Clinical Pharmacology Unit (CPU)

CPU Team & Collaboration

Acrostar

Phase I, BA/BE, PK dedicated staffs

Multiple assignments at site
Additional administrative tasks at site
Passive potential subject search

Functions

SMO manager
Study nurse (SMA)
Study coordinator (SMC)
Pharmacist
Subject recruitment specialist
Operations specialist

Investigators (MMH)

Investigators: chest medicine,hematology, oncology, ICU

MMH Clinical Trial Office

Facility & Location

Facility

870 m2

34 beds (24 general beds, 10 phase I beds)

58 seats

Independent pharmacy, sample processing equipment, patient rooms

TrialOne system (electronic datacapture system)

Freezer (4°C, -20°C, -80°C), centrifuge (x3), physiological monitor (x10), electrocardiograph

Location

New Taipei City, Taiwan 5 mins walk from metro station

Study Experience

- Phase I PK
- New Formulation BA
- Biosimilar PK/PD
- ANDA BE

- Oral Dosage Form
- Topical Patch · Gel
- IM injection · IC injection
- IV Infusion, Bolus
- Inhalation
- Nasal spray
- Sublingual

400+ studies
Clients from US, EU, Taiwan, ASEAN, Japan, EMEA, China etc.

Healthy Volunteer Recruitment

Recruitment Method

Acostar volunteer pool
Advertisement(IRB approved)
Social media

Healthy Volunteers

Screens ~150 volunteers/month
Recruits 50-60 volunteers/month
Acrostar’s volunteer pool: 4,000+

Time Course

2-3 weeks/project

Screening Rate

40-50% success rate for general BA/BE

Regulatory Administration Audits

Taiwan FDA Inspection

8 times

U.S. FDA Inspection

2 times

Ministry of Health Malaysia Inspection

5 times

China NMPA

3 times

Sponsor Audits

MMH IRB Routine Inspection

10 times

Consultant Audit (for US ANDA)

2 times

Why Acrostar?

Experience

Accumulated know-how from over 400 Phase I, HV, PK, First in human, SAD, MAD studies.

Collaboration

Proven collaboration and strong working relationship with Novotech CRO, Novotech lab and Mackay Mcmorial Hospital.

Quality

Over 15 inspections by regulatory authorities and over 100 internal/external audits.

Subject Recruitment

Over 1,000 healthy volunteer pool, dedicated recruitment team, recruiting average 50+ healthy volunteers each month.

Cost Efficiency

Offers competitive quotation in collaboration with Novotech and Mackay Memorial Hospital.

Quality oriented, adhering to the principle

Taipei:10F, No.47, Minquan Rd., Tamsui District, New Taipei City 25173, Taiwan

Seoul:Bubong Building 6F, Teheran-ro 20-gil 18, Gangnam-gu, Seoul 06235 Republic of Korea

contact.acrostar@acrostarsmo.com