Experience

1. Studies & Services

1-1. Summary



Studies	Site Users	Patients	Regulatory Approvals
+5,700	+80,000	+1,800,000	+350

1-2. #No of Studies per Year and Phase

YEAR	P1	P2	P3	P4	IIT	MD	PMS	OS	BE	FS	Other	Total
2019	44	29	33	13	11	29	29	21	266	25	3	503
2020	74	67	37	21	41	35	49	40	317	61	11	753
2021	75	46	42	13	36	42	53	39	492	47	7	892
2022	88	32	40	17	38	50	55	33	347	65	14	779
2023	114	33	48	10	40	85	68	32	257	60	13	760
2024	176	43	61	17	38	74	71	42	238	75	16	851
Total	658	369	403	222	249	340	494	331	2133	331	59	5589

1-3. #No of Studies per Therapeutic Area and Phase

Therapeutic Areas	P1	P2	P3	P4	MD	IIT	PMS	OS	BE	FS	Other	Total
ALIMENTARY TRACT AND METABOLISM	41	28	64	36	0	23	53	32	388	102	110	775
CARDIOVASCULAR SYSTEM	28	8	61	36	0	17	67	74	324	4	4	619
ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS	71	80	14	25	0	55	83	28	16	5	15	387
NERVOUS SYSTEM	8	10	13	28	2	11	30	19	208	4	8	335
ANTIINFECTIVES FOR SYSTEMIC USE	24	33	29	16	0	5	47	13	94	0	7	268
BLOOD AND BLOOD FORMING ORGANS	14	31	14	9	1	18	15	29	113	0	6	249
MUSCULO-SKELETAL SYSTEM	16	27	23	15	4	7	21	8	116	6	13	246
RESPIRATORY SYSTEM	3	7	18	4	0	3	26	9	83	3	4	157
GENITO URINARY SYSTEM AND SEX HORMONES	7	3	10	3	0	5	11	10	84	8	8	141
VARIOUS	10	7	3	6	29	9	8	11	4	10	46	104
DERMATOLOGICALS	8	13	17	2	11	7	11	3	10	10	22	93
SENSORY ORGANS	11	16	18	9	0	2	12	7	1	2	4	80
SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS	1	1	3	4	0	3	6	6	7	0	0	31
ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTS	1	1	1	0	0	0	1	0	0	0	0	4
[UNKNOWN]	217	47	33	12	211	43	22	32	463	106	342	1211
NOT DEFINED	7	9	29	0	7	2	2	4	8	2	50	111

1-4. #No of Services per Year

YEAR	EDC	IWRS (IP)	IWRS (Random Only)	PRO	cubeSAFETY	CTMS	TMF	DM	SDTM
2019	503	30	23	1	41	3	.	17	.
2020	749	50	40	30	80	9	19	31	4
2021	891	96	42	40	77	30	16	31	4
2022	774	123	35	62	9	17	17	20	6
2023	736	112	58	46	12	29	25	18	.
2024	842	137	56	49	15	23	17	9	1
Total	4516	551	255	232	234	112	98	126	15

1-5. #No of DM Studies per Year

Year	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023
Total	1	12	11	12	18	21	17	31	31	20	18

2. Global Experience

2-1. US

Sponsor

Phase

Indication

Note

P** (Biotech)

II

Oncology

H** (Biotech)

I/II

LARS

(Low Anterior Resection Syndrome)

O** (Biotech)

II

COVID 19

Emergency Use Authorization expected in the 1st quarter of 2024

2-2. EU

Sponsor	Phase	Indication	Note
S** (Pharmaceutical company)	OS	NA	Bulgaria, Czechia, France, Poland, Romania, Russia, Ukraine
M** (Biotech)	III	NA	Russia
D** (Biotech)	Pivotal (Medical Device)	Transrectal Prostate Biopsy	Poland
S** (Biotech)	Pivotal (Medical Device)	Prediabetes	Hungary, Romania, Slovakia

2-3. Phase 3

Country	Regulation Agency	No of Studies
Korea	MFDS	More than 30 per year
Japan	PMDA	36
China	NMPA	12
Taiwan	TFDA	2
EU	EMA	2

2-4. Regulatory Body Inspection

In most regulatory authorities, conducting inspections solely for eClinical solutions is rare. Still, we have compiled the following summary in response to commonly asked questions from our clients. The parentheses next to the number of studies indicate the following categories:

Some eClinical solutions were included in the study approval inspection process.
Inspection on eClinical solutions.

Country	Regulatory Agency	No. of Studies	Notes
Korea	MFDS	>= 15 per year ⁽¹⁾
Japan	PMDA	10 ⁽¹⁾
China	NMPA	1 ⁽¹⁾ 3 ⁽²⁾	(1) Small cell lung cancer. (2) NMPA inspection on eClinical solutions used in China.
Rwanda	Rwanda FDA	1 ⁽²⁾	COVID-19 vaccine.
Philippines	Philippine FDA	1 ⁽²⁾	COVID-19 vaccine.
USA	FDA	First Half 2024: cubeSAFETY Second Half 2024: cubeCDMS and others	The FDA's inspection of cubeSAFETY was completed without any system-related findings.
Taiwan	TFDA	NA
EU	EMA	NA

2-5. Studies per Region and Phase

Region	P1	P2	P3	P4	MD	IIT	MS	OS	BE	FS	Other	Total
Korea	354	229	278	202	248	124	375	270	1857	259	572	4261
Japan	51	45	28	3	12	82	36	15	22	2	21	303
China	48	30	11	0	0	2	2	4	38	1	2	137
Taiwan	1	2	0	0	1	0	1	4	0	0	1	9
US	1	3	0	0	0	2	0	0	0	0	0	6
Europe	1	0	1	0	1	0	0	7	0	0	1	10
ROW	9	10	16	2	0	1	1	14	0	0	0	53