448 subjects)
･ Atopic dermatitis study: 5 studies (84 subjects)
･ Incontinence/Hyperplastic Prostate Study: 10 studies (245 subjects)

Heishinkai Subject Panel

One of the strengths of Heishinkai’s subject panel is the inclusion of medical examinations at time of panel registration. This allows for nearly real-time candidate identification based on their medical and lab test results. Another strength is the effort put in to recruit registrants who are collaborative and have a good understanding of the value of clinical trials. This contributes to the nearly 100% of willing consent. In addition, Heishinkai’s affiliate InCROM Inc. has a dedicated volunteer recruitment & management department as well as a dedicated call center to provide care and support for subjects.

Number of Subject Registrations by Age Group

 OsakaTokyoTotal number
HealthPatientsHealthPatients
MaleFemaleMaleFemaleMaleFemaleMaleFemale
Under 10s7900100017
10s93115463553553629462
20s5,21240850229235381451426,774
30s4,01854377459061493424366,813
40s9832831,2081,18351587408555,361
50s2302401,7871,74755611,2831,3466,749
60s951101,4261,15925241,1507294,718
70s35381,03271416127473962,990
Over 80s2815530361321961131,248
Total10,7011,7617,3056,0813002994,6394,04635,132

（as of June 1, 2023）

Number of Subject Registrations by Indications

 OsakaTokyoTotal
MaleFemaleMaleFemale
Diabetes mellitus1,7365031,2062913,736
Hypertension2,4001,0251,4755785,478
Dyslipidemia2,9021,8812,1151,4128,310
Seasonal allergic rhinitis3,4173,3342,0732,24411,068
Perennial allergic rhinitis2,0022,2681,0661,2966,632
Hyperuricemia1,10172606371,816
Atopic dermatitis6974521831711,503
Glaucoma194166168127655
Dry eye3801,0843187542,536
Bronchial asthma3963541521571,059
Urinary incontinence4127923113456
Prostatic hypertrophy39202250617
Knee arthritis137354124244859
Low back pain318268233141960
Osteoporosis1833514134501
Depression61395332185
Allergic conjunctivitis5548491,6621,8864,951
Sleep apnea101198713220
Insomnia3244002752451,244
Obesity5613153240948
Constipation176553833161,128

（as of June 1, 2023）