Contract Research Services

We can be contracted to conduct the following clinical research projects:

1. Investigational new drug (IND) clinical trial: phase I, II, III and Post-market clinical trial: Phase IV surveillance trial.
2. Bridging Study.
3. Medical device/IVD clinical trial.
4. Research study trial.
5. NHIRD Analysis and Site-level medical record database analysis.
6.  Patient Support Program.

Our Strength

1. Monitoring:

Our monitors are well experienced on device, biotech and pharmaceutical studies across a variety of medical specialties/therapeutic areas and are capable to support in below tasks in a timely and manner:
(A) Informed consent process
(B) IRB/TFDA application
(C) proper AE and SAE reporting
(D) Adherence to the protocol
(E) source documentation verification and data query clarification
(F) Investigational products management and accountability
(G) Investigating site training and support
(H) maintenance of study regulatory documents.

All activities are performed in accordance with ICH-GCP to ensure all investigational sites comply with all applicable regulations and protocol requirements.

2.Site Management:

Provides comprehensive site management services and ensures that every site level activity are efficiently managed and integrated.

3.Regulatory Service:

Regulatory support is crucial to all phases of the drug development process. Our qualified and dedicated personnel have abundant experience working with local regulatory authorities, which allows us to obtain study approvals in the shortest time possible. Our services include: Preparation of submission package, application for study approvals, Local insurance policies for patients, Drug labeling, and Regulatory Consulting Services.

4.Trial Design:

Our Medical Affair specialists and Statisticians support our clients from the beginning of study design. With their knowledge in the design and statistical analysis of highly complex clinical trials, we are at the first step of success clinical trial.

5.Data Management:

Our Data Management team provides a full range of customized data services in clinical studies. The team is dedicated to designing a project management solution that guarantees reliable and timely completion of study milestones, so as to provide the highest level of data integrity and consistency across studies with the flexibility of delivering client-specific database structure.
In addition to traditional data management services, we offer sponsors Electronic Data Capture (EDC) Systems that bring more immediate access to study data.

6.Statistics:

Our Biostatisticians have excellent professional skills and experience in providing statistical analysis on data of clinical studies. We provide well-designed, rapid and accurate analytical services to our sponsors, complying with ICH-GCP guidelines.

7.Final Report:

Our Medical affair staff are highly qualified to organize, write, edit and compile the range of medical and scientific documentation that our clients may require.

Our Experience

Regulatory Affairs

• Regulatory Affairs had been contracted 2-3 studies, which each study involving 20 or more investigating sites. Submission works were completed within timeframe, complying with regulatory requirements. About 50 investigating sites throughout Taiwan are involved, including medical centers and local hospitals.

Project Management and Monitoring

• Clinical Research dept., under which CRA and PM are involved, once was contracted a Phase II trial on herbal new drug and successfully completed it. The trial passed TFDA GCP inspection without any deficiency.
• Also we completed a trial of special nutrition (food) ahead of the timeframe, with few subjects in the country may meet the inclusion criteria.
• In 2016, we were contracted a phase III study of a niche drug for high blood-pressure. The trial was half-way given up by another CRO and the sponsor was fallen behind the timeframe. We fully supported the sponsor to catch up the timeline and completed the trial smoothly.
• CRO also conducted a study on rectal cancer and completed recruitment ahead of the study timeline.

Data Management and Statistical Analysis

• We were once contracted 2-3 large, complex registry studies, each recruited about 3,000 subjects. DM met the timeline of data transmit and data clean, and supported sponsor to complete data validation and statistical analysis ahead of the timeline. Afterwards, several sub-analysis were conducted to help sponsor publish relevant results in medical/science journals.

Medical Affairs

• Besides protocol and report writing within requested timeframe, MA had once supported sponsors and investigators on medical writing, and submitted the papers to commonly-acknowledged journals with acceptance.

For many years, FBC CRO Division has been conducting wide range of clinical trials successfully, and having trials passed TFDA GCP inspection. We are well acknowledged with our efficiency, quality and compliance to regulations. Also, we are one of few CROs in Taiwan that has complete working procedures and abundant experience to conduct DSMB meeting.

 Furthermore, our out-standing proficiency in Statistics makes us the first choice in BIG clinical data analysis. We have been contracted various kinds of database analysis, including NHIRD and medical record database. FBC CRO is the first one to support you to successful clinical trials.

Contact Us

Industry Enquiry of Our Services

TEL:+886 2 2712-2211 ext. 7795

E-Mail: CRO_Service@fpg.com.tw