Our Strength

• Trial Design, Reports, and Medical Document Writing

Our medical affairs team possesses exceptional expertise in medical writing. Clinical trial services cover a wide range of areas, including early-stage trial abstract planning, protocol writing, informed consent form (ICF) design, questionnaire authorization processes, and preparation of IRB review documents. During trials, we provide interim analysis reports, DSMB meeting charters, and DSMB meeting execution. After trial completion, we offer CSR (Clinical Study Report) writing, manuscript editing for journal publication, formatting revisions, submission process support, and other medical affairs-related services.

• Regulatory Submissions

In the development of pharmaceuticals, medical devices, health supplements, and special nutritional products, regulatory support is a critical factor for success. Formosa Biomedical Technology Corporation has an experienced regulatory affairs team dedicated to helping clients comply with Taiwanese regulations and obtain necessary approvals.

Our services include assistance with TFDA and IRB protocol reviews, sample and imaging export applications, reviews by the Radiation Protection Committee and Biosafety Committee, subject insurance inquiries, and preparation of regulatory application documents for health supplements and special nutritional products. We provide comprehensive regulatory compliance consulting to ensure your products and research meet Taiwan's regulatory standards, supporting smooth progress at every development stage.

• Clinical Monitoring

Our CRA team has extensive experience and enthusiasm, providing efficient support to clinical teams for the successful completion of tasks:

(a) Management of informed consent processes

(b) Assistance with TFDA/IRB trial applications

(c) Reporting and handling of AE/SAE events

(d) Comprehensive trial monitoring

(e) Data verification and validation

(f) Management and tracking of investigational products

(g) Training and support for trial sites

(h) Assistance with the preparation and management of required documents

All activities strictly adhere to ICH-GCP guidelines, ensuring compliance with regulatory authority requirements.

• Data Management and Analysis

Our data management team is dedicated to offering diverse data processing services tailored to client needs, including customized database design. All clinical data processing workflows meet the highest standards of integrity and reliability.

In addition to traditional paper-based data management, we provide the option to implement an Electronic Data Collection (EDC) system for rapid and real-time data processing. Our statistical analysis team is highly skilled and experienced, delivering high-quality statistical analysis services for clinical trials.

Our services are characterized by speed, accuracy, and comprehensiveness, fully compliant with ICH-GCP guidelines.

• Site and Project Management

Our clinical trial project management team provides professional and systematic services to ensure the efficient execution and quality control of trials. We manage all stages of the trial process, including trial design, initiation, execution, monitoring, and closure. Through strict time management and resource allocation, we assist clients in achieving their clinical trial objectives successfully.

Our services adhere to ICH-GCP guidelines, ensuring compliance, data integrity, and fulfillment of both client and regulatory requirements.

• Trial Reports and Medical Document Writing

Our medical affairs team possesses exceptional expertise in medical writing, providing comprehensive services such as protocol writing, trial report preparation, and drafting, editing, and organizing other medical documents.

Our Experience

Regulatory Affairs Department
With experience in submissions to nearly 60 hospitals across Taiwan, including medical centers, regional hospitals, and local hospitals, we offer comprehensive coverage nationwide. Whether preparing submission documents or obtaining approvals, we ensure full compliance with regulatory requirements and provide professional submission strategies to help clients achieve their goals and meet timelines.

Clinical Research Department
Conducts clinical trials across all phases, ensuring smooth inspections and approval by the TFDA;
Successfully executed clinical trials for special nutritional products (foods), completing subject enrollment ahead of schedule despite challenges in recruitment;
Took over an ongoing Phase III clinical trial for a new hypertension drug, completed enrollment successfully, and resolved delays in clinical monitoring progress;
Conducted a rectal cancer clinical trial, accurately predicted potential issues, prevented analytical errors, and ensured successful inspections, leading to product approval and market launch.

Data Management Department
Successfully managed multiple large-scale retrospective studies involving thousands of patients, achieving planned goals and timelines through professional execution of data transfer and data clarification;
Provided statistical analysis support, enabling sponsors to utilize the database for multi-dimensional analyses and international journal publications;
Leveraged data management expertise to assist sponsors in pharmacovigilance, including archiving and storing adverse event records, while offering diverse statistical analyses to assess drug risks.

Medical Affairs Department
Specializes in drafting medical and scientific documents and research-related reports. The Medical Affairs team brings extensive academic and clinical research experience, covering:
Clinical trials Phase I~IV, bioequivalence (BE) studies, cell therapy, medical devices, IVD reagents, special nutritional products, and investigator-initiated trials (IIT);
Optimizing trial designs to increase success rates, supported by Formosa Plastics Group’s expert medical consultants for comprehensive professional services;
Assisting with medical journal editing and submissions, leveraging expertise in trial design and regulatory responses to increase publication success rates;
Supporting clients in executing DSMB meetings and establishing connections with KOLs for planning academic events, including CME/RTD (Continuing Medical Education/Round Table Discussions).

For many years, we have focused on efficiently conducting clinical trials, passing multiple TFDA GCP inspections, and successfully assisting clients in obtaining marketing approvals. Our commitment to excellence ensures compliance with domestic and international regulatory requirements.
Formosa Biomedical is one of the few CROs capable of executing DSMB operations with established workflows and extensive experience. We are dedicated to providing in-depth professional advice and comprehensive services. Please feel free to contact us.

Contact Us

Industry Enquiry of Our Services

TEL:+886 2 2712-2211 ext. 7798

E-Mail: CRO_Service@fpg.com.tw