Solutions
Clinical Research

The Tianjin Technology Innovation Center for Clinical Research (TICCR) approved by Tianjin Municipal Science and Technology Bureau, is a subsidiary of Asymchem Group (a leading CDMO).  TICCR pioneered the integration of Tianjin's innovative drug clinical research resources , thus creating a drug clinical research innovation service platform with comprehensive service capabilities such as international-level clinical research design, information-based data collection and management, and clinical research management, etc.


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The center integrates medical institutions with privileged resources (top tier authoritative hospitals in various fields jointly establish independent clinical research and innovation bases in oncology, hematology, general medicine and cardiovascular aspects, etc.) and clinical research service agencies in undertaking a full range of clinical research services for innovative drugs. Besides, the center integrates advantageous resources in the manner of innovative platforms, exerts cluster effects, solves the vexing points of clinical research on innovative drugs, makes breakthroughs in the bottlenecks of innovative drug development. The center brings in high-quality innovative drug projects and accelerate the product launch. It builds a national first-class innovative drug medical research and experimental platform in order to provide a series of clinical trial service which fulfills the requirements for the approval of new drugs in the United States, the European Union and China.


Preclinical studies

Preclinical research plays a vital role in the process of drug research and development. In order to meet the needs of the design of drug clinical research, we makes use of the powerful technical advantages of CMC terminal of Asymchem Group to intervene in advance and seamlessly connect the design and implementation of early clinical program of new drug research and development, IND declaration and subsequent stages clinical trials. Specifically, we assist the sponsor in the design of drug safety evaluation, pharmacodynamics, and pharmacokinetic research schemes, and provide the basis for the study of human pharmacokinetics, effectiveness, and safety of drugs.


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Clinical research

Identifying Principal Investigator (PI) and plan

● Quickly determining the PI and leading site based on the characteristics of the drug, indication selection, and institution / PI background check.

● Summarizing the results of pre-clinical and similar non-intervention research, then formulating clinical research strategies for drugs, and determine specific drug clinical trial plans based on Center for Drug Evaluation (CDE) technical requirements, clinical drug requirements, and competitive product development progress and combined with narrow pharmacoeconomic research data.


Clinical trial preparation

● Connecting, evaluating, and screening the participating institutions for clinical research.

● Promoting the progress of administrative approval of clinical trial institutions, such as project evaluation, IRB/IEC review, contracting, and site startup and other processes.

● Establishing a full-time HGRAC working group to improve the quality of submission documents and the efficiency of HGRAC approvals.


Clinical trial implementation period

● Using compliance, information, and intelligent methods to improve the efficiency of subjects recruitment.

● Standardizing operation and management of clinical research project : including clinical monitoring, medical monitoring, center management, data management, statistical analysis, pharmacovigilance, etc.

● Analysis of full-chain biological samples from hospital to laboratory, including cold chain transportation, sample testing and storage, etc.

● Third party audit services with CFDI inspection experience.


Clinical trial review period

● Compilation of summary report and application materials (clinical part) by professional medical team.

● Organizing experts in related fields to pre-review the application materials.


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Registration and application

● Assisting/guiding the sponsor to submit IND/NDA declared data.

● Inviting experts in related fields to guide / participate in Center for Drug Evaluation (CDE) technical communication meetings.


Post-market entry research

● Conducting phase IV clinical research in accordance with the latest national regulations.

● Conducting Real-world Study in order to better explore the clinical use value of marketed drugs.

● Conducting general pharmacoeconomic research to fully explore the accessibility of marketed drugs.

 

Innovation partner

● Nationwide strategic partnership with high-quality medical institutions in various disease areas.

● Close cooperation with all clinical trial institutions in Tianjin.

● Priority partnership of TEDA International Cardiovascular Hospital (ASYM-TICH).

● National Association in Oncology.

● National Association in Cardiovascular Diseases.

● Oncology/non-oncology early clinical research collaboration group (in preparation).


Supplier management

● Strict supplier selection system, after qualification verification, quality, technology and price control.

● Abundant qualified supply base to meet various customer needs and provide the most cost-effective service.

● Annual supplier capabilities assessment, tracking and evaluating the suppliers services we have cooperated.

● Strategic cooperation with high-quality suppliers, establishment of long-term and stable partnership to promote complementary advantages, mutual development, and strengthen consultation and coordination on strategic issues


TEDA International Cardiovascular Hospital Phase I clinical trial ward

TICCR Early Clinical Research Binhai Center


TEDA International Cardiovascular Hospital Phase I Clinical Trial Ward-TICCR Early Clinical Research Binhai Center (ASYM-TICH) comprises a complete animal experiment center, a basic research unit, the phase I drug clinical trial base and the Tianjin international  biomedical research Institute Central Lab, etc.


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Project experience

● Rich experience in Phase I-IV clinical trials of drugs, with outstanding cardiovascular expertise.

● Phase I clinical trial lab with extensive project experience carries out early clinical trials in accordance with international standards. It has passed NMPA   verification, third-party verification and sponsor inspection for many times.

● Complete the filing  of clinical trial institutions of medical devices (Filing number: Mechanical Procurement Agency 201800154), with rich experience in clinical trials of medical devices and diagnostic reagents.


Projects undertaken by Binhai Center and the qualifications recognized

● "Phase I Pharmaceutical Clinical Research Engineering Technology Center" approved by Tianjin Municipal Science and Technology Bureau.

● "GCP platform construction-innovative drug cardiotoxicity clinical evaluation technology platform” Project of Major National Science and Technology Programs in the "Twelfth Five-Year" Plan period.

● Annual supplier capabilities assessment, tracking and evaluating the suppliers services we have cooperated.

● Science and Technology Innovation Project of Binhai New Area "Construction of Translational Medicine Research Platform for Major Cardiovascular Disease ".


Postal Address
  • Asymchem Inc. 600 Airport Blvd PO Box 1310
  • Morrisville NC 27560 USA
Physical Address
  • Asymchem Inc.
  • 600 Airport Blvd., Suite 1000 Morrisville, NC 27560 USA
Contact Us
  • information@asymchem.com
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