Shanghai Clinic Leader Pharmaceutical TEC. Co., Ltd. was established in 2016 and operates as a subsidiary to Shanghai Unionlab Co., Ltd. It is dedicated to CRO fields that offering clinical study operation services in the oncology area. The founder of Clinic Leader Pharmaceuticals comes from a first-rate pharmaceutical company and has been over ten years working experience. Bei Lin has successful experience in new drugs development especially in the oncology，who familiar to the process from project implementation to entering the market. She has worked according to the principle of “beginning with the end in mind”, and kept a foothold with current clinical needs, through changes in the diagnosis and treatment of diseases and through different market conditions, and in drug research phase, our firm need to combine the characteristics of target medicinal products make the risk management plan that in order to achieve the value of the medicinal products and provided key strategic opinions on the drug research process. Our firm make deeply the cooperation with pharmaceutical company in the whole process for new drug development to make the strategy based on the standpoint of sponsor and the perspective on drug development.
Working on the foundation of a rational development strategy, our team have combined the characteristics of the target medicinal products. Based on the scientific basis and business planning of clinical development while also considering the requirements of legislation and supervision, our team have formulated clinical research plans and key information, and has established key decision points and Go/No-go criteria. Our team have established clinically operable clinical protocols and supporting documentation for various stages.
The headquartered based on Shanghai, the branch offices distribute in Beijing, Guangzhou, Shenyang, Harbin, Chengdu, Shijiazhuang, Xi’an, Nanjing, Chongqing, and Xiamen, the Clinical research association distribute above area. Our employee covering the first line clinical centers of oncology in domestic country to make comprehensive, systematic, high-quality, efficient clinical services to sponsors.
Union Image Pharmaceuticals is specialized as a third-party independent radiology review committee (IRC) service. It is a subsidiary of Shanghai Unionlab Co., Ltd. Union Image Pharmaceuticals is dedicated to promoting accurate medical treatment through the expert interpretation of medical imaging. It empowers the exploration and development of innovative drugs and treatment methods so that the patient can accept better treatment sooner.
Based on profound understanding the requirements of clinical trial work, it empowers smart technology, and with real knowledge of leader of the opinions of the industry, Union Image Pharmaceuticals can provide a specialized service in independent image assessment for clinical trials and image data mining. The Union Image team has a rich working experience and expert capabilities. Promoting accurate medical treatment through the expert interpretation of medical imaging, it empowers the exploration and development of innovative drugs and treatment methods so that the patient can accept better treatment sooner.
The IRC service reviews data throughout the whole clinical trial process. It can carry out third-party independent assessment according to the needs of clinical trials using human-centered, subjective judgements and therapeutic indicators from empirical assessment. This achieves an increased objectivity and reproducibility of data evaluation and reduced human judgement bias.
“The earlier the better“. With this medical image assessment brought into early-stage clinical trials , it is possible to provide a confidence about setting the endpoints for the assessment of treatment efficacy for the phase II and phase III trials of subsequent implementation as well as the reference basis of calculate the number of subjects.
Union Laiya (Shanghai) Data Technology Co., Ltd. is a holding company of Shanghai Unionlab.
Union Laiya is dedicated to creating a brand-new, highly effective, compliance, multi-dimensional delivery platform and team of data management and biostatistics. Based on a data format in line with international CDISC standards and according to the NMPA data guideline as dataflow of principle provide a differentiated and customized service. Using user-customized data tools, it is possible to carry out data management and feedback more quickly, ensuring data security and quality while also carrying out a multi-dimensional check of data trends and issues according to the needs of the project. Our biostatistics teams implement internationally leading CDISC standards, with meticulous and rigorous process design, and fulfill every requirement of implementing statistical analysis plans. They use differentiated innovative tools to speed up the clinical trial process, applying Bayesian statistics methods, using innovative trial design methods in the ascending dose of phase Ia to improve development efficiency, and using multi-dose, multi-indication concurrent expansion in the expansion cohorts of phase Ib to save on the amount of clinical trial samples, improve flexibility, and save development time. By making full use of data from every stage in designing the trial, statistical efficiency can be improved and development time shortened.
START Shanghai Company Limited is a holding company of Shanghai Unionlab.
Relying on clinical research institutions, START creatively integrates the operation mode of SMO (clinical trial site management organization) to carry out embedded management of clinical trials.
In December 2016, START and Dongfang Hospital Affiliated to Tongji University (Shanghai Dongfang Hospital) signed a cooperation framework agreement to establish Shida Dongfang new drug phase I clinical trial center. Shida Dongfang new drug phase I clinical trial center is led by Professor Li Jin, director of the Department of oncology, and its daily operation and management. The center is equipped with a professional clinical research team. Ensure that the trial process meets the requirements of ICH-GCP and China GCP, ensure the accuracy and scientificity of clinical research data, collect data according to international standards, establish a unified standardized process specification, and provide clinical trial services to large multinational and domestic pharmaceutical enterprises as well as small and medium-sized innovative biotechnology companies.
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ClinElite(Shanghai) Pharmaceutical Research and Development Co., Ltd. is geared towards the request of employment costs and risk control of R&D of pharmaceutical companies, that provide expatriate services relating to Job position for clinical development, improve the flexibility of human resources for pharmaceutical companies, and solve some of the important issues in the market.
Pharmaceutical company HC Budget
The speed of CTP and HGRAC approval influences the progress at which pharmaceutical companies launch projects
The suspension and termination of clinical research projects can cause a loss and re-allocation of personnel
Personnel unprofessionalism and division of labor are not clear can influence the requirements and quality for clinical trial projects
Different requirements of the allocation of personnel relating to clinical with different clinical stages.
The goal of ClinElite expatriate services is to provide high-quality, efficient, and stable outsourced service teams for clients.
Shanghai Yaoyan Intelligent Medical Treatment Technology Co., Ltd. is a solely domestically financed innovative SMO (site management organization). Yaoyan Intelligent has set up specialized big data and AI technology development teams, medical teams, SMO operation teams, and clinical support teams to provide clinical trial management systems and SMO of integrated clinical research services for clinical research centers and sponsors. Through smart clinical research collaborative systems embedded into clinical research centers, achieving a smart guide for the accurate recruitment of subject, guide clinical research center operation. It reduces the rate of errors in clinical data, reduces the costs of clinical research, improve the conduct efficiency of clinical research, and improve the standard of quality of clinical research projects.
Shanghai UnionDX Technology Co., Ltd. includes a bioanalysis lab, a bioequivalence trial department, and a molecular diagnostics laboratory (in the proposal stage). Its scope of business covers CMC consult for the development of biological agents, and the clinical and preclinical biological sample analysis, PK statistical analysis and immunogenicity assessment of macromolecule and micromolecular innovative drugs/generic drugs, and generic drug consistency evaluation service. The members of the core team have many years’ experience in medicinal product development and many experiences in clinical studies. We uphold “devoted, specialized, and efficient” service purpose, and we are dedicated to providing more high-quality and efficient lab services for our clients so that promoting quickly to the market of new drug development.
The bioanalysis labs were established according to NMPA/OECD/FDA GLP standards, while also having LC-MS/MS, ligand binding assay, and cell-based assay analysis platforms. We provide a comprehensive service including method development, method validation, sample analysis, and PK statistical analysis for our clients. With U-IPAS smart laboratory information management tools, they are achieving efficient links with clinical research centers from sample transport to data transfer, thus meeting the demands for rapid PK/PD feedback in macromolecule and micromolecular new drug clinical research, and supporting dynamic decision-making in new drug clinical trials. Our firm have achieved the quality system certification of ISO 9001, the quality assessment of internal lab by the National Health Commission, a capability verification project by the China Certification and Inspection Organization, and a CNAS attestation pending by the China National Accreditation Service for Conformity Assessment.
The bioequivalence trial department provides a generic drug BA/BE assessment service, providing an integrated service from BE protocol design, clinical center screening, clinical operation, Audit, and bioanalysis to data and statistics analysis for our clients. We have established long-term cooperation with numerous phase I/BE clinical research centers. We have deployed the phase I clinical research and data management system of TrialOne® to bring about the program control of the clinical research process, satisfied the requirements for remote monitoring and audit, and ensures that projects are more compliant and efficient.
We strictly compliance with the the GLP standards of regulatory market.
We always pay attention to the latest requirements of regulations and technical guidelines, and the quality risk management of whole process.
We provide professional scientific opinions and lab data for the key decisions of drug R&D process for our client.
We truly stand in the position of the sponsor and formulate reasonable lab solutions from overall perspective of drug R&D.
Closed data loop with biological sample traceability as the core.
Seamless connection with clinical research center.
Support dynamic decision.